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The experience of fatigue and quality of life in patients with advanced lung cancer
h [electronic resource] /
by Andrea Shaffer.
[Tampa, Fla] :
b University of South Florida,
Title from PDF of title page.
Document formatted into pages; contains 56 pages.
Thesis (M.S.)--University of South Florida, 2009.
Includes bibliographical references.
Text (Electronic thesis) in PDF format.
ABSTRACT: Fatigue is the most prevalent and distressing symptom experienced by patients with advanced lung cancer and especially among those patients undergoing therapy. Advanced lung cancer and its associated symptoms can significantly impact the quality of life (QOL) of those who have the disease. The primary purpose of this study was to measure fatigue levels, characterize the fatigue experience, and assess for gender differences in perceptions of fatigue and QOL in patients with advanced lung cancer receiving chemotherapy. The secondary purpose of the study was to examine practice patterns in the ambulatory setting regarding the routine assessment of fatigue. The study was a secondary analysis of a larger study being conducted in the ambulatory clinics of a large, National Cancer Institute-designated comprehensive cancer center. The study sample consisted of fifty advanced lung cancer patients, 25 men and 25 women.Two self-report questionnaires, the Short-Form 36 (SF-36) Acute Version 1 and Fatigue Symptom Inventory (FSI), were completed by the subjects after receiving a single cycle of chemotherapy. A chart audit of the 50 subjects was performed assessing for provider documentation of fatigue assessment and method(s) utilized. Subjects ranged in age from 40 to 80, with a mean age of 62.4 years. Of the 50, 26 patients had Stage IV non-small cell lung cancer. A majority of the patients were receiving chemotherapy alone and had not received prior chemotherapy. The results of this study revealed no significant gender differences in fatigue severity, frequency, or interference levels. The study results also failed to confirm gender differences in QOL measures. The chart audit did reveal that the providers in this study did not consistently assess and document fatigue levels, with the nurses documenting less frequently than the physicians.The results of this study did suggest that fatigue levels and QOL are problematic for patients treated for lung cancer. In an effort to better assist patients and tailor plans of care, it is vital that practitioners, especially nurses, assess for fatigue in advanced lung cancer patients.
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Advisor: Cindy Tofthagen, Ph.D.
prevention & control.
Quality of Life.
Measures of fatigue
t USF Electronic Theses and Dissertations.
The Experience of Fatigue and Quality of Life in Patients with Advanced Lung Cancer by Andrea Shaffer A thesis submitted in partial fulfillment of the requirements for the degree of Master of Science College of Nursing University of South Florida Major Professor: Cindy Tofthagen, Ph.D., ARNP Susan C. McMillan, Ph.D., ARNP Joan Gregory, Ph.D., ARNP Date of Approval: November 19, 2009 Keywords: Chemotherapy, Malignancy, Gender, Women, Measures of fatigue Copyright 2009, Andrea Shaffer
Dedication I would like to thank Dr. Cindy Tofthagen and Dr. S usan McMillan for their advisement, unyielding encouragement, and countless hours spent assisting me on staying on track. I am grateful to Dr. Joan Gre gory for being ever present and a bright, positive influence during my experience. To my husband, Paul, I thank you for all of your support and love during this fi ve year journey. I must recognize my parents, Ron and Ilse, for their love, patience, and willingness at a momentÂ’s notice to be available to watch my childre n or doing anything else that would allow me to pursue this endeavor. Last, but not least, I need to thank my wonderful colleagues, especially Deborah Boyette an d Dianne Paiva, for always being there, for moral support, and covering my wor k so that I could complete my education. You are the best coworkers and friends one could hope for and I am truly blessed.
