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Validation of the functional assessment of cancer therapy cognitive scale with bone marrow transplant patients

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Validation of the functional assessment of cancer therapy cognitive scale with bone marrow transplant patients
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Jacobs, Sheri R
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Cognitive complaints
Quality of life
Cognitive functioning
Neoplasms
Psychometrics
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ABSTRACT: Research has demonstrated that cancer patients report problems with cognitive functioning related to their cancer and their cancer treatments. Cognitive complaints refer to subjective reports of problems such as decreased memory, attention, concentration, and language skills. These problems with cognitive functioning can interfere with a persons quality of life. The current measures of cognitive complaints have poor or unknown psychometric properties. Therefore, the present study sought to examine the psychometric properties of a newly developed measure of cognitive complaints for cancer patients, the Functional Assessment of Cancer Therapy Cognitive Scale (FACT-Cog). Eighty-two patients were administered a comprehensive battery of neuropsychological tests assessing memory, executive functioning, motor, and attention, as well as a battery of psychosocial measures six months or twelve months after receiving a bone marrow transplant.Results indicated that the internal consistency reliability of the FACT-Cog was high. Concurrent validity was evidenced by the significant relationship of the FACT-Cog to another measure of cognitive complaints. Convergent validity is evidenced by the significant relationship of the FACT-Cog to measures of depression, fatigue, anxiety, mental well-being, and physical well-being. Divergent validity was evidenced by the lack of significant relationship of the FACT-Cog to a measure of extroversion. In contrast, there was limited support for the criterion validity of the FACT-Cog as evidenced by the limited significant relationships with neuropsychological test scores. The FACT-Cog did not demonstrate superior psychometric properties to an existing measure of cognitive complaints (EORTC-CF).
Thesis:
Thesis (M.A.)--University of South Florida, 2004.
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by Sheri R. Jacobs.
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Validation of the Functional Assessment of Cancer Therapy Cognitive Scale with Bone Marrow Transplant Patients by Sheri R. Jacobs A thesis submitted in partial fulfillment of the requirements for the degree of Master of Arts Department of Psychology College of Arts and Sciences University of South Florida Major Professor: Paul B. Jacobsen, Ph.D. Margaret Booth-Jones, Ph.D. William P. Sacco, Ph.D. Douglas Rohrer, Ph.D. Date of Approval: December 3, 2004 Keywords: cognitive complaints, quality of life, cognitive functioning, neoplasm, psychometrics Copyright 2005, Sheri R. Jacobs

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i Table of Contents List of Tables iii Abstract iv Introduction 1 Review of Cognitive Complaints Literature 2 Review of Cognitive Complaints and Cognitive Functioning Literature 8 The Functional Assessment of Cancer Therapy Cognitive Scale 19 Aims 20 Hypotheses 22 Method 24 Participants 24 Procedure 24 Measures 25 Demographic, Disease, and Treatment Measures 25 Psychosocial Measures 25 Perceived Cognitive Functioning 25 Depression 26 Anxiety 27 Fatigue 27 Health-Related Quality of Life 28 Extroversion and Neuroticism 28 Neuropsychological Measures 29 Estimated Intellectual Functioning 29 Attention 29 Memory 29 Executive Functioning 30 Motor 32 Data Reduction 32 Statistical Analyses 32 Results 36 Relationship of FACT-Cog to Demographic Characteristics 36 Relationship of FACT-Cog to Psychosocial Variables 37 Relationship of FACT-Cog to Neuropsychological Variables 40 Relationship of EORTC-CF to Demographic Variables 42 Relationship of the EORTC-CF to Psychosocial Variables 42 Relationship of the EORTC-CF to Neuropsychological Variables 43

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ii Discussion 45 Reliability 45 Concurrent Validity 45 Convergent Validity 46 Divergent Validity 47 Criterion Validity 47 Demographic and Multivariate Analyses 49 FACT-Cog Total Score in Comparison to the EORTC-CF 51 Limitations 53 Clinical Implications 54 Future Directions 54 References 70 Appendices Appendix A: Functional Assessment of Cancer Therapy Cognitive Scale 79 Appendix B: EORTC QLQ-C30 Cognitive Functioning Scale 84 Appendix C: Center for Epidemiological Studies – Depression 85 Appendix D: State-Trait Anxiety Inventory 86 Appendix E: Fatigue Symptom Inventory 88 Appendix F: Medical Outcome SF-36 Health Survey 90 Appendix G: NEO – Five-Factor Inventory 94 Appendix H: Background Interview 98 Appendix I: National Adult Reading Test 101 Appendix J: Conners’ Continous Performance Task-II 102 Appendix K: California Verbal Learning Test 104 Appendix L: Logical Memory 107 Appendix M: Visual Reproduction 110 Appendix N: Digit Symbol 112 Appendix O: Trail Making Test A 113 Appendix P: Trail Making Test B 114 Appendix Q: Controlled Oral Word Association 115 Appendix R: Stroop 116 Appendix S: Grooved Pegboard 117

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iii List of Tables Table 1 Demographic Characteristics of Sample 57 Table 2 Clinical Characteristics of Sample 58 Table 3 Correlational Analyses of FACT-Cog and EORTC-CF with Demographic and Clinical Variables 59 Table 4 Correlational Analyses of FACT-Cog and EORTC-CF with Psychosocial Variables 60 Table 5 Regression Analysis of the FACT-Cog Total Score 61 Table 6 Regression Analysis of the FACT-Cog Cognitive Domain 62 Table 7 Regression Analysis of the FACT-Cog Interference of Functioning 63 Table 8 Regression Analysis of the FACT-Cog Quality of Life Domain 64 Table 9 Correlational Analyses of FACT-Cog and EORTC-CF with Neuropsychological Test Performance (Continuous Measures) 65 Table 10 Correlation of FACT-Cog and EORTC-CF with Neuropsychological Test Scores (Continuous Measures) 66 Table 11 Correlational Analyses of FACT-Cog and EORTC-CF with Neuropsychological Test Performance (Impairment Classification) 67 Table 12 Correlation of FACT-Cog and EORTC-CF with Neuropsychological Test Scores (Impairment Classification) 68 Table 13 Regression Analysis of the EORTC-CF Score 69

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iv Validation of the Functional Assessment of Cancer Therapy Cognitive Scale with Bone Marrow Transplant Patients Sheri R. Jacobs ABSTRACT Research has demonstrated that cancer patients report problems with cognitive functioning related to their cancer and their cancer treatments. Cognitive complaints refer to subjective reports of problems such as decreased memory, attention, concentration, and language skills. These problems with cognitive functioning can interfere with a person’s quality of life. The current measures of cognitive complaints have poor or unknown psychometric properties. Therefore, the present study sought to examine the psychometric properties of a newly developed measure of cognitive complaints for cancer patients, the Functional Assessment of Cancer Therapy Cognitive Scale (FACT-Cog). Eighty-two patients were administered a comprehensive battery of neuropsychological tests assessing memory, executive functioning, motor, and attention, as well as a battery of psychosocial measures six months or twelve months after receiving a bone marrow transplant. Results indicated that the internal consistency reliability of the FACT-Cog was high. Concurrent validity was evidenced by the significant relationship of the FACT-Cog to another measure of cognitive complaints. Convergent validity is evidenced by the significant relationship of the FACT-Cog to measures of depression, fatigue, anxiety, mental well-being, and physical well-being. Divergent validity was evidenced by the lack of significant relationship of the FACT-Cog to a measure of extroversion. In contrast, there was limited support for the criterion validity of the

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v FACT-Cog as evidenced by the limited significant relationships with neuropsychological test scores. The FACT-Cog did not demonstrate superior psychometric properties to an existing measure of cognitive complaints (EORTC-CF). Future research should investigate the relationship of cognitive complaints to cognitive performance utilizing longitudinal designs, other clinical populations, and neuropsychological tests that require sustained effort.

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1 Introduction Cognitive functioning among adult cancer patients has received increasing attention in recent years. Research suggests that problems with cognitive functioning have a large impact on quality life, interfere with the ability to function in daily activities, and affect educational and career choices. Therefore, it is important to correctly identify and assess problems associated with cognitive functioning. Cognitive functioning has been assessed in two ways: by measuring cognitive performance on standardized neuropsychological tests and by obtaining self-reports of cognitive complaints. Although methodology for assessing cognitive performance is fairly well developed, the same cannot be said for the assessment of cognitive complaints. Current methods for measuring cognitive complaints either lack sound psychometric properties or have unknown psychometric properties. Recognizing the need for a reliable and valid measure, Wagner, Sweet, Cella, and Doninger (2002) have developed the Functional Assessment of Cancer Therapy Cognitive Scale (FACT-Cog). This measure of cognitive complaints is composed of behaviorally-based items in an effort to minimize the impact of distress unrelated to cognitive abilities. The aim of the present study was to examine the psychometric properties of this newly developed instrument using bone marrow transplantation (BMT) patients as the validation sample. The following section will evaluate different methods of measuring cognitive functioning in cancer patients. First, studies assessing cognitive complaints but not cognitive performance in cancer patients will be discussed. Next, studies assessing both cognitive complaints and cognitive performance will be reviewed. Finally, the development and structure of the FACT-Cog will be discussed.

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2 Review of Cognitive Complaints Literature Although there is no consensus, cognitive complaints typically refers to subjective difficulties with memory, attention, concentration, and language skills (Olin, 2001). Cognitive complaints, such as difficulties with attention and concentration, may overlap with symptoms of depression and fatigue. However, unlike depression and fatigue, cognitive complaints can include problems with mental acuity, verbal and nonverbal memory, verbal fluency, and the impact of decreased cognitive abilities on a person’s functioning and quality of life. Although there is overlap among depression, fatigue, and cognitive complaints it is possible to distinguish them, and anecdotally patients report cognitive complaints without experiencing depression or fatigue. This highlights the importance of reliably and validly measuring cognitive complaints. A variety of methods have been used to assess cognitive functioning in cancer survivors. Some studies have relied on subjective measures to assess cognitive complaints without using objective measures of cognitive performance. Five such studies can be identified. Two studies used the Sickness Impact Profile (SIP) Alertness Behavior Scale (Bergner, Bobbitt, Carter, & Gilson, 1981) and the Profile of Mood State (POMS) Confusion Scale (McNair, Lorr, & Droppleman, 1971) and three studies used the European Organization for Research and Treatment of Cancer – Quality of life Questionaire-C30 Cognitive Functioning Scale (EORTC-CF; Aaronson, Ahmedzai, Bergman, Bullinger, & Cull, 1993) to assess cognitive complaints. The first study, by Andrykowski, Henslee, and Barnett (1989), used the SIP Alertness Behavior Scale and the POMS Confusion Scale to assess cognitive complaints. The SIP Alertness Behavior Scale consists of ten items assessing the presence of

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3 difficulties in memory, attention, and concentration. Higher scores indicate greater dysfunction. The POMS Confusion Scale consists of seven descriptors, such as, ‘confused’, ‘unable to concentrate’, ‘muddled’, and ‘efficient’. Respondents indicate for the last week the degree to which each descriptor is characteristic of them. Higher scores indicate greater dysfunction. In this study, 16 allogeneic BMT patients were assessed two years following transplant and then again at four years post-transplant. Scores on the SIP Alertness Behavior Scale improved significantly from time one to time two. Scores at both assessments reflected more impairment in comparison to scores from a sample of renal implant patients and scores from a sample of chronic peritoneal dialysis patients. Scores on the POMS Confusion Scale remained stable across time and were similar to scores from the comparison samples. A second study by Andrykowski et al. (1990) also assessed cognitive complaints using the SIP Alertness Behavior Scale and the POMS Confusion Scale. Thirty allogeneic BMT patients were divided into three groups based on the amount of Total Body Irradiation (TBI) they had received: patients who received 900 cGy or less (N=13), patients who received 1200 cGy (N=9), and patients who received 1320 or 1400 cGy (N=8). After controlling for age, time post-BMT, education, and current psychological distress, the SIP Alertness Behavior Scale was found to be significantly positively related to TBI dose. The correlation between the POMS Confusion Scale and TBI dose only approached significance. Joly et al. (1998) used the EORTC-CF to assess cognitive complaints. The EORTC-CF consists of two items rated on a four-point scale (1=Not at all, 2=A little, 3=Quite a bit, 4=Very much). One item assesses difficulty with concentration and the

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4 other item assesses difficulty with memory. The sample in this study consisted of men with localized prostate cancer (N=71) and healthy controls (N=71). The prostate cancer patients were tested an average of four years post-treatment. No significant difference was found on the EORTC-CF between patients and controls. Hjermstad, Holte, Evensen, Fayers, and Kaasa (1999) also administered the EORTC-CF to measure cognitive complaints. The samples of cancer patients consisted of leukemia patients treated with high-dose chemotherapy and allogeneic BMT (N=41), lymphoma patients treated with high-dose chemotherapy and autologous BMT (N=51), and lymphoma patients treated with combination chemotherapy (N=85). Lymphoma patients who underwent autologous BMT reported significantly greater cognitive complaints than the other two cancer groups and the healthy controls. No significant differences existed between the leukemia patients treated with allogeneic BMT, the lymphoma patients treated with combination chemotherapy or the healthy controls. Green, Pakenham, Headley, and Gardiner (2002) used the EORTC-CF to measure cognitive complaints in 65 prostate cancer patients at baseline and 6 months posttreatment and 16 healthy controls over a similar time interval. As part of their cancer treatment, prostate cancer patients were randomized to an observation group or a hormonal therapy group. There was no significant difference in EORTC-CF scores between the observation group and the hormonal therapy group. There was also no significant change in scores from time one to time two in either group. As predicted, higher threat appraisal at baseline was significantly correlated with greater cognitive complaints at baseline and at 6 months. Contrary to the authors’ prediction that greater use of emotion or problem-focused coping would be correlated with lower levels of

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5 cognitive complaints, greater use of coping at baseline was significantly correlated with higher levels of cognitive complaints at 6 months. In summary, evaluation of group differences provides limited support for the validity of the cognitive complaint measures. Findings indicating that, as TBI dose for allogeneic BMT patients increased, scores of the SIP Alertness Behavior Scale also increased (Andrykowski et al., 1990) would be expected and, therefore, support the validity of the SIP Alertness Behavior Scale. However, findings indicating that scores on the SIP Alertness Behavior Scale worsened significantly for allogeneic BMT patients from two years post-transplant to four years post-transplant (Andrykowski et al., 1989) are contrary to what would be expected. Therefore, this finding does not support the validity of the SIP Alertness Behavior Scale. Findings indicating that the correlation between the POMS Confusion Scale and TBI dose approached significance (Andrykowski et al., 1990) would be expected and provide partial support for the validity of the POMS Confusion Scale. However, findings indicating that scores on the POMS Confusion Scale were stable over time from two years post-transplant to four years post-transplant (Andrykowski et al., 1989) are not what would be expected. Rather, it would be expected that scores would decrease from two years to four years post-transplant. This finding does not support the validity of the POMS Confusion Scale. Evidence regarding the validity of the EORTC-CF is also mixed. Findings indicating that lymphoma patients treated with autologous BMT scored significantly higher on the EORTC-CF than lymphoma patients treated with combination chemotherapy and a group of healthy controls (Hjermstad et al., 1999) would be expected