i Table of Contents List of Tables iii Abstract iv Chapter One Introduction 1 Statement of Problem 4 Research Questions 5 Definition of Terms 6 Significance to Nursing 6 Chapter Two Review of Literature 7 Quality of Life and Fatigue 7 Gender and Fatigue 13 Fatigue Assessment 20 Summary 22 Chapter Three Methods 23 Setting and Sample 23 Instrumentation 24 Short-Form 36 (SF-36) Acute Version 1 24 Reliability and validity 25 Fatigue Symptom Inventory (FSI) 25 Reliability and validity 25 Demographic Data form 26 Chart Audit Form 26 Institutional Approvals 26 Procedures 27 Data Analysis 27 Chapter Four Results, Discussion and Conclusions 28 Results 28 Fatigue Symptom Inventory (FSI) 30 Short-Form 36 (SF-36) 32 Chart Audit Form 33
ii Discussion 34 Demographic Data 34 Fatigue Symptom Inventory (FSI) 35 SF-36 36 Fatigue Assessment 36 Implications for Nursing 37 Conclusions 37 Recommendations for Future Research 38 References 39 Appendices 42 Appendix A: Chart Audit Form 43 Appendix B: Medical Chart Review Form 44 Appendix C: Demographic Form 47 Appendix D: FSI Questionnaire 50 Appendix E: SF-36 52
iii List of Tables Table 1. Frequency and Percent of Sample Demographi c 28 Characteristics Table 2. Frequency and Percent of Employment Status and 29 Household Income Table 3. Frequency and Percent of Disease and Plann ed 30 Additional Therapy Table 4. Means and Standard Deviations with Indepen dent t-test 31 Comparison of Severity and Frequency Items on t he FSI Questionnaire Table 5. Means and Standard Deviations with Indepen dent t-test 32 Comparison of Interference Items on the FSI Que stionnaire Table 6. Means and Standard Deviations with Indepen dent t-test 33 Comparison of Items on the SF-36 Questionnaire
iv The Experience of Fatigue and Quality of Life in Pa tients with Advanced Lung Cancer Andrea Shaffer ABSTRACT Fatigue is the most prevalent and distressing sympt om experienced by patients with advanced lung cancer and especially a mong those patients undergoing therapy. Advanced lung cancer and its a ssociated symptoms can significantly impact the quality of life (QOL) of t hose who have the disease. The primary purpose of this study was to measure fatigu e levels, characterize the fatigue experience, and assess for gender differenc es in perceptions of fatigue and QOL in patients with advanced lung cancer recei ving chemotherapy. The secondary purpose of the study was to examine pract ice patterns in the ambulatory setting regarding the routine assessment of fatigue. The study was a secondary analysis of a larger stud y being conducted in the ambulatory clinics of a large, National Cancer Institute-designated comprehensive cancer center. The study sample cons isted of fifty advanced lung cancer patients, 25 men and 25 women. Two sel f-report questionnaires, the Short-Form 36 (SF-36) Acute Version 1 and Fatigue Symptom Inventory (FSI), were completed by the subjects after receiving a si ngle cycle of chemotherapy.
v A chart audit of the 50 subjects was performed asse ssing for provider documentation of fatigue assessment and method(s) u tilized. Subjects ranged in age from 40 to 80, with a mean a ge of 62.4 years. Of the 50, 26 patients had Stage IV non-small cell lun g cancer. A majority of the patients were receiving chemotherapy alone and had not received prior chemotherapy. The results of this study revealed no significant g ender differences in fatigue severity, frequency, or interference levels The study results also failed to confirm gender differences in QOL measures. The ch art audit did reveal that the providers in this study did not consistently assess and document fatigue levels, with the nurses documenting less frequently than th e physicians. The results of this study did suggest that fatigue levels and QOL are problematic for patients treated for lung cancer. In an effort to better assist patients and tailor plans of care, it is vital that practitioners, especially nurses, assess for fatigue in advanced lung cancer patients
1 Chapter One Introduction Fatigue is a symptom that every person will experie nce at least once, but usually multiple times during his or her life. In the healthy person, fatigue begins when the individual physically exerts, experiences stress, or lack of sleep, and serves as a protective function by signaling the pe rson to restore energy by resting. A good nightÂ’s sleep or a few hours of re laxation will generally revive a healthy individual to a normal level of functioning (Yarbro, Frogge, & Goodman, 2005). Fatigue as a result of cancer and its treat ments differs from acute fatigue because patients continue to suffer feelings of wea kness and tiredness despite rest (Byar et al., 2006). Fatigue is the most prevalent and distressing sympt om experienced by patients with cancer and undergoing therapy. Indiv iduals with cancer were the first to call fatigue a cancer-related symptom. It is estimated that fatigue is reported by 60 to 100 percent of individuals with c ancer during their course of disease and associated treatment (Yarbro et al., 20 05). This symptom affects 70 to 95 percent of patients receiving chemotherapy, r adiation therapy, or biotherapy and lingers in 17 to 40 percent of disea se-free cancer survivors (Lavdaniti et al., 2006).