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6 and, therefore, support the validity of the EORTC-CF. However in the same study, autologous BMT patients reported greater cognitive complaints on the EORTC-CF than allogeneic BMT patients (Hjermstad et al., 1999). This finding is contrary to what would be expected given the better outcomes usually associated with autologous BMT than allogeneic BMT and, therefore, does not support the validity of the EORTC-CF. Also in the same study, EORTC-CF scores were not significantly different for leukemia patients treated with allogeneic BMT, lymphoma patients treated with combination chemotherapy, and a group of healthy controls (Hjermstad et al., 1999). This finding does not support the validity of the EORTC-CF because group differences would be expected between the different treatment groups and the healthy controls. In another study, EORTC-CF scores were not different for localized prostate cancer patients and healthy controls (Joly et al., 1998). Again, it would be expected that prostate cancer patients would score higher on the EORTC-CF than healthy controls and, therefore, the validity of the EORTC-CF is not supported. No significant differences in EORTC-CF scores were found between prostate cancer patients receiving hormonal therapy and prostate cancer patients not receiving hormonal therapy (Green et al., 2002). Group differences would be expected, with prostate cancer patients receiving hormonal therapy reporting greater cognitive complaints than prostate cancer patients not receiving hormonal therapy. Therefore, this finding does not provide support for the validity of the EORTC-CF. Other findings reported in these studies also provide mixed evidence regarding the validity of the cognitive complaint measures. Two studies (Andrykowski et al., 1989, 1990) used two measures of cognitive complaints, the SIP Alertness Behavior Scale and

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7 the POMS Confusion scale. The SIP Alertness Behavior Scale was positively correlated with TBI dose and the POMS Confusion Scale approached significance with TBI dose (Andrykowski et al., 1990), providing partial support for the concurrent validity of the two measures. The correlation between the SIP Alertness Behavior Scale and the POMS Confusion Scale was not reported. Concurrent validity was not supported in another study (Andrykowski et al., 1989), in which the SIP Alertness Behavior Scale detected change over time, while the POMS Confusion Scale remained stable over time. Again, the correlation between the SIP Alertness Behavior Scale and the POMS Confusion Scale was not reported. In the three studies which used the EORCT-CF (Green et al., 2002; Hjermstad et al., 1999; Joly et al., 1998), no other measure of cognitive complaints was used, therefore, concurrent validity is unknown. Convergent validity was not demonstrated in any of the five previously mentioned studies (Andrykowski et al., 1989, 1990; Green et al., 2002; Hjermstad et al., 1999; Joly et al., 1998), as none of the cognitive complaint measures were compared to measures of constructs such as depression, fatigue, anxiety, and health-related quality of life. One study (Green et al., 2002) did look at cognitive complaints, measured by the EORTC-CF, in relation to threat appraisal and coping. As hypothesized by Green et al. (2002), greater threat appraisal was associated with more cognitive complaints. However, contrary to expectations, greater not lesser use, of coping was correlated with higher cognitive complaints. As none of these studies used neuropsychological tests, criterion validity was not examined. Also, none of the studies reported internal consistency for the scales. As the EORTC-CF consists of only two items, internal consistency may be poor.

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8 Review of Cognitive Complaints and Cognitive Functioning Literature In contrast to the studies described previously that assessed only subjective complaints, eight studies can be identified that used a measure of cognitive complaints as well as a neuropsychological test battery to assess cognitive functioning. To measure cognitive complaints, one study used the Medical Outcomes Study (MOS) Cognitive Functioning Scale (Stewart & Ware, 1992), one study used the Squire Memory SelfRating Questionnaire (Squire, Wetzel, & Slater, 1979), one study used the Concentration scale of the Checklist Individual Strength (CIS), the Alertness and Intellectual scales of the SIP, and daily complaints of memory and concentration (Vercoulen et al., 1994), and five studies used the EORTC-CF. Of the five studies that used the EORTC-CF, three also used a checklist of cognitive problems in daily life, and one also used an interviewbased rating by a neuropsychologist to assess cognitive complaints. Klein et al. (2002) used the Cognitive Functioning Scale of the MOS to assess cognitive complaints. The MOS Cognitive Functioning Scale consists of six items adapted from the SIP that assess confusion, concentration and thinking, attention, memory, reasoning, and psychomotor function. Each question is rated on a six-point Likert-type scale (1=All of the time, 2=Most of the time, 3=A good bit of the time, 4=Some of the time, 5=A little of the time, 6=None of the time). The study sample consisted of patients with glioma who had been treated with radiotherapy (N=104), patients with glioma who had not been treated with radiotherapy (N=91), and patients with hematological cancer (N=100). Neuropsychological measures tested the domains of intelligence, perception and psychomotor speed, attention and executive function, and memory. Glioma patients treated with radiotherapy and without radiotherapy reported

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9 significantly lower scores on the MOS Cognitive Functioning Scale than published data on healthy controls, but did not differ from patients with hematological cancer. No difference was found on the MOS Cognitive Functioning Scale between glioma patients treated with or without radiotherapy. Among glioma patients, scores on measures of memory, attention, psychomotor speed, and graphomotor speed were moderately correlated with cognitive complaints ( r = .23, .30, 34, and .31, respectively). Ahles et al. (2002) used the Squire Memory Self-Rating Questionnaire to measure cognitive complaints in cancer patients five years post-treatment. The Squire Memory Self-Rating Questionnaire consists of 18-items rated on a nine-point scale ranging from – 4 (worse than ever before) to +4 (better than ever before). Each item inquires about a different aspect of memory functioning and was derived from remarks the scale developers obtained from patients treated with electroconvulsive therapy. The sample in this study consisted of breast cancer patients treated with chemotherapy (N=35), lymphoma patients treated with chemotherapy (N=36), breast cancer patients treated with local therapy (N=35), and lymphoma patients treated with local therapy (N=22). Each patient was administered neuropsychological tests assessing verbal ability, spatial ability, verbal learning, verbal memory, visual memory, psychomotor function, motor functioning, attention, and attention reaction time. Factor analysis of the Squire Memory Self-Rating Questionnaire yielded three factors: new learning, working memory, and remote retrieval. The factor of working memory was found to be significantly lower for patients treated with chemotherapy than local therapy. The correlation between the factors and the neuropsychological domains were described as generally low and nonsignificant (values not reported).

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10 Servaes, Verhagen, and Bleinjenberg (2002) used three instruments to assess cognitive complaints: the Concentration scale of the CIS, the Alertness and Intellectual scales of the SIP, and a daily record of complaints about memory and concentration. The CIS Concentration scale consists of five items scored on a seven-point Likert scale with higher scores indicating a higher level of concentration problems. To determine daily complaints of memory and concentration, patients were asked to keep a self-observation list for a 12-day period. Memory and concentration problems were rated four times daily (0=No, 1=Yes). Total daily scores ranged from 0 to 4, with high scores indicating more problems with memory and concentration. The sample consisted of 150 breast cancer patients who were divided into two groups, severely fatigued patients (n=57) and nonseverely fatigued patients (n=93). Patients were defined as severely fatigued if they scored 35 or higher on the Fatigue Severity Scale of the CIS. Data were also collected for a control group of 78 friends and family of the breast cancer patients with no history of cancer. Patients were tested six months to five years post-treatment. The treatments patients received consisted of radiotherapy and chemotherapy (N=66), no chemotherapy or radiotherapy (N=20), chemotherapy only (N=33), or radiotherapy only (N=31). Neuropsychological tests assessed reaction time and concentration. With one exception, severely fatigued breast cancer patients reported significantly more problems on all three measures of cognitive complaints than the nonseverely fatigued breast cancer patients and controls. The exception was for daily reports of memory problems, in which no difference was seen between severely and nonseverely fatigued patients. Nonseverely fatigued patients did not differ from controls on any measure of cognitive complaints. No significant differences in cognitive complaints existed between the different treatment

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11 groups. Severely fatigued, nonseverely fatigued, and controls did not differ on neuropsychological tests of concentration. However, for reaction time, group differences did exist. Severely fatigued patients were significantly slower compared to controls, but severely fatigued patients were not significantly different than nonseverely fatigued patients. Nonseverely fatigued patients had slower reaction times than the controls for one of the three reaction time subtests. The lack of differences between severely fatigued patients and nonseverely fatigued patients on a concentration task and a reaction time task are not consistent with the subjective reports, where severely fatigued patients had greater complaints than the nonseverely fatigued patients. Cull, Hay, Love, Mackie, Smets, and Stewart (1996) used the EORTC-CF to measure cognitive complaints in 91 lymphoma patients six months post-treatment. The EORTC-CF was used to divide the sample into complainers (N=25) and non-complainers (N=66), which was defined as rating either question a “3” or a “4”. Neuropsychological measures were used to test intelligence, concentration, and memory. Complainers and non-complainers did not differ significantly on the neuropsychological measures of intelligence, memory, and concentration. No significant difference was found between complainers and non-complainers on ratings of their health and global quality of life, however, complainers had significantly higher scores on measures of anxiety, depression, and fatigue than non-complainers. Van Dam et al. (1998) used the EORTC-CF and a checklist of cognitive complaints in daily life to measure cognitive complaints. The checklist consisted of four questions assessing concentration, memory, thinking, and language. Patients were asked to indicate the extent to which problems in each of these four domains occurred in their

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12 daily life on a five-point Likert scale (0=Not at all, 1=Slightly, 2=Moderately, 3=Quite a bit, 4=Extremely). The sample consisted of 70 patients two years post-treatment who had been randomly assigned to receive high-dose chemotherapy (N=34) or standard-dose chemotherapy (N=36) and a control group of breast cancer patients matched on age and time since treatment who had not received chemotherapy (N=34). Patients were assessed with neuropsychological measures of verbal function, memory, attention/concentration, speed of information processing, motor function, visuoconstructional function, and mental flexibility. An overall score of cognitive impairment (OSCI) was calculated for each patient by counting all tests on which the patient was impaired. Impairment was defined for the chemotherapy groups as scoring two standard deviations below the mean score of the control group on that test. Impairment for the control group was defined as scoring in the fifth percentile of the control patients for that test. On the checklist, the high-dose and standard-dose chemotherapy groups did not significantly differ from each other. Both chemotherapy groups scored significantly higher than the control group for complaints on the checklist items related to concentration, memory, and language. For the EORTC-CF there was no significant difference between the two chemotherapy groups, and only the high-dose chemotherapy group scored significantly higher than the control group. The checklist and the EORTC-CF were significantly correlated with each other. The EORTC-CF and the checklist concentration, memory, and thinking questions were also significantly correlated with measures of anxiety and depression. No relationship existed between either measure of cognitive complaints and the OSCI (range r = -.03 to .08).

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13 Schagen et al. (1999) used the same measures of cognitive complaints as van Dam et al. (1998) to assess breast cancer patients two years post-treatment. The sample in this study consisted of patients who were treated with conventional chemotherapy (N=39) and the control group from the van Dam et al. (1998) study (N=34). These patients received the same neuropsychological measures as in the previously discussed study and impairment was also defined in the same way. On the checklist, the chemotherapy patients reported significantly more complaints in concentration and memory than the control group. No significant group differences existed for the checklist items about thinking and language. Chemotherapy patients scored significantly higher on the EORTC-CF than the healthy controls. Scores on the checklist and on the EORTC-CF were not significantly related to the OSCI or to any of the domain scores of the neuropsychological tests (range r = -.20 to .08). The checklist and the EORTC-CF were significantly correlated with each other and with measures of anxiety and depression. Schagen et al. (2002) reassessed the samples from the van Dam et al. (1998) study and the Schagen et al. (1999) study two years after the initial testing using the same cognitive complaints measures and neuropsychological measures. The sample consisted of three groups: high-dose and standard-dose chemotherapy patients (N=45) from the van Dam et al. study (1998); conventional chemotherapy patients (N=31) from the Schagen et al. study (1999), and the control group used in both previously mentioned studies (N=27). At four years post-treatment there were no significant differences in scores on the checklist and scores on the EORTC-CF among the high-dose group, the standard-dose group, and the control group. Patients in the conventional chemotherapy group reported significantly more cognitive complaints than the control group on the checklist questions

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14 of concentration and memory and on the EORTC-CF. The correlations between cognitive performance and cognitive complaints for all groups were low and nonsignificant (range r =.19-.22). The relationship between the changes in cognitive performance and the changes in cognitive complaints assessed by the checklist was characterized as negligible. Harder et al. (2002) used the EORTC-CF and a rating by a neuropsychologist to measure cognitive complaints in 40 patients who had completed allogeneic BMT 22 to 82 months earlier. Based on an interview, the neuropsychologist rated the extent of the patient’s cognitive problems on a four-point Likert-type scale (0=no problem, 1=mild problems, 2=moderate problems, 3=severe problems). Patients were assessed on neuropsychological measures of general intelligence and conceptual reasoning, verbal function, memory, attention functions and concentration, executive functions, visual spatial and visuoconstructive ability, psychomotor function, and speed of information processing. The EORTC-CF was significantly positively correlated with fatigue. Total neuropsychological impairment, defined as the number of tests the patient scored two standard deviations below healthy population norms, was significantly negatively correlated with the EORTC-CF ( r = -.55). There was no relationship between total neuropsychological impairment and the neuropsychologist’s rating (values not reported). In summary, studies evaluating group differences yield mixed support for the validity of each cognitive complaint measure. For the one study that used the MOS Cognitive Functioning Scale (Klein et al., 2002), glioma patients treated with or without radiotherapy reported significantly greater cognitive complaints in comparison to published data on healthy controls. The finding that glioma patients reported greater

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15 cognitive complaints is consistent with expectations, providing support for the validity of the MOS Cognitive Functioning Scale. However, the MOS Cognitive Functioning Scale did not detect group differences between the glioma patients treated with radiotherapy, the glioma patients treated without radiotherapy, and the patients with hematological cancer. As group differences would be expected, these findings do not support the validity of the MOS Cognitive Functioning Scale. In the one study that used the Squire Memory Self-Rating Questionnaire (Ahles et al., 2002), one of the three factors of the questionnaire (working memory) was significantly lower for breast cancer patients treated with chemotherapy than breast cancer patients treated with local therapy. This finding would be expected and, therefore, supports the validity of the working memory factor of the Squire Memory Self-Rating Questionnaire. However, no group differences were found for the other two factors of new learning and remote retrieval. Taken together, these findings provide very limited support for the validity of this measure. Severely fatigued breast cancer patients were found to score significantly higher on the CIS, SIP Alertness Intellectual scales, and ratings of daily complaints of memory or concentration than nonseverely fatigued breast cancer patients and healthy controls (Servaes et al., 2002). These results are consistent with the expectation that severely fatigued patients would have the most cognitive complaints, and provides support for the validity of the CIS, SIP Alertness Intellectual scales, and ratings of daily complaints of memory or concentration. Findings also indicated that scores on the CIS, SIP Alertness Intellectual scales, and ratings of daily complaints of memory or concentration did not differ between nonseverely fatigued breast cancer patients and healthy controls (Servaes

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16 et al., 2002). However, it would be expected that cancer patients would have greater cognitive complaints and the lack of group differences does not provide support for the three measures. The CIS, SIP Alertness Intellectual scales, and ratings of daily complaints of memory or concentration did not detect significant differences between patients treated with radiotherapy and chemotherapy, no chemotherapy or radiotherapy, chemotherapy only, or radiotherapy only (Servaes et al., 2002). This pattern of results does not support the validity of the CIS, SIP Alertness Intellectual scales, or ratings of daily complaints of memory or concentration, as group differences would be expected due to the different treatments. The checklist of cognitive complaints used in three of the studies (Schagen et al., 1999, 2002; van Dam et al., 1998) yielded mixed results in detecting group differences. In one study, high-dose and standard-dose chemotherapy patients reported more complaints than healthy controls for the three questions assessing concentration, memory and language, but not the fourth question assessing thinking (van Dam et al., 1998). Since it would be expected that cancer patients would have more cognitive complaints than healthy controls, results provide support for the validity of three out of the four questions. Breast cancer patients treated with conventional chemotherapy also reported more complaints about concentration and memory than healthy controls (Schagen et al., 1999), supporting the validity of two out of the four questions. This same sample of breast cancer patients treated with conventional chemotherapy reported greater complaints in concentration and memory than the healthy controls two years later (Schagen et al., 2002), again providing support for the validity of the questions assessing concentration and memory. However, findings indicated that the question assessing