2 Fatigue is a multidimensional, subjective experienc e with physiologic, psychological, functional, and social consequences (Donovan & Ward, 2005). The etiology of fatigue is multifactorial in that i t may be related to the disease itself, to sleep disturbance, to concurrent systemi c issues such as anemia or pain, or to emotional distress (Madden & Newton, 20 06). Fatigue is characterized by subjective signs such as feelings of tiredness, muscle weakness, negative mood, loss of alertness, and the perception of interference with daily living activities (Madden & Newton, 2006 ; Yarbro et al., 2005). The objective manifestations of fatigue can include wei ght loss, decreased energy, apathy, anemia, weakness, lack of motivation, decre ased attention, excessive sleepiness, or alterations in sleep patterns (Yarbr o, et al., 2005). Fatigue varies in unpleasantness, duration and intensity (Byar et al., 2006). Lung cancer is the second most common cancer diagno sis and is the leading cause of cancer mortality worldwide. In th e United States, the five-year survival rate across all stages of lung cancer rema ins at approximately 14% and has not changed significantly in several decades. The most common symptoms reported by newly diagnosed lung cancer patients at any stage and for those undergoing therapy for advanced disease are fatigue along with pain, anorexia, insomnia, cough and dyspnea (Tanaka et al., 2002). Given this information, it is vital to improve the quality of life in this patien t population and affect the single most common symptom experienced. Quality of life (QOL) is a multidimensional phenome non that can often be impacted by the experience of living with lung canc er. Lung cancer can
3 positively or negatively influence the physical, so cial, psychological, and spiritual dimensions of daily living. Patients with lung can cer report the greatest amount of psychological stress in comparison with other ca ncer patients. Disturbances in QOL are vital to assess during the entire disease c ontinuum (Sarna et al., 2005). Lung cancer and its associated symptoms have a sign ificant impact on quality of life of those who have the disease. How ever, there has been little research about how gender affects the symptom exper ience of people with lung cancer (Hoffman et al., 2007). According to the Ce nters for Disease Control and Prevention (2007), lung cancer is the second most c ommon cancer among white, black, Asian/Pacific Islander, American Indian/Alas ka Native, and Hispanic men. Lung cancer is the second most common cancer among white and American Indian/Alaska Native women in the United States, an d mortality rates in women are nearly twice that of breast cancer. Lung cance r death rates for U.S. women are among the highest in the world. There has been a progressive swing in lung cancer demographics with a significant increase in women patients in the last two decades (Loevgren et al., 2007). Fu and colleagues (2005) sought to further characte rize the effect of gender on the clinical features and survival patter ns of patients with lung cancer by analyzing data collected from the National Surve illance, Epidemiology, and End Results Database (SEER). They found that women were diagnosed at an earlier age than men, raising the question of gende r-specific differences in susceptibility to carcinogens. However, women stat istically have better
4 outcomes than men at all stages of disease possibly because of hormonal influences. Despite the fact that the demographics of lung canc er are changing from a predominantly male disease, most studies of symptom s and/or quality of life (QOL) are based on Caucasian, middle-income men wit h advanced lung cancer. Some studies have suggested that the symptom experi ences of men and women with lung cancer are different and that women repor t more and a greater intensity of symptoms than men (Loevgren et al., 2007). Also role differences often exist between men and women, which could significantly im pact the perception of intensity of symptoms and greatly affect quality of life. At the 2007 Oncology Nursing Society 32nd Annual Congress, attendees for a special symposium entitled Â“Cancer-Related Fa tigue: The 6th Vital SignÂ” were surveyed about practice patterns in their part icular settings and about their experience in assessing cancer-related fatigue (CRF ). The results revealed that approximately one-third of patients with cancer may not be routinely assessed for fatigue and of those who are assessed for CRF, like ly only half of the acquired information is being documented. The nurses cited barriers to routine assessment of this symptom in their practices as ti me constraints, lack of an appropriate assessment tool, and lack of an appropr iate documentation tool (Given, 2008). Statement of Problem An increasing amount of research is available docum enting the experience of fatigue and its effect on quality of life in women with breast cancer
5 during treatment and in survival phases. Few studi es exist that have examined potential gender differences in the experience of f atigue and perceived impact on QOL in patients with advanced lung cancer receiving chemotherapy. As the goal of palliative chemotherapy is symptom control and a majority of lung cancers are diagnosed in advanced stages, it is imperative that the extent and significance of the fatigue experience be further defined. The pri mary purpose of this study was to measure fatigue levels, characterize the fatigue experience, and assess for gender differences in perceptions of fatigue and QO L in patients with advanced lung cancer receiving chemotherapy. The secondary purpose of this study was to examine practice patterns in the ambulatory sett ing regarding the routine assessment of fatigue. As fatigue is identified as a prevalent and distressing issue in cancer populations, it is important that c linicians are assessing for fatigue and determining to what extent it may be af fecting overall quality of life. Research Questions 1. What are the reported fatigue levels in advance d lung cancer patients who have received a single cycle of chemotherapy? 2. Are there gender differences in the severity, f requency, and total interference of the fatigue experience? 3. Are there gender differences in quality of life in advanced lung cancer patients? 4. How often are providers assessing lung cancer p atients for fatigue and documenting information obtained?
6 5. Which method(s) are utilized to perform fatigue assessment in lung cancer patients? Definition of Terms For the purposes of this study, fatigue and QOL ar e defined as: 1. Fatigue is a multidimensional concept that includes physica l, psychological, social and spiritual aspects and is characterized b y feelings of weakness and tiredness not fully relieved by rest (Byar et al., 2006). 2. Quality of life is defined as a multidimensiona l, intricate concept that blends the physical, functional, psychological, and social well-being of each individual. (Losito et al., 2006). Significance to Nursing Fatigue is a very important concept for healthcare professionals to examine and attempt to understand. Fatigue is a pr oblem that can lead to other physiologic and psychologic symptoms that collectiv ely affect every aspect of a patientÂ’s life and thereby impact overall QOL. St udies have already indicated gender differences in survival rate and susceptibil ity in people with lung cancer. Few studies have defined gender differences in the symptom experiences of people with lung cancer (Hoffman et al., 2007). Th erefore, it is important to elucidate this information as a first step in tailo ring interventions to the particular needs of the defined population. The assessment an d documentation of fatigue levels and recommended management techniques by pra ctitioners is vital to making an impact on this very distressing cancer-re lated symptom.
7 Chapter Two Review of Literature Fatigue is the most frequently reported symptom exp erienced by patients with cancer across the disease continuum. Fatigue is distressing, greatly impacts quality of life, and profoundly effects pat ientsÂ’ abilities to function in routine roles and activities. The severity of the fatigue experience can delay treatments, persist for months or years, and may be predictive of shorter survival in particular cancer populations (Beck, Dudley & Ba rsevick, 2005). Hoffman et al. (2007) noted that few studies have targeted gen der differences in the symptom experiences of patients with lung cancer, a nd the results of the studies have been mixed. Quality of Life and Fatigue In 2001, Okuyama et al. conducted a study to determ ine the prevalence of interference of daily activity due to fatigue in ad vanced lung cancer patients, the correlated factors, and methods to detect at risk p atients. The study accrued 157 subjects with advanced stage or recurrent disease, of which the majority were male, from ambulatory patients at two large academi c centers in Japan. The researchers utilized several instruments to asc ertain the information they were seeking including the Cancer Fatigue Scal e (CFS), the Fatigue Numerical Scale (FNS), and a self-administered ques tionnaire asking if fatigue