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17 thinking did not yield group differences in all three studies. This is contrary to what would be expected and, therefore, does not support the validity of that question. Findings indicating that the checklist scores did not differ between the high-dose and the standarddose chemotherapy patients (van Dam et al., 1998) suggest that the checklist was unable to detect group differences based on treatment type. A two year follow-up assessment conducted with this sample (Schagen et al., 2002) found no difference in cognitive complaints assessed by the checklist among high-dose patients, standard-dose patients, and healthy controls. Group differences would be expected, and the lack of findings does not support the validity of the checklist. Mixed support was also found for the validity of the EORTC-CF based on the detection of group differences. Findings indicating that scores on the EORTC-CF were higher for patients treated with high-dose chemotherapy than healthy controls (van Dam et al., 1998) support the validity of the EORTC-CF. The EORTC-CF also detected group differences between breast cancer patients treated with conventional chemotherapy and healthy controls at an initial assessment (Schagen et al., 1999) and, again, two years later (Schagen et al., 2002). The ability of the EORTC-CF to detect expected group differences between cancer patients and healthy controls supports the validity of the measure. However, the EORTC-CF did not detect a difference between patients treated with high-dose chemotherapy and patients treated with low-dose chemotherapy (van Dam et al., 1998). It would be expected that patients treated with high-dose chemotherapy would have more cognitive complaints than patients treated with low-dose chemotherapy. Assessments conducted two years later with the same samples of high-dose chemotherapy patients, low-dose chemotherapy patients, and healthy controls found no

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18 group differences in EORTC-CF scores (Schagen et al., 2002). The lack of group differences at this assessment does not support the validity of the EORTC-CF. Mixed support was also obtained for other aspects of validity. Five of the eight studies used multiple measures to assess cognitive complaints. Evidence of concurrent validity was found in three studies (Schagen et al., 1999, 2002; van Dam et al., 1998) in which the EORTC-CF was shown to be significantly correlated with a checklist of cognitive complaints. Three studies demonstrated convergent validity for the EORTC-CF with anxiety and depression (Cull et al., 1996; Schagen et al., 1999; van Dam et al., 1998) and three studies demonstrated convergent validity for the EORTC-CF with fatigue (Cull et al., 1996; Harder et al., 2002; Servaes et al., 2002). Convergent validity for the EORTC-CF with health related quality of life was not supported in one study (Cull et al., 1996) All eight of these studies compared cognitive complaints to cognitive performance. Six studies (Ahles et al., 2002; Cull et al., 1996; Schagen et al., 1999, 2002; Servaes et al., 2002; van Dam et al., 1998) found no significant relation between cognitive complaints and cognitive performance. One study (Klein et al., 2002) found scores for the MOS Cognitive Functioning Scale to be moderately correlated with neuropsychological measures assessing memory, attention, psychomotor speed, and graphomotor speed. Another study (Harder et al., 2002) reported a significant correlation between the EORTC-CF and a composite score for neuropsychological measures. Taken together, these results yield mixed support for the validity of measures currently used to assess cognitive complaints in cancer patients. The general lack of correspondence between measures of cognitive complaints and measures of cognitive

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19 performance is particularly notable. One reason may be that cognitive complaints and neuropsychological functioning have been examined as continuous variables. Their relationship may only be apparent if contrasting groups are used and the relationship of cognitive complaints to impaired versus non-impaired subjects on neuropsychological functioning is examined. The Functional Assessment of Cancer Therapy Cognitive Scale The FACT-Cog is a measure of cognitive complaints that was recently developed by Wagner and colleagues (2002). This instrument was created by first obtaining qualitative data from oncology providers and patients on the perceived impact of chemotherapy on cognitive functioning and associated impairments in quality of life. Next, individual interviews were conducted with oncologists, oncology nurses, and cancer patients. Cancer patients also participated in focus groups. The most commonly described deficits were memory loss and forgetfulness, impaired concentration, wordfinding difficulties, fatigue, and frustration with these deficits. The oncologists and nurses reported that these deficits impair patients’ ability to comprehend medical instructions and adhere to medication regimens. The patients reported that these deficits interfere in social and work functioning (Wagner et al., 2002). Based on these findings, 51 items were created to assess a cognitive domain, an impact on functioning domain, and an impact on quality of life domain. The cognitive domain consists of subscales assessing mental acuity, concentration, verbal and nonverbal memory, and verbal fluency. The impact on functioning domain consists of subscales assessing functional interference due to deficits, others observation of these deficits, and change from previous functioning. The items in the cognitive domains and

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20 impact on functioning domains are rated on a 5-point scale (0=Never, 1=About once a week, 2=Two to three times a week, 3=Nearly every day, 4=Several times a day) of how often each statement had occurred during the past seven days. The eight items assessing impact on quality of life are administered twice. The first time the respondents are asked to rate the items on the 5-point frequency scale described above and the second time the respondents are asked to rate the items on a 5-point severity scale (0=Not at all, 1=A little bit, 2=Somewhat, 3=Quite a bit, 4=Very much). To minimize the impact of distress unrelated to cognitive abilities on responses, the FACT-Cog is primarily composed of behaviorally based items. The scale was evaluated to be between a fifth and sixth grade reading level. Aims The previously discussed literature demonstrates the lack of reliable and valid measures currently available to assess cognitive complaints. The most commonly used measure of cognitive complaints, the EORTC-CF, is of unknown reliability and has yielded mixed evidence of validity. This state of affairs supports the development of a new measure, such as the FACT-Cog. The literature has also demonstrated that a significant portion of BMT patients report cognitive complaints following treatment (Andrykowski et al., 1989, 1990; Harder et al., 2002; Hjermstad et al., 1999; Schagen et al., 2002; van Dam et al., 1998). Patients undergoing a BMT receive high-dose chemotherapy, radiotherapy, or both to deliberately compromise the patient’s immune system. The immune system is subsequently restored though induction of blood or marrow products obtained from the same person (autologous transplantation) or from a

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21 donor (allogeneic transplantation). These characteristics suggest that BMT patients are an important and appropriate sample for the current study. The goal of the current study was to examine the psychometric properties of the FACT-Cog, a newly developed instrument designed to measure perceived cognitive deficits in people with cancer. The first step was to determine internal consistency. To evaluate concurrent validity, scores on the FACT-Cog were compared to scores on an established subjective measure of cognitive deficits, the EORTC-CF. To evaluate convergent validity, scores on the FACT-Cog were compared to scores on established self-report measures of depression (Center for Epidemiological Studies Depression Scale [CES-D]; Radloff, 1977), anxiety (State Version of the State Trait Anxiety Inventory [STAI-S]; Spielberger, Gorsuch, Lushene, Vagg, & Jacobs, 1983), and fatigue (Fatigue Symptom Inventory [FSI]; Hann et al., 1998). Also to evaluate convergent validity, scores on the FACT-Cog were compared to scores on an established measure of healthrelated quality of life (Medical Outcome Study Short From [SF-36]; Ware, Snow, Kosinski, & Gandek, 1993). To evaluate divergent validity, scores on the FACT-Cog were compared to scores on an established self-report measure of extroversion/introversion (NEO Five Factor Inventory Extroversion subscale [NEO-FFI]; Costa & McCrae, 1992a). Finally, to evaluate criterion validity, scores on the FACT-Cog were compared to scores derived from standardized neuropsychological measures. Hypotheses 1. There will be a positive relationship between perceived cognitive deficits as measured by the FACT-Cog and scores on another established subjective measure of cognitive complaints.

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22 It is predicted that the total score on the FACT-Cog will be positively correlated with the total score on the EORTC-CF. 2. There will be a positive relationship between perceived cognitive deficits as measured by the FACT-Cog and depression. It is predicted that the total score on the FACT-Cog will be positively correlated with the total score on the CES-D. 3. There will be a positive relationship between perceived cognitive deficits as measured by the FACT-Cog and anxiety. It is predicted that the total score on the FACT-Cog will be positively correlated with the total score on the STAI-S. 4. There will be a positive relationship between perceived cognitive deficits as measured by the FACT-Cog and fatigue. It is predicted that the total score on the FACT-Cog will be positively correlated with the total score on the FSI Fatigue Disruptiveness Scale. 5. There will be a positive relationship between perceived cognitive deficits as measured by the FACT-Cog and health-related quality of life. It is predicted that the total score on the FACT-Cog will be negatively correlated with the physical component and mental component summary scales of the SF-36. 6. There will be no relationship between perceived cognitive deficits as measured by the FACT-Cog and extroversion-introversion. It is predicted that the total score on the FACT-Cog will not be correlated with the total score on the NEO-FFI Extroversion scale.

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23 7a. There will be a negative relationship between perceived cognitive deficits as measured by the FACT-Cog and standardized neuropsychological measures. It is predicted that the total score on the FACT-Cog will be negatively correlated with the total neuropsychological performance score. If this prediction is supported, exploratory analyses will be conducted to examine relationships between individual subscales of the FACT-Cog and individual cognitive domains from the neuropsychological measures. 7b. Cognitive deficits, as measured by the FACT-Cog, will be greater in patients classified as impaired on neuropsychological performance than in patients classified as non-impaired on neuropsychological performance. It is predicted that the total score on the FACT-Cog will be significantly higher for impaired patients than non-impaired patients. If this prediction is supported, exploratory analyses will be conducted to examine group differences for individual subscales of the FACT-Cog.

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24 Method Participants Participants were men and women currently enrolled in a study titled “Cognitive Function in Patients Undergoing Blood and Marrow Transplantation” at Moffitt Cancer Center. Eligibility criteria for the aforementioned study were: 1) age between 18 and 75 years; 2) completion of at least 8 years of formal education; 3) the ability to speak and read standard English; and 4) acceptance into the Moffitt BMT program. Additional criteria for the current study were that participants in the aforementioned study were returning to Moffitt to receive neuropsychological testing at either a 6-month or 12month follow-up assessment. Procedure Patients who are identified as BMT candidates are routinely scheduled for a psychosocial evaluation comprised of a clinical interview with a social worker and a brief evaluation with a psychologist to identify psychological problems and assess quality of life. From this standard pre-BMT psychosocial evaluation, patients were recruited for the aforementioned BMT study and randomly assigned to one of three neuropsychological testing groups. All participants completed psychosocial measures pre-BMT, 6-months post-BMT, and 12-months post-BMT. Sixty percent of the participants (Group 1) were assessed with the neuropsychological battery pre-BMT, 6-months post-BMT, and 12months post-BMT. Of the remaining 40 percent of participants, 20 percent received the neuropsychological battery 6-months post-BMT and 12-months post-BMT (Group 2), and 20 percent received the neuropsychological battery only at 12-months post-BMT (Group 3). For the current study, data on estimated intellectual ability and extroversion

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25 measured for all participants at the pre-BMT assessment were used. The remaining psychosocial measures and neuropsychological tests were assessed once, at either 6months post-BMT or 12-months post-BMT according to the testing schedule listed above. A trained research assistant administered the neuropsychological battery. The psychosocial questionnaires were given to the participant to complete while at Moffitt or to be taken home and mailed back at the participant’s convenience using a postage paid envelope that was provided. For their participation in the aforementioned BMT study, participants were paid 25 dollars upon completion of each of the post-BMT assessments, regardless of the group to which they were assigned. Measures Demographic, Disease, and Treatment Measures Demographic information was obtained through a background interview. Variables assessed include: date of birth, handedness, race, marital status, income, and education. Electronic medical charts were reviewed to obtain information on cancer type, type of transplant, date of diagnosis, date of admittance, date of transplant, and date of discharge. Psychosocial Measures Perceived Cognitive Functioning. Two instruments were used to assess perceived cognitive functioning: the Functional Assessment of Cancer Therapy Cognitive Scale and the EORTC QLQ-C30 Cognitive Functioning Scale. The Functional Assessment of Cancer Therapy Cognitive Scale (FACT-Cog; Wagner et al., 2002) is a 51-item measure designed to assess subjective perception of cognitive deficits in cancer patients. Items were written based on the most commonly identified themes obtained from focus groups

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26 or individual interviews with oncologists, oncology nurses, and oncology patients. Item formatting is based on the Functional Assessment of Chronic Illness Therapy (FACIT) measurement system. The FACT-Cog yields four summary scores: 1) a cognitive domain score, consisting of mental acuity, concentration, verbal and nonverbal memory, and verbal fluency subscale scores; 2) an impact on functioning domain score, consisting of functional interferences, other people noticed deficits, and change from previous functioning subscale scores; 3) an impact on quality of life domain score; and 4) a total score. Participants respond on a five-point Likert scale (0=Never to 4=Several times a day) how often each statement had occurred in the past seven days. The eight items assessing impact on quality of life are administered a second time where patients respond on a five-point Likert scale (0=Not at all to 4=Very much) the frequency to which they have experienced each item. The psychometric properties of this scale are currently being established. The EORTC QLQ-C30 Cognitive Functioning Scale (EORTC-CF; Aaronson et al., 1993), consists of two items that measure subjective cognitive functioning. Participants respond on a four-point Likert scale the extent to which they have experienced each cognitive complaint in the past week (1=Not at all to 4=Very much). The EORTC QLQ-C30 Cognitive Functioning Scale has demonstrated validity with a sample of bone marrow transplant patients, with scores being correlated with total neuropsychological impairment (r = -.55, p<.001; Harder et al., 2002). Depression. The Center for Epidemiological Studies – Depression (CES-D; Radloff, 1977) is a 20-item measure of depressive symptomotology. The items were selected from a pool of items taken from previously validated depression scales, from the literature, and from factor analytic studies. Respondents indicate on a four-point rating

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27 scale (0= rarely or none of the time, 3= most or all of the time) the extent to which they experienced each depressive symptom during the past week. The CES-D has good internal consistency with alphas of .85 for the general population and .90 for a psychiatric population (Radloff, 1977). The validity of the CES-D has been demonstrated with a wide range of populations, including cancer patients (Beeber, Shea, & McCorkle, 1998; Hann, Winter, & Jacobsen, 1999). Anxiety The State form of the State-Trait Anxiety Inventory (STAI-S; Spielberger et al., 1983) is a 20-item inventory that measures the level of current anxiety. Participants respond on a four-point Likert scale (1=Not at all to 4=Very much so) the extent to which they endorse each item. The internal consistency of the instrument ranges from .86 to .95 across male and female samples (Spielberger et al., 1983). The STAI-S has validity correlations of .80 with other established anxiety measures (Spielberger et al., 1983). Fatigue. The Fatigue Symptom Inventory (FSI; Hann et al., 1998) is a 14-item inventory designed to assess the frequency and severity of fatigue as well as its perceived disruptiveness. Frequency is measured as the number of days in the past week (0-7) respondents felt fatigued as well as on average, the extent they felt fatigued each day (0=None to 10=Entire day). Severity is measured on a separate 11-point scale (0=Not at all fatigued to 10=As fatigued as I could be) that assess most, least, and average fatigue during the past week as well as current fatigue. Perceived disruptiveness is measured on a separate 11-point scale (0=No interference to 10=Extreme interference) that assess the degree to which fatigue in the past week was judged to interfere with general level of activity, ability to bathe and dress, normal work activity, ability to concentrate, relations

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28 with others, enjoyment of life, and mood. The interference ratings can also be summed to obtain a total disruptiveness score. Previous research has demonstrated the reliability and validity of the FSI with individuals diagnosed with cancer (Hann et al., 1998). Health-Related Quality of Life. The Medical Outcome SF-36 Health Survey (SF36; Ware et al., 1993) is a 36-item measure of various aspects of perceived health, functioning, and quality of life. It contains eight subscales that measure the extent to which health status impacts each of the following areas; 1) physical functioning; 2) role functioning-physical; 3) bodily pain; 4) general health; 5) vitality; 6) social functioning; 7) role functioningemotional; and 8) mental health. The SF-36 also yields two summary scores that measure global physical functioning (physical component summary scale) and global mental health functioning (mental component summary scale). The items use Likert-type scales, some with five or six points and others with two or three points. Correlations ranging from .52 to .78 have been reported between the SF-36 subscales and other QOL measures (Ware & Sherbourne, 1992; McHorney, Ware, & Raczek, 1993). Test-retest reliability coefficients range from .68-.93 for the various subscales. The SF-36 has been found to have acceptable reliability and validity when administered to healthy and chronically ill individuals (Ware et al., 1993). Extroversion and Neuroticism. The Neuroticism, Extroversion, and Openness – Five-Factor Inventory (NEO-FFI; Costa & McCrae, 1992a) is a 60-item personality measure based on the five-factor model of personality. The five factors assessed are Neuroticism, Extroversion, Openness, Agreeableness, and Conscientiousness. Responses are made on a five-point scale ranging from strongly disagree to strongly agree. Factor analyses have provided support for these factors with coefficient alphas for the five

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29 domain scores ranging from .86 to .95 and test-retest coefficients ranging from .63 to .81 (Costa & McCrae, 1992b, c). For the purpose of this study, only the Extroversion and Neuroticism scales were examined. Neuropsychological Measures Estimated Intellectual Functioning. The National Adult Reading Test (NART; Nelson, 1982) contains 50 irregular words that cannot be easily phonetically decoded. Inter-rater reliability is high ranging from .96 to .98 and test-retest reliability is high at .98 (Crawford, Parker, Stewart, Besson, & De Lacey, 1989). Previous studies have shown that performance on the NART is highly correlated with the general factor of intelligence ‘g’ from the Wechsler scales (Crawford et al., 1989). Attention. The Conners’ Continuous Performance Test (CPT-II; Conners, 2000) is a measure of sustained attention administered on the computer. Participants monitor a random series of single numbers or letters, which are presented continuously. They are asked to indicate that they have detected a target event by pressing the space bar while avoiding responding to distracting stimuli. The CPT-II yields three scores: impulsivity, vigilance, and inattention. Test-retest reliability is high at .92 and validity of the CPT-II has been demonstrated with neurological, clinical, and nonclinical populations (Conners, 2000). Memory. Memory was assessed using three measures: the California Verbal Learning Test; the Logical Memory subtest from the Wechsler Memory Scale-III (WMSIII); and the Visual Reproduction subtest from the WMS-III. The California Verbal Learning Test (CVLT; Delis, Kramer, Kaplan, & Ober, 1987) assesses verbal learning and memory. The test consists of five presentations and recall of a 16-item list of words

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30 belonging to four semantic categories. An interference list of 16-items containing eight words from two shared semantic categories is presented, followed by free recall and a category-cued recall of the original list. Retention is tested 20 minutes after learning by free recall, category-cued recall, and recognition. Split-half reliability and coefficients alpha are in the moderate to high range (Delis et al., 1987). The CVLT correlates well with other measures of memory and learning (Spreen & Strauss, 1998). The Logical Memory subtest from the WMS-III (Wechsler, 1997) assesses memory for prose. Two short stories are read aloud to the participant followed by immediate and delayed recalls and a recognition paradigm. Internal consistency assessed by split-half reliability ranges between .67 and .80 and the inter-scorer reliability coefficient is .99 (Wechsler, 1997). The Visual Reproduction subtest from the WMS-III (Wechsler, 1997) assesses nonverbal memory for designs. Five novel designs are each presented individually for 10 seconds, and the participant is asked to reproduce the design from memory. After a 30 minutes, delayed recall and recognition paradigm are performed. Reliability coefficients for immediate recall and delayed recall are .59 and .46. Inter-scorer reliability is reported at .97 (Wechsler, 1997). Executive Functioning. Executive functioning was assessed using four instruments: 1) Wechsler Adult Intelligence Scale-Revised (WAIS-R) Digit Symbol, 2) Trail Making Test, 3) Controlled Oral Word Association, and 4) Stroop Neuropsychological Screening Test. The WAIS-R Digit Symbol (Wechsler, 1981) is a test of sustained attention, psychomotor speed, and motor persistence. It requires participants to match numbers with a geometric mark according to a designated code. It is consistently noted to be the most sensitive Wechsler subtest to brain dysfunction

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31 (Lezak, 1995). Test-retest reliability ranges from .82-.86 for adults (Wechsler, 1997). It has been shown to be a sensitive indicator of cognitive changes in BMT candidates (Ahles, Tope, Furstenberg, Hann, & Mills, 1996). The Trail Making Test (TMT; Reitan & Wolfson, 1993) assesses the participant’s ability to follow a simple number sequence (Trails A) and their ability to follow a complex sequence of alternating numbers and letters (Trails B). Extensive reliability data are presented in Spreen and Strauss (1998), including reliability coefficients of .69 to .94 for Trail A, and .66 to .86 for Trail B. Strong validity of the TMT as an indicator of mild to severe cognitive dysfunction has been reported with Trails B more sensitive to deficits (Reitan, 1958). The TMT has been shown to be sensitive to BMT treatment effects (Andrykowski et al., 1992). The Controlled Oral Word Association (COWA) from the Multilingual Aphasia Examination (Benton & Hamsher, 1989) assesses the speed and ease of word production and is a measure of executive function (e.g., initiation, perseveration and effortful output). Participants are asked to generate as many words as possible beginning with a target letter provided by the examiner over a one-minute trial. There are three trials and respondents are requested to not use proper nouns or the same words with different suffixes. Inter-scorer reliability is excellent, and test-retest reliability ranges from .70 to .88, as reported in Spreen & Strauss (1998) who also report strong concurrent validity. The COWA has been shown to be a sensitive measure with BMT candidates (Ahles et al., 1996). The Stroop Neuropsychological Screening Test (Stroop; Trenarry, Crosson, DeBoe, & Leber, 1989) is a task of effortful attention and speed and is sensitive to subtle attentional deficits (Lezak, 1995; Spreen & Strauss, 1998). The Stroop consists of two trials: one in which the subject reads the words printed on a page and one in which the

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32 subject names the color of the ink that the word is printed in. Test-retest reliability is high (.90) and validity data indicate that the Stroop can discriminate cognitively impaired groups from normal groups (Trenarry et al., 1989). Motor. The Grooved Pegboard (Matthews & Klove, 1964) evaluates speeded manual dexterity. It requires the participants to place ridged pegs in a 5 X 5 square array with slots that are at various orientations requiring rotation of the pegs for correct placement. This level of complexity makes this task sensitive to general psychomotor slowing caused by medication and disease effects (Lezak, 1995). Fatigue and treatment with BMT have been shown to negatively impact the time to complete this task (Andrykowski, 1992). Data Reduction In order to avoid Type I statistical errors, the 22 test scores generated from these measures were grouped into the following four cognitive domains as suggested by Lezak (1995): Attention (CPT); Memory (CVLT, Logical Memory, Visual Reproduction); Executive Functioning (Digit Symbol, TMT, COWA, Stroop); and Motor (Grooved Pegboard). To accomplish this, raw scores were converted into z-scores according to published normative data (Heaton, 1992; Heaton, Grant, & Matthews, 1991; Spreen and Strauss, 1998; Wechsler, 1997) and then averaged according to domain. A total neuropsychological performance index was computed for each subject by deriving the average z-score from the 22 measures.

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33 Statistical Analyses Descriptive statistics (mean and standard deviations) were used to characterize the demographic, disease, and treatment characteristics of the sample. Cronbach alpha coefficients were calculated to evaluate internal consistency of the total score and domain scores of the FACT-Cog. Prior to conducting the main analyses, exploratory analyses were conducted to examine the relationship of demographic and clinical variables to the FACT-Cog total score and domain scores. To test the first hypothesis, a correlational analysis was performed to compare the total score of the FACT-Cog with the total score on the EORTC-CF. A correlational analysis was also performed to compare the FACT-Cog domain scores with the total score on the EORTC-CF. To test the second hypothesis, a correlational analysis was performed to compare the total score of the FACT-Cog with the total score on the CESD. A correlational analysis was also performed to compare the FACT-Cog domain scores with the total score on the CES-D. To test the third hypothesis, a correlational analysis was performed to compare the total score of the FACT-Cog with the total score on the STAI-S. A correlational analysis was also performed to compare the FACT-Cog domain scores with the total score on the STAI-S. To test the fourth hypothesis, a correlational analysis was performed to compare the total score of the FACT-Cog with the total score on the FSI Fatigue Disruptiveness Scale. A correlational analysis was also performed to compare the FACT-Cog domain scores with the total score on the FSI Fatigue Disruptiveness Scale. To test the fifth hypothesis, a correlational analysis was performed to compare the total score of the FACT-Cog with the physical component and mental component summary scales of the SF-36. A correlational analysis was also

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34 performed to compare the FACT-Cog domain scores with the physical and mental component summary scales of the SF-36. Additional correlational analyses were performed to compare the FACT-Cog total score and domain scores with the total score on the NEO-FFI Neuroticism scale. To test the sixth hypothesis, a correlational analysis was performed to compare the total score of the FACT-Cog with the total score on the NEO-FFI Extroversion scale. A correlational analysis was also performed to compare the FACT-Cog domain scores with the total score on the NEO-FFI Extroversion scale. To test the first part of the seventh hypothesis, a correlational analysis was performed to compare the total score of the FACT-Cog with the total neuropsychological performance score. A correlational analysis was also performed to compare the FACT-Cog domain scores with the total neuropsychological performance score. Correlational analyses were performed to compare the FACT-Cog total score and domain scores to the neuropsychological domain scores and individual test scores. To test the second part of the seventh hypothesis, a correlational analysis was performed to compare the total score of the FACT-Cog for the patients classified as impaired and non-impaired on total neuropsychological performance. A correlational analysis was also performed to compare the FACT-Cog domain scores for patients classified as impaired and nonimpaired on total neuropsychological performance. Classification as impaired on total neuropsychological performance was defined as obtaining a z-score at or below –1.5 on three or more neuropsychological tests, similar to the definition used by Schagen et al. (2002). Correlational analyses were performed to compare the FACT-Cog total score and domain scores for patients classified as impaired on neuropsychological domain scores and individual test scores. Performance on individual domains was classified as

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35 impaired if the mean z-score for the domain was at or below –1.5 or at least 50 percent of the z-scores comprising that domain were at or below –1.5 (Lezak, 1995). Performance on individual test scores were classified as impaired if the z-score was at or below –1.5. In addition, multivariate analyses were conducted. A multiple regression analysis was conducted for the FACT-Cog total score. Demographic variables that were significantly correlated with the FACT-Cog total score were entered into the equation first. Psychosocial variables that were significantly correlated with the FACT-Cog total score were then entered into the equation using a forward selection technique with a p < .05 selection criterion. Multiple regression analyses were also conducted for each FACTCog domain score using the same procedure. A uniqueness index was calculated for each variable in the regression analyses by subtracting the variance accounted for by all the variables without the target variable from the total variance accounted for by all of the variables. In order to determine the necessary sample size for correctional analyses, a power analyses was conducted. With 81 participants (p < .05, two-tailed), there was power of .80 to detect a correlational coefficient of .30 (medium effect size; Cohen, 1988).

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36 Results A total of eighty-two participants completed the six-month or twelve-month follow-up assessment. Participants ranged in age from 23 to 72 years old (M = 52.91; SD = 12.03) with a similar number of males (N = 42) and females (N = 40). Education ranged from 8 to 23 years (M = 13.76; SD = 2.30) and estimated IQ (NART scores) ranged from 80 to 124 (M = 98.5; SD = 15.3). A majority of these individuals were Caucasian (85%), married (79%), had received autologous stem cell transplantation (85.4%), and had been diagnosed with multiple myeloma (72%). Approximately 49% of participants reported an annual household income of at least $40,000, 28% were working full-time, and 21% reported not working due to disability. See Table 1 for complete demographic information and Table 2 for complete clinical characteristics. Relationship of FACT-Cog to Demographic Characteristics Exploratory analyses were conducted to determine the relationship between demographic variables and the FACT-Cog total score (see Table 3). Gender was significantly associated with the total score, indicating that women had greater cognitive complaints (p < .01). Age, estimated IQ, years of education, race, marital status, diagnosis, type of transplant, and time since transplant (6 month or 12 month follow-up) were not significantly correlated with the total score (p values > .05). Internal consistency of the FACT-Cog total score was high ( = .983), demonstrating the reliability of the measure. Exploratory analyses were also conducted with each of the FACT-Cog domain scores. Gender was significantly associated with the cognitive

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37 domain, interference of functioning domain, and quality of life domain (p values < .05). Estimated IQ was significantly correlated with the quality of life domain (p < .05). Age, years of education, race, marital status, diagnosis, type of transplant, and time since transplant were not significantly correlated with any of the domain scores (p values > .05). Internal consistency was high for the cognitive domain ( = .962), the interference of functioning domain ( = .959), and the quality of life domain ( = .957). The FACTCog domain scores were highly correlated with each other. The highest correlation was between the cognitive domain and the interference of functioning domain (r = .92, p < .0001), followed by the interference of functioning domain and quality of life domain (r = .84, p < .0001). The lowest correlation was between the cognitive domain and the quality of life domain (r = .78, p < .0001). Relationship of FACT-Cog to Psychosocial Variables As hypothesized, the FACT-Cog total score was significantly correlated with the EORTC-CF supporting the concurrent validity of the measure (r = .66, p <.0001). The FACT-Cog cognitive, interference of functioning, and quality of life domain scores were also significantly correlated with the EORTC-CF. (r = .65, .68, and .57 respectively, p values < .0001). To test the convergent validity of the FACT-Cog, hypothesized relationships between the total score and psychosocial variables were tested. As expected (see Table 4), the FACT-Cog total score was significantly correlated with measures of depression, fatigue, anxiety, mental well-being, and physical well-being (p values < .01). All three domain scores were also significantly correlated with measures of depression, fatigue, anxiety, mental well-being and physical well-being (p values < .05).

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38 To assess divergent validity, the correlations of the FACT-Cog with extroversion, as measured by the NEO Personality Inventory, were examined. Consistent with expectations, the FACT-Cog total score was not significantly correlated with extroversion (p > .05). The cognitive domain score and the quality of life domain score were also not significantly correlated with extroversion (p > .05), however, the interference of functioning domain score was significantly correlated with extroversion (p < .05). The relationship of neuroticism with the FACT-Cog was also examined. The FACT-Cog total score, cognitive domain score and interference of functioning domain score were significantly correlated with neuroticism (p < .05). The quality of life domain score was not significantly correlated with neuroticism (p >.05). An exploratory regression analysis was conducted to determine the relative contribution of psychosocial variables to the total variance of the FACT-Cog total score (see Table 5). To control for the contribution of gender, which was significantly related to the FACT-Cog total score (p < .05), it was entered first. After controlling for gender, the psychosocial variables that were significantly correlated with the total score in univariate analyses were entered into the equation using the forward selection technique with a p < .05 selection criterion. Gender accounted for 9% of the variance in the FACTCog. Fatigue entered the model on the second step and accounted for 23% of the remaining variance (p < .0001). The final variable to enter the model was mental wellbeing, which accounted for 5% of the remaining variance (p < .05). Together, these variables accounted for 37% of the total variance in the FACT-Cog. Physical well-being, anxiety, neuroticism and depression did not account for significant additional variance.