8 had interfered with any of seven domains of their a ctivities of daily living. The CFS is a 15-item self-rating scale for assessing fa tigue in cancer patients that consists of three subscales and is modeled to asses s the multi-dimensional nature of fatigue. Items are rated on a Likert-typ e scale with higher scores indicating more severe fatigue. The FNS is a simpl istic tool utilized for assessing fatigue intensity and patients rate their fatigue e xperience on an 11-point scale. The investigators also assessed a broad range of bi opsychological factors, including cancer information and previous history o f anti-cancer therapy, psychological distress, and demographical and socia l support status using medical record data, a self-administered questionna ire, and structured interview (Okuyama et al., 2001). The investigators found that 81.5% of patients expe rienced some degree of fatigue and that one-third of patients reported that fatigue had interfered with physical activities such as walking or normal work. One fifth of the patients reported that fatigue had interfered with emotional activities such as mood or enjoyment of life and half of the patients were fou nd to have clinical fatigue. Depression was also found to be a correlated factor for fatigue (Okuyama et al., 2001). Limitations of this study are the lack of g ender representation and therefore, lack of ability to generalize results to entire population of advanced lung cancer patients. Tanaka and colleagues (2002) investigated how often fatigue, dyspnea, and pain interfered with daily living activities, w hether any differences existed in the characteristics of these symptoms regarding imp act on daily life activities,
9 and whether an 11-point numerical scale was appropr iate for screening for those symptoms interfering with at least one daily life a ctivity in ambulatory patients with advanced lung cancer. The study accrued 171 p atients and again a majority of the patients were male. Subjects were recruited from ambulatory lung cancer clinics in two large academic centers in Japan. The researchers utilized a questionnaire to be comp leted by the subjects at home and then returned in the mail. If any item s were left blank, telephone inquiry was used to obtain missing data. The sever ity of dyspnea, pain, and fatigue were evaluated with an 11-point numerical s cale with the higher the rating correlating with a greater symptom distress. Anoth er questionnaire, which was a modified version of the Brief Fatigue Inventory (BF I), was used to assess the impact of the three symptoms on daily living activi ties in the previous 24 hours. The responses were either Â“presenceÂ” or Â“absenceÂ” o f interference. Demographic information and medical information wer e obtained from medical record review (Tanaka et al., 2002). The investigators found that fatigue interfered wit h at least one daily life activity in 52% of subjects and mood and enjoyment were disturbed in approximately 20% with fatigue rated as severe as a seven. Dyspnea interfered with at least one daily life activity in 55% of sub jects, but subjects did not experience as significant a disturbance in mood and enjoyment. Limitations of the study were that 74% of subjects had an Eastern Cooperative Oncology Group Performance Status (ECOG PS) of one, which is slightly higher than most
10 patients in this population, and the tools utilized were not properly validated and confirmed (Tanaka et al., 2002). Brown, McMillan, and Milroy in 2005 sought to explo re the relationship between fatigue, physical function, the systemic in flammatory response, and psychological distress in patients with advanced lu ng cancer. The study accrued a total of 55 patients, 38 lung cancer patients and 15 healthy subjects. Of the 38 lung cancer patients, 23 were men and 15 were women The lung cancer patients were those diagnosed with locally advanced or metastatic disease and recruited from two specialty palliative care center s and an associated hospital in the United Kingdom. The healthy volunteers were ag e-matched and gendermatched. The control group and patient group were assessed f or fatigue, weakness, anthropometry, physical function, and psychological distress and several questionnaires were utilized to assess fatigue, wea kness, and psychological distress. The authors used the Functional Assessme nt of Chronic Illness Therapy-Fatigue scale (FACIT-F) to measure fatigue and this tool is a 13-item subscale of the FACIT-F questionnaire that has subj ects score each item on a zero to four scale (not at all to very much). A lo w total score represents a high level of fatigue. The subscale assesses quality of life in cancer patients experiencing fatigue and other anemia-related sympt oms. Weakness was measured using a simple 10-cm visual analogue scale which ranged from Â“I donÂ’t feel weak at allÂ” to Â“I couldnÂ’t feel any weakerÂ”. Psychological distress was measured using the Hospital Anxiety and Depression (HAD) scale and this is a