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39 Regression analyses were also conducted for each FACT-Cog domain score using the previously described method. For the cognitive domain (see Table 6), gender was entered into the equation first and accounted for 9% of the variance. Mental well-being entered into the equation next accounting for 18% of the remaining variance (p < .0001). Together, these variables accounted for 27% of the total variance in the FACT-Cog cognitive domain. Fatigue, neuroticism, anxiety, depression, and physical well-being did not account for significant additional variance. For the interference of functioning domain (see Table 7), gender was controlled for and accounted for 10% of the variance. Mental well-being entered into the equation next accounting for 22% of the remaining variance (p < .0001). Together, these variables account for 32% of the total variance in the FACT-Cog interference of functioning domain. Fatigue, extroversion, anxiety, depression, and physical well-being did not account for significant additional variance. For the quality of life domain (see Table 8), gender and IQ were entered into the equation first and accounted for 10% of the variance. Fatigue entered into the equation next accounting for 26% of the remaining variance (p < .0001). Together, these variables account for 36% of the total variance in the FACT-Cog quality of life domain. Mental well-being, anxiety, depression, and physical well-being did not account for significant additional variance. A uniqueness index was calculated to determine the variance accounted for that is unique to each variable. For the total score (see Table 5), gender contributed the largest amount of unique variance (4%) followed by fatigue (3%) and mental well-being (2%). Neuroticism and anxiety each accounted for 1% of unique variance. Depression and physical well-being each accounted for less than 1% of unique variance in the FACT-Cog

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40 total score. For the cognitive domain score (see Table 6), gender and neuroticism each contributed the largest amount of unique variance (4%) followed by anxiety (2%). Mental well-being, fatigue, and depression each accounted for 1% of unique variance, and physical well-being accounted for less than 1% of unique variance. For the interference of functioning domain (see Table 7), gender contributed the largest amount of unique variance (5%) followed by mental well-being (4%). Fatigue and extroversion each contributed 2% of unique variance and anxiety contributed 1% of unique variance. Physical well-being and depression each contributed less than 1% of unique variance. For the quality of life domain (see Table 8), fatigue contributed the most unique variance (3%). Gender and mental well-being each contributed 1% of unique variance. Estimated IQ, depression, physical well-being, and anxiety each accounted for less than 1% of unique variance. Relationship of FACT-Cog to Neuropsychological Variables Contrary to expectations, the FACT-Cog total and domain scores were not significantly related to the total neuropsychological performance score (see Table 9). The lack of significant findings may be a result of a decrease in sensitivity due to the averaging of multiple tests assessing different aspects of cognitive functioning. Therefore, exploratory analyses were conducted to correlate the FACT-Cog with the neuropsychological domain scores and individual test scores (see Tables 9 and 10). The FACT-Cog total and domain scores were not significantly correlated with the four domain scores (memory, executive functioning, motor, and attention). With regards to individual test scores, a significant correlation was found between the quality of life domain score and the vigilance subscale of the CPT-II (p < .05), with higher cognitive

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41 complaints being related to lower vigilance. All other correlations between the FACTCog total and domain scores and the individual neuropsychological test scores were nonsignificant. To determine if patients with greater cognitive complaints had greater impaired performance on neuropsychological tests (see Table 11), neuropsychological test scores were dichotomized into impaired or non-impaired based on the previously described criterion. The FACT-Cog total and domain scores were not significantly correlated with impairment classification based on the total neuropsychological performance score. As previously mentioned, these results may be a related to of loss of sensitivity, therefore exploratory analyses were conducted. The FACT-Cog total and domain scores were not significantly correlated with the four neuropsychological domain scores (see Table 11). When individual neuropsychological test scores were examined, significant correlations did arise with the CPT-II subscales with higher cognitive complaints associated with impaired performance (see Table 12). Impaired performance on the CPT-II impulsivity subscale was significantly correlated with the FACT-Cog total score and the three domain scores (p < .05). The FACT-Cog total score and quality of life domain score were also significantly correlated with the CPT-II vigilance subscale (p < .05). The direction of these relationships is for impaired performance to be associated with more cognitive complaints. In addition, the FACT-Cog cognitive domain score was significantly correlated with the short delay cued recall score and the long delay free recall score of the CVLT (p < .05). The direction of this relationship is for impaired performance to be associated with fewer cognitive complaints.

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42 To better understand the results, the rates of impairment were examined. The Grooved Pegboard (dominant and nondominant hand) had the highest rates of impairment of individual tests (26.8% and 31.7% respectively). The COWA had the next highest rate at 13.4%. For all of the other individual tests, the percentage of scores classified as impaired ranged from 8.5% to 1.2%. Rate of impairment in the domain scores were also low, except for the motor domain which had the highest impairment rate at 37.8%. The memory domain and the executive functioning domain each had an impairment rate of 3.7%. The attention domain had the lowest rate of impairment at 2.4%. Relationship of EORTC-CF to Demographic Variables Parallel analyses were performed to study the relationship of the EORTC-CF and the demographic, psychosocial, and neuropsychological variables. The EORTC-CF was significantly related to gender (p = .04), with women having greater cognitive complaints, type of transplant (p = .01), with patients who received an autologous transplantation having greater cognitive complaints than patients who received an allogeneic transplantation, and race (p = .05), with Caucasians having more cognitive complaints than non-Caucasians (see Table 3). Age, estimated IQ, years of education, marital status, diagnosis, and time since transplant were not significantly correlated with the EORTC-CF (p values > .05). The EORTC-CF had strong internal consistency ( = .77). Relationship of the EORTC-CF to Psychosocial Variables The EORTC-CF was significantly correlated with depression, fatigue, anxiety, mental well-being, and physical well-being (p values < .001; see Table 3). The EORTC-

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43 CF was also significantly correlated with extroversion (p < .001), but not with neuroticism (p >.05; see Table 3). A regression analysis was conducted with the EORTC-CF to examine which psychosocial variables accounted for a significant amount of the variance (see Table 13). Type of transplant, gender, and race were significantly correlated with the EORTC-CF in univariate analyses, therefore, these three variables were controlled for by being entered into the equation first. Next, the psychosocial factors were entered using a forward selection technique with a p < .05 selection criterion. Type of transplant, gender, and race accounted for 16% of the variance in the EORTC-CF. Mental well-being entered the model in the second step accounting for 20% of the remaining variance (p < .0001). Together, these variables account for 37% of the total variance in the EORTC-CF. Physical well-being, extroversion, fatigue, anxiety, and depression did not account for significant additional variance. A uniqueness index was calculated to determine the amount of unique variance each psychosocial variable contributed (see Table 13). Type of transplant accounted for the most unique variance (6%), followed by extroversion (3%). Gender, race, and mental well-being each accounted for 2% of unique variance in the EORTC-CF. Fatigue accounted for 1% of unique variance and physical well-being, anxiety, and depression each accounted for less than 1% of unique variance. Relationship of the EORTC-CF to Neuropsychological Variables The EORTC-CF was not significantly correlated with the total neuropsychological performance score (see Table 9). As previously stated, the lack of significant findings may be a result of a decrease in sensitivity due to the averaging of

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44 multiple tests. Exploratory analyses found that the EORTC-CF was not significantly correlated with the four neuropsychological domain scores (see Table 9). With regards to individual test scores (see Table 10), the EORTC-CF was significantly correlated with the impulsivity subscale of the CPT-II (p < .05). The direction of this relationship is for impaired performance to be associated with more cognitive complaints. The EORTC-CF was correlated with neuropsychological tests scores that were classified as impaired or non-impaired, based on previously described criterion, to determine if patients with greater complaints had greater impaired performance (see Table 11). The correlations between the EORTC-CF and impairment classification of the total score were nonsignificant. This finding may be a result of lack of sensitivity, therefore exploratory analyses were conducted. No significant correlations were found between the EORTC-CF and impairment of any domain scores (see Table 11). When looking at individual test scores (see Table 12), the EORTC-CF was significantly positively correlated with impairment classification for the delayed visual reproduction score (p < .05), the inattention subscale of the CPT-II (p < .05), and the impulsivity subscale of the CPT-II (p < .01). The direction of these relationships is for impaired performance to be associated with more cognitive complaints.

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45 Discussion The aim of the current study was to examine the psychometric properties of the FACT-Cog, a recently developed instrument designed to measure perceived cognitive deficits in people with cancer. The following section will first evaluate the reliability and validity of the FACT-Cog. Second, additional demographic and multivariate analyses conducted will be reviewed. Next, the FACT-Cog will be compared with the EORTCCF, an established measure of cognitive complaints. Finally, limitations of this study, clinical implications, and future directions for research will be discussed. Reliability The reliability of the FACT-Cog total score was strong, as evidenced by its high internal consistency. The FACT-Cog cognitive, interference of functioning, and quality of life domain scores also demonstrated high internal consistency. Test-retest reliability was not evaluated and thus remains unknown. Concurrent Validity As hypothesized, the FACT-Cog total score was significantly correlated with the EORTC-CF. This significant relationship with an established measure of cognitive complaints provides support for the concurrent validity of the FACT-Cog total score. The concurrent validity of the three FACT-Cog domain scores was also supported by their significant relationships with the EORTC-CF.

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46 Convergent Validity As hypothesized, the FACT-Cog total score was significantly correlated with measures of depression, fatigue, anxiety, mental well-being, and physical well-being. These findings provide evidence for the convergent validity of the FACT-Cog. The same pattern of results was found for the FACT-Cog domain scores. Additional analyses were conducted to examine the relationship of neuroticism to the FACT-Cog total and domain scores. Although no a priori hypothesis about this relationship was made, previous research has found that people with cancer who are high on neuroticism often report worse psychosocial outcomes (Aarstad, Aarstad, Birkhaug, Bru, & Olofsoon, 2003). Therefore, it would be expected that patients high on neuroticism would have greater cognitive complaints. Results for the FACT-Cog total score and cognitive domain and interference of functioning domain scores supported this expectation. The FACT-Cog quality of life domain score, however, was not significantly correlated with neuroticism. These results are consistent with previous research that has found cognitive complaints to be significantly related to psychosocial factors. More specifically, the significant relationship between depression and cognitive complaints was found in research with cancer patients by Cull et al. (1996), Schagen et al. (1999), and van Dam et al. (1998) using other cognitive complaints measures. The results of this study, regarding the relationship of fatigue and cognitive complaints, were also consistent with previous research with cancer patients (Cull et al., 1996; Harder et al., 2002; Servaes et al., 2002). The significant relationship between anxiety and cognitive complaints in this study is consistent with the previous cancer research as well (Cull et al., 1996; Schagen et al.,

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47 1999; Van Dam et al., 1998). Previous research has not looked specifically at relationship with measures of mental well-being and physical well-being. Although the FACT-Cog was significantly correlated with measures of depression and fatigue, the FACT-Cog shared only 25% of its variance with depression and 28% of its variance with fatigue. This suggests that cognitive complaints is a distinct construct from depression and fatigue. Divergent Validity As hypothesized, the FACT-Cog total score was not correlated with a measure of extroversion. This finding reflects the expected pattern for divergent validity. There was mixed support for the divergent validity of the FACT-Cog domain scores. As expected, the cognitive and quality of life domains were not significantly correlated with extroversion, however, the interference of functioning domain was significantly correlated with extroversion. Previous research has not examined the divergent validity of cognitive complaints measures. This is the first study to examine the relationship of cognitive complaints to extroversion to assess divergent validity. Previous research has not found a significant relationship between extroversion and depression (Van der Zee, Buunk, Sanderman, Botke, & Van der Bergh, 1999), or between extroversion and quality of life (Aarstad et al., 2003) in cancer patients. Criterion Validity Hypotheses regarding the criterion validity of the FACT-Cog were generally not supported. Contrary to predictions, the FACT-Cog total and domain scores were not significantly related to the total and domain scores for the neuropsychological measures.

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48 Likewise, when the neuropsychological total and domain test scores were dichotomized as impaired or nonimpaired, no significant relationships were found with the FACT-Cog scores. To rule out the possibility that the lack of significant findings may have been related to a loss of sensitivity due to the averaging of multiple tests assessing different aspects of cognitive performance, the relationship of the FACT-Cog total and domain scores to individual neuropsychological test scores was also examined. These analyses did yield a limited number of significant findings. The FACT-Cog quality of life domain was significantly correlated with continuous scores on the vigilance subscale of the CPTII. When neuropsychological performance was classified as impaired or nonimpaired, the impulsivity subscale of the CPT-II was significantly correlated with the FACT-Cog total score and all three FACT-Cog domain scores. The vigilance subscale was significantly correlated with the FACT-Cog total score and quality of life domain score. In all of these instances, poorer performance on the CPT-II was associated with greater cognitive complaints. The short delay cued recall and the long delay free recall subscales of the CVLT test in the memory domain were also significantly related to the FACT-Cog cognitive domain score. In this instance, better performance on the CVLT was associated with greater cognitive complaints. Of note, few participants had impaired performance on the neuropsychological tests. However, the increased number of significant relationships when the scores are dichotomized suggests that there are subcategories of cognitive performance. Although no other correlations between the FACT-Cog and neuropsychological test scores were significant, tests in the memory domain and motor domain had small to medium effect

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49 sizes for correlational analyses (r = .15 to .19) as suggested by Cohen (Cohen, 1987). This suggests that there may be a power issue, in that the sample size was too small to detect significant findings of these more subtle effects. In general, the lack of significant correlations between cognitive complaints and cognitive performance found in this study is consistent with the literature on cancer patients. Ahles et al. (2002) found that correlations between neuropsychological domain scores and cognitive complaints were nonsignificant. Van Dam et al. (1998) and Schagen et al. (1999, 2002) also found no significant relationship between cognitive complaints and neuropsychological total and domain scores. Two studies that examined the relationship between cognitive complaints and individual neuropsychological test scores have also reported nonsignificant relationships (Cull et al., 1996; Servaes et al., 2002). However, Klein et al. (2002) did find significant correlations between cognitive complaints and individual test scores measuring memory, attention, psychomotor speed, and graphomotor speed. Only one study reported results generally inconsistent with the current study’s findings. Harder et al. (2002) reported a significant correlation between cognitive complaints as measured by the EORTC-CF and a total neuropsychological impairment performance score. With regards to criterion validity, the FACT-Cog cannot be considered superior to existing measures of cognitive complaints. Demographic and Multivariate Analyses When examining the relationship of the FACT-Cog total and domain scores to demographic variables, all FACT-Cog scores were significantly correlated with gender, with women having more cognitive complaints than men. The FACT-Cog quality of life domain score was also significantly related to estimated IQ, with higher estimated IQ

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50 associated with greater complaints. The FACT-Cog total and domain scores were not significantly related to age, years of education, race, marital status, diagnosis, type of transplant, and time since transplant. The significant relationship between cognitive complaints and gender has not been found in previous research with cancer patients. Few studies have reported testing for gender differences, but ones that did found no significant relationship between cognitive complaints and gender (Andrykowski et al., 1990; Cull et al., 1996; Hjermstad et al., 1999). However, women have been found to report higher levels of neuroticism than men (Goodwin & Gotlib, 2004), and since neuroticism has been associated with more subjective health complaints in cancer patients (Aarastad et al., 2003), women may be expected to have more cognitive complaints than men. One study found that cognitive complaints were related to years of education (Andrykowski et al., 1990), however, another study found no such relationship (Cull et al., 1996). Consistent with this study, cognitive complaints were not significantly related to age in two studies (Andrykowski et al., 1990 & Cull et al., 1996). Cull et al. (1996) also found that cognitive complaints were not significantly related to estimated IQ, which is consistent with the findings for the FACT-Cog total score and cognitive and interference of functioning domain scores. The current study found no significant difference between types of BMT. This finding is inconsistent with one study that found patients who received autologous BMT had more complaints that patients who received allogeneic BMT (Hjermstad et al., 1999), but is consistent with other research that found so significant differences between different types of treatment groups (Cull et al., 1996; Schagen et al., 2002; Van Dam et al., 1998).

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51 Regression analyses were conducted, controlling for significant demographic variables, to determine which psychosocial variables accounted for a significant amount of the variance in the FACT-Cog total score and domain scores. Only fatigue and mental-well being accounted for a significant amount of the remaining variance in the FACT-Cog total score after controlling for gender. For the FACT-Cog cognitive and the interference of functioning domain scores, only mental well-being accounted for a significant amount of the remaining variance after controlling for gender. For the FACTCog quality of life domain score, only fatigue accounted for a significant amount of the remaining variance after controlling for gender and estimated IQ. Fatigue and mental well-being were the only two psychosocial factors that contributed a significant amount of additional variance in the FACT-Cog total score and domain scores. However, the small uniqueness index for all of the variables in the regression analyses indicates that there was significant overlap in the contributions of each variable. FACT-Cog Total Score in Comparison to the EORTC-CF The FACT-Cog was designed to be a comprehensive measure of cognitive complaints. Therefore, the psychometric properties of the FACT-Cog total score were compared to an established measure of cognitive complaints, the EORTC-CF. Both measures demonstrated adequate internal consistency reliability, however, the FACT-Cog total score had a slightly higher internal consistency than the EORTC-CF (.98 vs. .77). The FACT-Cog total score and EORTC-CF provided equally strong evidence for convergent validity. Both were significantly correlated with measures of depression, fatigue, anxiety, mental well-being and physical well-being. While the FACT-Cog total

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52 score demonstrated divergent validity with extroversion, the EORTC-CF was significantly correlated with extroversion. Therefore the divergent validity of the EORTC-CF was not supported. An additional analysis to examine the relationship between the EORTC-CF and neuroticism did not find a significant relationship as would be expected, and as found with the FACT-Cog total score. There was minimal support for criterion validity for both measures. Neither the FACT-Cog total score nor the EORTC-CF was significantly correlated with total neuropsychological performance or with the neuropsychological domain scores (continuous or impairment classifications). When the relationship to the individual test scores as continuous measures was examined, the EORTC-CF yielded similar results to the FACT-Cog total score, with a significant relationship with one of the CPT-II subscales. Relationship of the EORTC-CF to individual test scores classified as impaired or nonimpaired also produced results similar to the FACT-Cog total score, with significant findings mainly within the attention domain. Similar to the FACT-Cog total score, other correlations of individual tests with the EORTC-CF, although nonsignificant, had small to medium effect sizes. Again, this suggests that power may have been an issue for both measures. When examining the relationship of the cognitive functioning measures to demographic and clinical variable, the FACT-Cog total score was significantly correlated with gender only, while the EORTC-CF was significantly correlated with gender, race, and type of BMT transplant. There is no a priori reason to think that cognitive complaints should be related to race or type of BMT transplant. In the absence of an a

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53 priori reason, the relationship of the EORTC-CF to race and type of transplant is undesirable. Although these measures demonstrated similar psychometric properties, the content of the measures varies greatly. A strength of the EORTC-CF is the brevity of the measure. However, this brevity also means that the content of the EORTC-CF is very narrow assessing only memory and attention. In comparison, a weakness of the FACTCog is the length of the measure, but this allows the FACT-Cog to assess broader aspects of cognitive complaints. Although in this sample the FACT-Cog domain scores had similar results to the FACT-Cog total score showing no clear advantage of domain scores, the utility of the FACT-Cog domain scores may yet be identified. Limitations Several limitations of the current study should be noted. First, the cross-sectional design of the study did not allow test-retest reliability to be assessed to demonstrate the temporal stability of the measure. Second, the cross-sectional design also meant that the neuropsychological measures and FACT-Cog were only administered once. Therefore, how changes in cognitive performance may relate to changes in cognitive complaints could not be assessed. Cognitive complaints may not reflect actual cognitive performance, rather they may reflect a change from previous functioning. Looking at discrete cognitive performance in relationship to cognitive complaints may not be an accurate means of evaluating criterion validity. Third, the sample size may have been too small to detect significant differences for small to medium effect sizes. Fourth, the generalizabilty of these results may be limited to patients receiving a BMT. Fifth, the sample was predominantly Caucasian, married, well-educated, and economically stable

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54 potentially limiting the generalizabilty of the results to a more socioeconomically diverse group. A final limitation is that the individual neuropsychological tasks generally did not require sustained effort. Therefore these tasks may not have been demanding enough to simulate the types of cognitive complaints assessed by the FACT-Cog. Anecdotally, patients reported that the CPT-II, a task lasting much longer than any other task, was demanding and required more sustained effort than the other tasks. The significant relationships between the CPT-II subscales and the measures of cognitive complaints may reflect the need for additional tasks that require sustained effort. Clinical Implications These results suggest, therefore, that caution should be used when interpreting patients’ cognitive complaints. The overlap between cognitive complaints and psychosocial measures raises the possibility that a patient reporting difficulty with cognitive functioning may be experiencing psychological distress rather than impaired cognitive functioning. The limited criterion validity of the FACT-Cog and EORTC-CF also suggest that patients’ cognitive complaints are more likely to be related to deficits in attention, than to deficits in memory, executive functioning, and motor coordination. Future Directions Future research should seek to refine the FACT-Cog through item reduction as well as to factor analyze the FACT-Cog to provide support for the domain scores. In addition, more research looking at the relationship of cognitive complaints to cognitive performance is needed. Research utilizing a longitudinal design is important to determine the temporal stability of cognitive complaints as well as to examine how changes in cognitive performance relate to cognitive complaints. The small effects sizes

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55 found in this study suggest the need for research with larger sample sizes to have the ability to detect significant difference for small effect sizes. Additionally, research should be conducted with other clinical populations with high rates of impairment where detection of relationships between objective and subjective aspects of cognitive functioning may be more likely. Future research should include more demanding neuropsychological tasks such as the CPT-II since evidence suggests a stronger relationship between cognitive complaints and tasks requiring sustained effort. Finally, neuropsychological tasks that have greater ecological validity, such as memory tasks that requires recall over several days, should be used to assess the relationship between cognitive performance and cognitive complaints. In conclusion, the present study provides information about the validity and reliability of a new measure to assess cognitive complaint in cancer patients, the FACTCog. Results demonstrated the internal consistency reliability of the FACT-Cog. The concurrent validity of the FACT-Cog was supported by significant relationship to the EORTC-CF. The convergent validity of the FACT-Cog was supported by the significant relationships to measures of depression, fatigue, anxiety, mental well-being, physical well-being, and neuroticism demonstrating the convergent validity of the measure. The divergent validity of the FACT-Cog was supported by the lack of significant relationship with a measure of extroversion. The criterion validity of the FACT-Cog was generally not supported based on the limited number of significant correlations with neuropsychological test scores. The FACT-cog did not demonstrate superior psychometric properties than the EORTC-CF, a commonly used measure of cognitive complaints. Future research is needed to reduce the number of items in the FACT-Cog

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56 and to factor analyze the FACT-Cog to provide support for the domain scores. Additional research should also utilize a longitudinal design, be conducted with other clinical populations, and include demanding neuropsychological tasks that require sustained effort.

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57 Table 1 Demographic Characteristics of Sample (N = 82) ________________________________________________________________ Variable _____ Mean age (SD) 52.91 (12.03) Mean education (SD) 13.76 (2.30) Estimated IQ (SD) 98.5 (15.30) Gender Male 42 (51.2%) Female 40 (48.8%) Ethnicity White/Caucasian 70 (85.4%) Black/African American 7 (8.5%) Latino/Hispanic 4 (4.9%) Other 1 (1.2%) Marital Status Single, never married 4 (4.9%) Married 65 (79.3%) Divorced 9 (11.0%) Widowed 3 (3.7%) Separated 1 (1.2%) Employment status Paid full-time employment 23 (28.1%) Paid part-time employment 5 (6.1%) On leave with pay 7 (8.5%) On leave without pay 8 (9.8%) Not employed – disabled 17 (20.7%) Not employed – retired 11 (13.4%) Not employed – Seeking work 2 (2.4%) Supported by others 9 (11.0%) Total household income* Less than $ 10,000 4 (5.0%) $10,000 $19,999 7 (8.8%) $20,000 $ 39,999 16 (20.0%) $40,000 $59,999 21 (26.3%) $60,000 $100,000 18 (22.5%) Greater than $100,000 12 (15.0%) Data missing for 4 participants

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58 Table 2 Clinical Characteristics of Sample (N = 82) Variable Evaluation Six month follow-up 56 (68.3%) Twelve month follow-up 26 (31.7%) BMT Type Autologous 70 (85.4%) Allogeneic 12 (14.6%) Diagnosis Multiple Myeloma 59 (72.0%) Non Hodgkins Lymphoma 5 (6.1%) Acute Lymphocytic Leukemia 2 (2.4%) Hodgkins Lymphoma 1 (1.2%) Acute Myelogenous Leukemia 4 (4.9%) Breast Cancer 4 (4.9%) Testicular Cancer 1 (1.2%) Aplastic Anemia 1 (1.2%) Myelodysplasia 1 (1.2%) Chronic Myelogenous Leukemia 3 (3.7%) Amyloidosis 1 (1.2%)

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59 Table 3 Correlational Analyses of FACT-Cog and EORTC-CF with Demographic and Clinical Variables FACT-Cog EORTC-CF Total Cognitive IOF QOL Gender .31** .30** .32** .26* .22* Age .03 .07 .04 -.03 .09 Estimated IQ (NART) .18 .15 .13 .22* .10 Years of Education -.02 -.03 -.03 .01 -.14 Race (White/Caucasian or -.13 -.17 -.12 -.09 -.22* All Others) Marital Status .15 .17 .15 .11 .08 Time Since Transplant .03 .01 .06 .02 .08 (6month or 12 month) Type of Transplant -.07 -.08 -.07 -.05 -.27** p < .05 **p < .01 IOF = Interference of Functioning QOL = Quality of Life

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60 Table 4 Correlational Analyses of FACT-Cog and EORTC-CF with Psychosocial Variables FACT-Cog EORTC-CF Total Cognitive IOF QOL Depression (CES-D) .50**** .45**** .44**** .52**** .44**** Fatigue (FSI) .53**** .45**** .49**** .58**** .44**** Anxiety (STAI) .36*** .33** .31** .39*** .35*** Mental Wellbeing (SF-36) -.51**** -.46**** -.50**** -.50**** -.48**** Physical Wellbeing (SF-36) -.29** -.27* -.25* -.32** -.31*** Extroversion (NEO) -.20 -.18 -.25* -.14 -.30** Neuroticism (NEO) .23* .29** .21* .13 .14 p < .05 **p < .01 ***p < .001 **** p < .0001 IOF = Interference of Functioning QOL = Quality of Life

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61 Table 5 Regression Analysis of the FACT-Cog Total Score R2 change Cumulative R2 p value Uniqueness Index Demographic variables Gender .201 .094 .094 .005 .037 Psychosocial variables Fatigue (FSI) .265 .257 .357 .0001 .025 Mental Well-being -.254 .046 .373 .020 .018 (SF-36) Neuroticism (NEO) .118 .007 .380 .362 .011 Anxiety (STAI) -.163 .003 .383 .557 .008 Depression (CES-D) .150 .005 .389 .432 .005 Physical Well-being -.050 .002 .389 .667 .002 (SF-36)

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62 Table 6 Regression Analysis of the FACT-Cog Cognitive Domain R2 change Cumulative R2 p value Uniqueness Index Demographic variables Gender .205 .091 .094 .006 .039 Psychosocial variables Mental Well-being -.225 .183 .274 .0001 .014 (SF-36) Fatigue (FSI) .169 .023 .298 .111 .010 Neuroticism (NEO) .219 .027 .325 .082 .036 Anxiety (STAI) -.229 .006 .331 .425 .016 Depression (CES-D) .208 .010 .340 .295 .009 Physical Well-being -.068 .003 .343 .575 .003 (SF-36)

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63 Table 7 Regression Analysis of the FACT-Cog Interference of Functioning R2 change Cumulative R2 p value Uniqueness Index Demographic variables Gender .226 .100 .100 .004 .047 Psychosocial variables Mental Well-being -.357 .222 .322 .0001 .037 (SF-36) Fatigue (FSI) .239 .029 .351 .065 .021 Extroversion (NEO) -.158 .016 .367 .166 .021 Anxiety (STAI) -.181 .012 .379 .232 .011 Physical Well-being -.029 .001 .379 .786 .001 (SF-36) Depression (CES-D) .047 .000 .380 .819 .001

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64 Table 8 Regression Analysis of the FACT-Cog Quality of Life Domain R2 change Cumulative R2 p value Uniqueness Index Demographic variables Gender .127 .042 .015 IQ (NART) .072 .099 .099 .087 .004 Psychosocial variables Fatigue (FSI) .317 .257 .356 .0001 .033 Mental Well-being -.173 .027 .383 .07 .008 (SF-36) Depression (CES-D) .138 .005 .389 .43 .004 Physical Well-being -.042 .001 .389 .73 .001 (SF-36) Anxiety (STAI) -.033 .000 .390 .83 .000

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65 Table 9 Correlational Analyses of FACT-Cog and EORTC-CF with Neuropsychological Test Performance (Continuous Measures) FACT-Cog EORTC-CF Total Cognitive IOF QOL Total Neuropsychological .06 .07 .07 .05 .11 Performance Memory Domain .11 .11 .10 .08 .05 Executive Functioning -.05 -.12 -.02 .00 -.03 Domain Motor Domain -.18 -.16 -.17 -.17 -.11 Attention Domain .08 .11 .07 .04 .18 IOF = Interference of Functioning QOL = Quality of Life

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66 Table 10 Correlation of FACT-Cog and EORTC-CF with Neuropsychological Test Scores (Continuous Measures) FACT-Cog EORTC-CF Total Cognitive IOF QOL Memory Domain Logical Memory Immediate .07 .08 .08 .05 -.03 Delayed .09 .10 .09 .06 .04 Visual Reproduction Immediate -.19 -.20 -.18 -.16 -.09 Delayed -.11 -.12 -.09 -.10 -.08 Recall .08 .04 .05 .13 -.03 CVLT Total .15 .12 .15 .17 .10 Short Delay Free .14 .16 .14 .10 .15 Short Delay Cued .13 .16 .12 .10 .13 Long Delay Free .15 .16 .14 .11 .13 Long Delay Cued .15 .18 .16 .10 .09 Recognition .13 .16 .12 .09 .01 Discrimination .13 .18 .11 .08 .00 Executive Functioning Domain Digit Symbol -.10 -.06 -.09 -.12 -.06 Trails A .03 -.01 .06 .05 .02 Trails B -.01 -.09 .00 .07 .08 COWA .03 -.05 .05 .10 -.10 Stroop -.11 -.16 -.06 -.09 -.02 Motor Domain Grooved Pegs Dominant -.17 -.16 -.17 -.16 -.16 Non-dominant -.15 -.13 -.15 -.15 -.04 Attention Domain CPT-II Subscales Inattention .01 .04 .02 -.03 .17 Impulsivity .12 .15 .12 .07 .23* Vigilance .18 .17 .14 .21* .02 *p<.05 IOF = Interference of Functioning; QOL = Quality of Life

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67 Table 11 Correlational Analyses of FACT-Cog and EORTC-CF with Neuropsychological Test Performance (Impairment Classification) FACT-Cog EORTC-CF Total Cognitive IOF QOL Total Neuropsychological .01 .04 .03 -.05 .06 Performance Memory Domain -.15 -.18 -.16 -.08 -.16 Executive Functioning .03 .06 .00 .02 .12 Domain Motor Domain .11 .06 .13 .12 .03 Attention Domain .08 .02 .04 .16 .10 IOF = Interference of Functioning QOL = Quality of Life

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68 Table 12 Correlation of FACT-Cog and EORTC-CF with Neuropsychological Test Scores (Impairment Classification) FACT-Cog EORTC-CF Total Cognitive IOF QOL Memory Domain Logical Memory Immediate -.10 -.09 -.11 -.10 -.12 Delayed -.05 -.11 -.07 .03 -.12 Visual Reproduction Immediate .15 .15 .14 .12 .13 Delayed .16 .14 .13 .19 .26* Recall -.10 -.09 -.11 -.10 -.12 CVLT Total -.14 -.18 -.12 -.10 -.15 Short Delay Free -.14 -.18 -.12 -.10 -.15 Short Delay Cued -.18 -.22* -.18 -.12 -.15 Long Delay Free -.19 -.22* -.16 -.18 -.15 Long Delay Cued -.19 -.21 -.16 -.17 -.15 Recognition -.16 -.16 -.14 -.15 .04 Discrimination -.14 -.15 -.13 -.11 -.06 Executive Functioning Domain Digit Symbol .07 .07 .03 .09 .07 Trails A .08 .08 .02 .13 .18 Trails B -.04 -.04 -.05 -.01 -.10 COWA -.01 .04 -.01 -.06 .18 Stroop .01 .03 -.03 .02 -.10 Motor Domain Grooved Pegs Dominant .12 .09 .14 .11 .14 Non-dominant .14 .07 .17 .15 .08 Attention Domain CPT-II Subscales Inattention .16 .14 .13 .19 .26* Impulsivity .28** .23* .24* .33** .30** Vigilance .22* .18 .16 .29** .20 *p<.05, **p<.01 IOF = Interference of Functioning; QOL = Quality of Life

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69 Table 13 Regression Analysis of the EORTC-CF Score R2 change Cumulative R2 p value Uniqueness Index Demographic variables Gender .152 .016 .021 Race (White or other) -.137 .150 .016 Transplant (auto/allo) -.260 .160 .160 .028 .057 Psychosocial variables Mental Well-being -.284 .207 .367 .0001 .023 (SF-36) Fatigue (FSI) .198 .029 .396 .060 .014 Extroversion (NEO) -.193 .034 .430 .039 .031 Physical Well-being -.078 .003 .433 .528 .004 (SF-36) Anxiety (STAI) -.059 .001 .434 .728 .001 Depression (CES-D) .032 .000 .434 .823 .000

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73 Harder, H., Cornelissen, J.J., Van Gool, A.R., Duivenvoorden, H.J., Eijkenboom, W.M.H., & van den Bent, M.J. (2002). Cognitive functioning and quality of life in long-term adult survivors of bone marrow transplantation. Cancer, 95(1) 183192. Heaton, R.K. (1992). Comprehensive Norms for an Expanded Halstead-Reitan Battery: A Supplement for the Wechsler Adult Intelligence Scales – Revised (WAIS-R) Odessa, FL: Psychological Assessments Resources. Heaton, R.K., Grant, I., & Matthews, C.G. (1991). Comprehensive Norms for an Expanded Halstead-Reitan Battery: Demographic Correction, Research Findings, and Clinical Applications. Odessa, FL: Psychological Assessment Resources. Hjermstad, M.J., Holte, H., Evensen, S.A., Fayers, P.M., & Kaasa, S. (1999). Do patients who are treated with stem cell transplantation have a health-related quality of life comparable to the general population after 1 year? Bone Marrow Transplant, 24(8) 911-918. Joly, F., Brune, D., Couette, D.B., Lesaunier, F., Heron, J.F., Peny, J., & Henry-Amar, M. (1998). Health-related quality of life and sequelae in patients treated with brachytherapy and external beam irradiation for localized prostate cancer. Annals of Oncology, 9 751-757.

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74 Klein, M., Heimans, J.J., Aaronson, N.K., van der Ploeg, H.M., Grit, J., Muller, M., Postma, T.J., Mooij, J.J., Boerman, R.H., Beute, G.N., Ossenkoppele, G.J., van Imhoff, G.W., Dekker, A.W., Jolles, J., Slotman, B.J., Struikmans, H., & Taphoorn, M.J.B. (2002). Effect of radiotherapy and other treatment-related factors on mid-term to long-term cognitive sequelae in low-grade gliomas: a comparative study. Lancet, 360(9343) 1361-1368. Lezak, MD. (1995). Neuropsychological assessment, 3rd ed. New York, NY: Oxford University Press. Matthews, C.G. & Klove, H. (1964). Instruction Manual for the Adult Neuropsychology Test Battery Madison, WI: University of Wisconsin Medical School. McHorney, C.A., Ware, J.E., & Raczek, A.E. (1993). The MOS Short-Form Health Survey (SF-36): II. Psychometric and clinical tests of validity in measuring the physical and mental health constructs. Medical Care, 31 247-263. McNair, D.M., Lorr, M., & Droppleman, L. (1971). POMS Manual. San Diego, CA: Educational and Testing Services. Nelson, H.E. (1982). The National Adult Reading Test (NART): Test Manual. Windsoe, Berks, U.K.: NFER-Nelson. Olin, J.J. (2001). Cognitive function after systemic therapy for breast cancer. Oncology, 15, 613-624. Radloff, L.S. (1977). The CES-D scale: a self-report depression scale for research in the general population. Applied Psychological Measurement, 1, 385-401. Reitan, R.M. (1958). The validity of the Trail Making Test as an indicator of organic brain damage. Perceptual and Motor Skills, 8 271-276.

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75 Reitan, R.M. & Wolfson, D. (1993). The Halstead-Reitan Neuropsychological Test Battery: Theory and Clinical Interpretation Tuscan, AZ: Neuropsychology Press. Schagen, S.B., Muller, M.J., Boogerd, W., Rosenbrand, R.M., van Rhijn, D., Rodenhuis, S., & van Dam, F.S. (2002). Late effects of adjuvant chemotherapy on cognitive function: a follow-up study in breast cancer patients. Annals of Oncology, 13(9) 1387-1397. Schagen, S.B., van Dam, F.S., Muller, M.J., Boogerd, W., Lindeboom, J., & Bruning, P.F. (1999). Cognitive deficits after postoperative adjuvant chemotherapy for breast carcinoma. Cancer, 85(3) 640-650. Servaes, P., Verhagen, C.A., & Bleijenberg, G. (2002). Relations between fatigue, neuropsychological functioning, and physical activity after treatment for breast carcinoma Daily self-report and objective behavior. Cancer, 95(9) 2017-2026. Spielberger, C. D., Gorsuch, R. L., Lushene, R., Vagg, P. R., & Jacobs, G. A. (1983). Manual for the State–Trait Anxiety Inventory ( Form Y ). Palo Alto, CA: Consulting Psychologists Press. Spreen, O. & Strauss, E. (1998). A Compendium of Neuropsychological Tests – Second Edition. New York, NY: The Oxford University Press. Squire, L.R., Wetzel, C.D., & Slater, P.C. (1979). Memory complaint after electroconvulsive therapy: Assessment with a new self-rating instrument. Biological Psychiatry, 14(5) 791-801. Stewart, A.L. & Ware, J.E. (1992). Measuring Functioning and Well-Being: The Medical Outcomes Study Approach Durham, NC: Duke University Press.

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76 Trenarry, M.R., Crosson, B., DeBoe, J., & Leber, W.R. (1989). The Stroop Neuropsychological Screening Test. Lutz, FL: Psychological Assessment Resources. Van Dam, F., Schagen, S., Muller, M., Boogerd, W., van dam Wall, E., Droogleever Forttuyn, M., & Rodenhuis, S. (1998). Impairment of cognitive function in women receiving adjuvant treatment for high-risk breast cancer: High dose versus standard-dose chemotherapy. Journal of the National Cancer Institute, 90(3) 210-218. Van der Zee, K., Buunk, B., Sanderman, R., Botke, G., & Van der Bergh, F. (1999). The Big Five and identification-contrast processes in social comparison in adjustment to cancer treatment. European Journal of Personality, 13, 307-326. Vercoulen, J.H., Swanink, C.M., Fennis, J.F., Galama, J.M., Van-der-Meer, J.W., & Bleijenberg, G. (1994). Dimensional assessment of chronic fatigue syndrome. Journal of Psychosomatic Research, 38 383-392. Ware, J.E., Snow, K.K., Kosinski, M., & Gandek, B. (1993). SF-36 Health Survey Manual and Interpretation Guide. Boston, MA: The Health Institute, The New England Medical Center. Ware, J.E. & Sherbourne, C.D. (1992). The MOS Short-Form Health Survey (SF-36): I. Conceptual framework and item selection. Medical Care, 30(6) 473-483. Wagner, L.I., Sweet, J., Cella, D., & Doninger, N. (2003, March). Chemotherapyrelated cognitive deficits: A qualitative examination of patients and providers. Presented at the 24th Annual Meeting and Scientific Session of the Society of Behavioral Medicine, Salt Lake City, UT.

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77 Wechsler, D. (1981). Wechsler Adult Intelligence Scale – Revised Administration and Scoring Manual. San Antonio, TX: The Psychological Corporation. Wechsler, D. (1997). Wechsler Memory Scale-III Manual San Antonio, TX: The Psychological Corporation.

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78 Appendices

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79 Appendix A: Functional Assessment of Cancer Therapy Cognitive Scale Below is a list of statements that other people with your condition have said are important. By circling one (1) number per line, please indicate how often each of the following has occurred during the past 7 days. Never About once a week Two to three times a week Nearly every day Several times a day I have had trouble forming thoughts....0 1 2 3 4 My thinking has been unclear..............0 1 2 3 4 My thinking has been slow..................0 1 2 3 4 My thinking has been foggy.................0 1 2 3 4 I have had trouble adding or subtractin g numbers in m y head........... 0 1 2 3 4 I have made mistakes when writing down phone numbers........................... 0 1 2 3 4 I have had trouble concentrating..........0 1 2 3 4 I have had trouble remembering the name of a fa miliar pe rson.................... 0 1 2 3 4 I have had trouble finding my way to a familiar place.................................... 0 1 2 3 4 I have had trouble remembering where I put things, like my keys or my wallet............................................. 0 1 2 3 4 I have had trouble remembering whether I did things I was supposed to do, like taking a medicine or buying something I needed.................. 0 1 2 3 4 I have had trouble remembering new information, like phone numbers or sim p le instructions .............................. 0 1 2 3 4 I have had trouble recalling the name of an object while talking to someone 0 1 2 3 4 Words I wanted to use have seemed to be on the “tip of my tongue”............ 0 1 2 3 4 I have had trouble finding the right word(s) to express mysel f .................... 0 1 2 3 4

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80 Appendix A: Functional Assessment of Cancer Therapy Cognitive Scale (Continued) By circling one (1) number per line, please indicate how often each statement has occurred during the past 7 days. Never About once a week Two to three times a week Nearly every day Several times a day I have used the wrong word when I referred to an object................................. 0 1 2 3 4 I have had trouble speaking fluently.........0 1 2 3 4 I have had trouble saying what I mean in conversations with others......................... 0 1 2 3 4 I have needed to keep a written list so I would not forget things............................ 0 1 2 3 4 I have walked into a room and forgotten what I meant to get or do there................. 0 1 2 3 4 I have needed medical instructions repeated because I could not keep them straight.................................................... 0 1 2 3 4 I have forgotten or accidentally missed medical appointments.............................. 0 1 2 3 4 I have had to work really hard to pay attention or else I would forget what I was doing................................................ 0 1 2 3 4 I have had to work really hard to pay attention or I would make a mistake......... 0 1 2 3 4 I have forgotten names of people soon after being introduced.............................. 0 1 2 3 4 My reactions in everyday situations have been slow........................................ 0 1 2 3 4 Other people have noticed that I had problems remembering information ......... 0 1 2 3 4 Other people have noticed that I had problems speaking clearly ........................ 0 1 2 3 4 Other people have noticed that I had problems thinking clearly ........................ 0 1 2 3 4

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81 Appendix A: Functional Assessment of Cancer Therapy Cognitive Scale (Continued) By circling one (1) number per line, please indicate how often each statement has occurred during the past 7 days. Never About once a week Two to three times a week Nearly every day Several times a day It has seemed like my brain was not working as well as usual .................... 0 1 2 3 4 I have had to work harder than usual to remember things............................. 0 1 2 3 4 I have had to work harder than usual to keep track of what I was doing........ 0 1 2 3 4 My thinking has been slower than usual................................................... 0 1 2 3 4 I have had to work harder than usual to express myself clearly..................... 0 1 2 3 4 I have had more problems conversing with others.......................................... 0 1 2 3 4

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82 Appendix A: Functional Assessment of Cancer Therapy Cognitive Scale (Continued) Please answer the remaining questions with regard to all the above concerns that you have identified. Never About once a week Two to three times a week Nearly every day Several times a day I have hidden these problems so others would not notice....................... 0 1 2 3 4 I have been upset about these problems............................................. 0 1 2 3 4 I have told others about these problems............................................. 0 1 2 3 4 These problems have interfered with my ability to work............................... 0 1 2 3 4 These problems have interfered with my ability to do things I enjoy............. 0 1 2 3 4 I have tried to do things (like writing lists or keeping a calendar) so these problems would not interfere.............. 0 1 2 3 4 These problems have been frustrating for me................................................. 0 1 2 3 4 These problems have interfered with the quality of my life........................... 0 1 2 3 4

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83 Appendix A: Functional Assessment of Cancer Therapy Cognitive Scale (Continued) Please answer the remaining questions with regard to all the above concerns that you have identified. Not at all A little bit Somewhat Quite a bit Very much I have hidden these problems so others would not notice.................... 0 1 2 3 4 I have been upset about these problems.......................................... 0 1 2 3 4 I have told others about these problems.......................................... 0 1 2 3 4 These problems have interfered with my ability to work.................... 0 1 2 3 4 These problems have interfered with my ability to do things I enjoy.. 0 1 2 3 4 I have tried to do things (like writing lists or keeping a calendar) so these problems would not interfere........................................... 0 1 2 3 4 These problems have been frustrating for me............................. 0 1 2 3 4 These problems have interfered with the quality of my life................ 0 1 2 3 4

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84 Appendix B: EORTC QLQ-C30 Cognitive Functioning Scale Directions: For each item below, please check the ONE box. During the past week: Not at A Quite Very all little a bit much 1. Have you had difficulty in concentrating on things, like reading a newspaper or watching television? 2. Have you had difficulty remembering things?

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85 Appendix C: Center for Epidemiological Studies – Depression For each statement below, make an “X” in the box which best describes how often you felt or behaved this way-DURING THE PAST WEEK, INCLUDING TODAY. Rarely or Some or Occasionally Most or None of a little or a moderate all of of the time of the time amount of the the time (< 1 day) (1-2 days) (3-4 days) (5-7 days) DURING THE PAST WEEK: 1. I was bothered by things that usually don't bother me............................ 2. I did not feel like eating; my appetite was poor.................................... 3. I felt that I could not shake off the blues even with help from my family or friends....................................... 4. I felt that I was just as good as other people............................................. 5. I had trouble keeping my mind on what I was doing...................................... 6. I felt depressed........................................ 7. I felt that everything I did was an effort................................................... 8. I felt hopeful about the future................... 9. I thought my life had been a failure.......... 10. I felt fearful............................................... 11. My sleep wa s restless.............................. 12. I wa s happy............................................. 13. I talked less than usual............................ 14. I felt lonely............................................... 15. People were unfriendly............................ 16. I enjoy ed life............................................ 17. I had cryi ng spells.................................... 18. I felt sad................................................... 19. I felt that people disliked me..................... 20. I could not “get going”..............................

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86 Appendix D: State-Trait Anxiety Inventory DIRECTIONS: A number of statements which people have used to describe themselves are given below. Read each statement and then check the appropriate box to the right of the statement to indicate how you feel right now that is, at this moment There are no right or wrong answers. Do not spend too much time on any one statement but give the answer which seems to describe your present feelings best. NOT SOMEWHAT MODERATELY VERY AT ALL SO MUCH SO 1. I feel calm.. ............................ 2. I feel secure............................ 3. I am tense.............................. 4. I feel strained.......................... 5. I feel at ease........................... 6. I feel upset.............................. 7. I am presently worrying over possible misfortunes....... 8. I feel satisfied......................... 9. I feel frightened.. ................... 10. I feel comfortable.................... 11. I feel self-confident................. 12. I feel nervous.......................... 13. I am jittery............................... 14. I feel indecisive.......................

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87 Appendix D: State-Trait Anxiety Inventory (Continued) NOT SOMEWHAT MODERATELY VERY AT ALL SO MUCH SO 15. I am relaxed........................... 16. I feel content........................... 17. I am worried........................... 18. I feel confused........................ 19. I feel steady............................ 20. I feel pleasant.........................

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88 Appendix E: Fatigue Symptom Inventory PART I For each of the following, circle the one number that best indicates how that item applies to you. 1. Rate your level of fatigue on the day you felt most fatigued during the past week. 0 1 2 3 4 5 6 7 8 9 10 Not at all As fatigued fatigued as I could be 2. Rate your level of fatigue on the day you felt least fatigued during the past week. 0 1 2 3 4 5 6 7 8 9 10 Not at all As fatigued fatigued as I could be 3. Rate your level of fatigue on the average in the last week. 0 1 2 3 4 5 6 7 8 9 10 Not at all As fatigued fatigued as I could be 4. Rate your level of fatigue right now 0 1 2 3 4 5 6 7 8 9 10 Not at all As fatigued fatigued as I could be 5. Rate how much, in the past week, fatigue interfered with your general level of activity : 0 1 2 3 4 5 6 7 8 9 10 No Extreme interference interference 6. Rate how much, in the past week, fatigue interfered with your ability to bathe and dress yourself : 0 1 2 3 4 5 6 7 8 9 10 No Extreme interference interference 7. Rate how much, in the past week, fatigue interfered with your normal work activity (includes both work outside the home and housework) : 0 1 2 3 4 5 6 7 8 9 10 No Extreme interference interference

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89 Appendix E: Fatigue Symptom Inventory (Continued) 8. Rate how much, in the past week, fatigue interfered with your ability to concentrate : 0 1 2 3 4 5 6 7 8 9 10 No Extreme interference interference 9. Rate how much, in the past week, fatigue interfered with your relations with other people : 0 1 2 3 4 5 6 7 8 9 10 No Extreme interference interference 10. Rate how much, in the past week, fatigue interfered with your enjoyment of life : 0 1 2 3 4 5 6 7 8 9 10 No Extreme interference interference 11. Rate how much, in the past week, fatigue interfered with your mood : 0 1 2 3 4 5 6 7 8 9 10 No Extreme interference interference 12. Indicate how many days in the past week, you felt fatigued for any part of the day: 0 1 2 3 4 5 6 7 Days Days 13. Rate how much of the day on average, you felt fatigued in the past week: 0 1 2 3 4 5 6 7 8 9 10 None of The entire the day day 14. Indicate which of the following best describes the daily pattern of your fatigue in the past week: 0 1 2 3 4 Not at all Worse in Worse in the Worse in No consistent daily fatigued the morning afternoon the evening pattern of fatigue

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90 Appendix F: Medical Outcome SF-36 Health Survey INSTRUCTIONS: This survey asks for your views about your health. This information will help keep track of how you feel and how well you are able to do your usual activities. Answer every question by marking the answer as indicated. If you are unsure about how to answer a question, please give the best answer you can. 1. In general, would you say your health is (check one): Excellent Very good Good Fair Poor 2. Compared to one year ago how would you rate your health in general now ? (check one) Much better now than one year ago Somewhat better now than one year ago About the same as one year ago Somewhat worse now than one year ago Much worse than one year ago 3. The following items are about activities you might do during a typical day. Does your health now limit you in these activities? If so, how much? (check appropriate answer) Yes, Limited a lot Yes, Limited a little No, Not limited at all a. Vigorous activities such as running, lifting heavy objects, participating in strenuous sports b. Moderate activities such as moving a table, pushing a vacuum cleaner, bowling, or playing golf c. Lifting or carrying groceries d. Climbing several flights of stairs e. Climbing one flight of stairs f. Bending, kneeling or stooping g. Walking more than a mile h. Walking several blocks i. Walking one block

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91 Appendix F: Medical Outcome SF-36 Health Survey (Continued) 4. During the past 4 weeks have you had any of the following problems with your work or other regular daily activities as a result of your physical health ? (check yes or no for each) Yes No a. Cut down the amount of time you spent on work or other activities b Accomplished less than you would like c. Were limited in the kind of work or other activities d. Had difficulty performing the work or other activities (for example, it took extra effort) 5. During the past 4 weeks have you had any of the following problems with your work or other regular daily activities as a result any emotional problems (such as feeling depressed or anxious)? (check yes or no for each) Yes No a. Cut down the amount of time you spent on work or other activities b Accomplished less than you would like c. Didn't do work or other activities as carefully as usual 6. During the past 4 weeks to what extent has your physical health or emotional problems interfered with your normal social activities with family, friends, neighbors, or groups? (check one) Not at all Slightly Moderately Quite a bit Extremely 7. How much bodily pain have you had during the past 4 weeks ? (check one) None Very mild Mild Moderate Severe Very severe

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92 Appendix F: Medical Outcome SF-36 Health Survey (Continued) 8. During the past 4 weeks how much did pain interfere with your normal work (including both work outside the home and housework)? (check one) Not at all A little bit Moderately Quite a bit Extremely 9. These questions are about how you feel and how things have been with you during the past 4 weeks For each question, please give the one answer that comes closest to the way you have been feeling. (check appropriate answer). How much of the time during the past 4 weeks : All of the time Most of the time A good bit of the time Some of the time A little of the time None of the time a. Did you feel full of pep? b. Have you been a very nervous person? c. Have you felt so down in the dumps that nothing could cheer you up? d. Have you felt calm and peaceful? e. Did you have a lot of energy? f. Have you felt downhearted and blue? g. Did you feel worn out? h. Have you been a happy person? i. Did you feel tired?

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93 Appendix F: Medical Outcome SF-36 Health Survey (Continued) 10. During the past 4 weeks how much of the time has your physical health or emotional problems interfered with your social activities (like visiting with friends, relatives, etc.)? (check one) All of the time Most of the time Some of the time A little of the time None of the time 11. How TRUE or FALSE is each of the following statements for you? (check appropriate answer) Definitely true Mostly true Don't know Mostly false Definitely false a. I seem to get sick a little easier than other people b. I am as healthy as anybody I know c. I expect my health to get worse d. My health is excellent

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94 Appendix G: NEO – Five-Factor Inventory Instructions: This questionnaire contains 60 statements. Read each statement carefully. For each statement, check the box that goes with the response that best represents your opinion. Check only one box for each statement. Strongly Strongly Disagree Disagree Neutral Agree Agree 1. I am not a worrier................................................. .... 2. I like to have a lot of people around me .............. 3. I don’t like to waste my time daydreaming........... 4. I try to be courteous to everyone I meet ................ 5. I keep my belongings clean and neat.................... 6. I often feel inferior to others................................. 7. I laugh easily ................................................... 8. Once I find the right way to do something, I stick to it ................................................... 9. I often get into arguments with my family and co-workers ................................................... 10. I’m pretty good about pacing myself so as to get things done on time ............................. 11. When I am under a great deal of stress, sometimes I feel like I’m going to pieces.............. 12. I don’t consider myself especially “light-hearted.” ................................................... 13. I am intrigued by the patterns I find in art and nature ................................................... 14. Some people think I’m selfish and egotistical........ 15. I am not a very methodical person......................... 16. I rarely feel lonely or blue.....................................

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95 Appendix G: NEO – Five-Factor Inventory (Continued) Strongly Strongly Disagree Disagree Neutral Agree Agree 17. I really enjoy talking to people.............................. 18. I believe letting students hear controversial speakers can only confuse and mislead them......... 19. I would rather cooperate with others than................. compete with them................................................ 20. I try to perform all the tasks assigned to me conscientiously................................................ 21. I often feel tense and jittery................................... 22. I like to be where the action is............................... 23. Poetry has little or no effect on me........................ 24. I tend to be cynical and skeptical of others’ intentions ................................................... 25. I have a clear set of goals and work toward them in an orderly fashion..................................... 26. Sometimes I feel completely worthless.................. 27. I usually prefer to do things alone.......................... 28. I often try new and foreign foods........................... 29. I believe that most people will take advantage of you if you let them............................. 30. I waste a lot of time before settling down to work ................................................... 31. I rarely feel fearful or anxious................................ 32. I often feel as if I’m bursting with energy............... 33. I seldom notice the moods or feelings that different environments produce.......................

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96 Appendix G: NEO – Five-Factor Inventory (Continued) Strongly Strongly Disagree Disagree Neutral Agree Agree 34. Most people I know like me .................................. 35. I work hard to accomplish my goals...................... 36. I often get angry at the way people treat me........... 37. I am a cheerful, high-spirited person...................... 38. I believe we should look to our religious................... authorities for decisions on moral issues................ 39. Some people think of me as cold and calculating ................................................... 40. When I make a commitment, I can always be counted on to follow through............................ 41. Too often, when things go wrong, I get .................... discouraged and feel like giving up........................ 42. I am not a cheerful optimist................................... 43. Sometimes when I am reading poetry.... or looking at a work of art, I feel a chill or wave of excitement........................................... 44. I’m hard-headed and tough-minded in my attitudes ................................................... 45. Sometimes I’m not as dependable or reliable as I should be............................................ 46. I am seldom sad or depressed................................ 47. My life is fast-paced.............................................. 48. I have little interest in speculating on the nature of the universe or the human condition ................................................... 49. I generally try to be thoughtful and considerate......

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97 Appendix G: NEO – Five-Factor Inventory (Continued) Strongly Strongly Disagree Disagree Neutral Agree Agree 50. I am a productive person who always get the job done ................................................... 51. I often feel helpless and want someone else to solve my problems..................................... 52. I am a very active person....................................... 53. I have a lot of intellectual curiosity........................ 54. If I don’t like people, I let them know it ................. 55. I never seem to be able to get organized................ 56. At times I have been so ashamed I just want to hide ................................................... 57. I would rather go my own way then be a leader of others ................................................... 58. I often enjoy playing with theories or abstract ideas ................................................... 59. If necessary, I am willing to manipulate people to get what I want....................................... 60. I strive for excellence in everything I do................

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98 Appendix H: Background Interview BACKGROUND INTERVIEW Name: MR#: Age/DOB: Handedness: Race: Marital Status: Referring M.D.: Date of Assessment: ECOG (neuro only): Karnofsky (neuro only): History of Present Illness: Diagnosis: Diagnosis date: BMT type: Treatment so far? Psychiatric History: Have you ever seen a psychiatrist or other mental health professional? YES NO Were you ever hospitalized for mental problems? YES NO Do you see a psychiatrist or other mental health professional now? YES NO Current Medications: Family Medical and Psychiatric History: Is there a family history of cancer? Are there family members with mental problems? Alcohol? Drugs? YES NO

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99 Appendix H: Background Interview (Continued) Social History: Who do you live with? Where do you live? Do you have any children? How far did you go in school? Any learning or attention problems as you were going through school? Are you currently working? If not, when did you stop? Do you receive SSI or disability? How have you been sleeping? How is your appetite? Do you have a history of smoking? Alcohol consumption? Illicit drug use? How much caffeine do you typically drink? Do you have any other medical history of which we should be aware? Do you have any history of head injury of loss of consciousness? Did this leave any lasting effects? Mental Status (any comments):

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100 Appendix H: Background Interview (Continued) MENTAL STATUS EXAM Appearance: (hygiene, dress, eye contact, posture, gait, level of consciousness, attentiveness) Does he/she appear his/her chronological age? Attitude: __ Cooperative __ Uncooperative Activity: __ Normal __ Psychomotor Retardation (or) __ Agitation __ Tremor Mood: __ Euthymic __ Dysphoric __ Angry __ Anxious __ Apathetic Affect: (parameters: appropriateness, intensity, mobility, range reactivity) __ Incongruent __ Flat __ Tearful __ Labile __ Appropriate __ Normal __ Full Range Speech: (rate, flow, volume, clarity, spontaneity, word finding difficulties) Thought Process: __ Organized __ Disorganized __ Tangential __ Loose Association Level of Consciousness: __ Alert __ Drowsy __ Delirium __ Stupor Depression: (2 week period) __ Depressed Mood __ Diminished interest/pleasure __ Weight Loss __ Insomnia/hyper __ Psychomotor changes __ Fatigue/Loss of energy __ Worthlessness/guilt __ Poor concentration/decision making __ Thoughts of death/suicidal ideation Adjustment: (3 months) __ Marked Distress __ Impairment (social/occupational) __Depressed __ Anxiety __ Mixed

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101 Appendix I: National Adult Reading Test

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102 Appendix J: Conners’ Continuous Performance Task-II

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103 Appendix J: Conners’ Continuous Performance Task-II (Continued)

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104 Appendix K: California Verbal Learning Test

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105 Appendix K: California Verbal Learning Test (Continued)

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106 Appendix K: California Verbal Learning Test (Continued)

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107 Appendix L: Logical Memory

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108 Appendix L: Logical Memory (Continued)

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109 Appendix L: Logical Memory (Continued)

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110 Appendix M: Visual Reproduction

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111 Appendix M: Visual Reproduction (Continued)

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112 Appendix N: Digit Symbol

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113 Appendix O: Trail Making Test A

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114 Appendix P: Trail Making Test B

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115 Appendix Q: Controlled Oral Word Association

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116 Appendix R: Stroop

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117 Appendix S: Grooved Pegboard


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Validation of the functional assessment of cancer therapy cognitive scale with bone marrow transplant patients
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by Sheri R. Jacobs.
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[Tampa, Fla.] :
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2004.
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Thesis (M.A.)--University of South Florida, 2004.
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ABSTRACT: Research has demonstrated that cancer patients report problems with cognitive functioning related to their cancer and their cancer treatments. Cognitive complaints refer to subjective reports of problems such as decreased memory, attention, concentration, and language skills. These problems with cognitive functioning can interfere with a persons quality of life. The current measures of cognitive complaints have poor or unknown psychometric properties. Therefore, the present study sought to examine the psychometric properties of a newly developed measure of cognitive complaints for cancer patients, the Functional Assessment of Cancer Therapy Cognitive Scale (FACT-Cog). Eighty-two patients were administered a comprehensive battery of neuropsychological tests assessing memory, executive functioning, motor, and attention, as well as a battery of psychosocial measures six months or twelve months after receiving a bone marrow transplant.Results indicated that the internal consistency reliability of the FACT-Cog was high. Concurrent validity was evidenced by the significant relationship of the FACT-Cog to another measure of cognitive complaints. Convergent validity is evidenced by the significant relationship of the FACT-Cog to measures of depression, fatigue, anxiety, mental well-being, and physical well-being. Divergent validity was evidenced by the lack of significant relationship of the FACT-Cog to a measure of extroversion. In contrast, there was limited support for the criterion validity of the FACT-Cog as evidenced by the limited significant relationships with neuropsychological test scores. The FACT-Cog did not demonstrate superior psychometric properties to an existing measure of cognitive complaints (EORTC-CF).
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Adviser: Paul Jacobsen.
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Cognitive complaints.
Quality of life.
Cognitive functioning.
Neoplasms.
Psychometrics.
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