11 14-item self-report questionnaire intended to measu re anxiety and depression. The subjects were asked to score the answer that ca me closest to how they had been feeling in the previous week on a scale of zer o to three with a higher score suggestive of psychological distress (Brown, McMill an & Milroy, 2005). The results revealed that patients with advanced lu ng cancer had higher levels of weakness and fatigue and increased psycho logical distress as compared to the control group. The authors subdivi ded the group of cancer patients on the basis of fatigue and found that fat igue was clearly associated with poor physical function and more psychological distr ess (Brown, McMillan & Milroy, 2005). The comparison to the healthy popul ation was interesting, however, likely not necessary as it is intuitive th at the cancer population will report more symptoms and higher severity scores. Dagnelie and colleagues. (2007) conducted a crosssectional study to quantify the impact of fatigue, relative to other Q OL domains, on overall QOL in lung and breast cancer patients preceding curative radiotherapy. Their interest derived from lack of studies on this issue. The st udy accrued a total of 64 patients with 100% of the breast cancer patients be ing women and 45% of the lung cancer patients being women. The investigators used the European Organization fo r Research and Treatment of Cancer Quality of Life Questionnaire ( EORTC QLQ-C30) which is a 30-item cancer-specific core questionnaire that con tains five function subscales, three symptom subscales, and two single items asses sing global health and Â“overallÂ” QOL, and a number of single items address ing various symptoms and
12 believed financial impact. Subjects were asked to complete the EORTC QLQC30, as well as a demographic profile, prior to beg inning radiotherapy (Dagnelie et al., 2007). The investigators found that EORTC QLQ-C30 scores r evealed considerable impairment in global health status and overall QOL, especially in lung cancer patients. Also, significant impairment was noted for the subscales physical, role and emotional functioning, and for t he symptom subscales fatigue, dyspnea, pain, insomnia, and appetite loss. Lung c ancer patients reported being significantly more tired than breast cancer patient s. There was a distinct correlation between level of fatigue and perceived overall QOL (Dagnelie et al., 2007). A limitation of this study is the inability to generalize these results into advanced stages of lung cancer as the subjects in t his trial were receiving curative radiotherapy. Bozcuk and colleagues in 2006 were interested in ex ploring disease and treatment factors that can affect QOL that have not previously been thoroughly investigated in patients with metastatic non-small cell lung cancer receiving chemotherapy. The study acquired 50 patients with 46 men and only 4 women. Thirty-seven of the patients were receiving first l ine chemotherapy and thirteen were receiving second line. All subjects had eithe r unresectable stage three or stage four disease and were seen in ambulatory medi cal oncology clinics. The authors also utilized the EORTC QLQ-C30 questio nnaire to assess the various aspects of QOL. The questionnaire was completed prior to the first cycle, on day seven, and after the completion of th e second cycle. The
13 investigators gathered demographic, disease, and tr eatment data from medical record review (Bozcuk et al., 2006). The study results proved quite interesting. The au thors found that baseline QOL affects the change in QOL on chemother apy in that those patients with a starting global QOL score less than or equal to 50 saw an increase in global QOL and physical functioning and a decrease in fatigue after two cycles of chemotherapy. Conversely, those patients with a st arting global QOL score greater than 50 saw a decline in global QOL and phy sical functioning, but an increase in fatigue. Also, patients receiving seco nd line chemotherapy reported less fatigue while on chemotherapy than those patie nts receiving first line chemotherapy (Bozcuk et al., 2006). A definite lim itation of this study was the few number of women represented in the study sample Gender and Fatigue Sarna and Brecht (1997) performed an exploratory st udy, combining two studies of women with advanced lung cancer, with th e purpose of investigating the underlying cluster of distressing symptoms expe rienced by women with advanced lung cancer and exploring the differences in symptoms among clinical and demographic variables. The study looked at a c ombined total of 60 women accrued in oncology clinics, private practices, and oncology units. Forty were from a previous descriptive study looking at women with any stage of disease and twenty were from a current longitudinal trial l ooking at women with advanced stage lung cancer. The authors performed a seconda ry analysis of the forty women from the previous study. The women ranged in age from 33 to 80 years,
14 were eight-seven percent Caucasian, the majority we re married and had nonsmall cell lung cancer in advanced stages. The Symptoms Distress Scale (SDS) is a 10-item self -report scale developed for assessing cancer-related symptoms, bu t for this study was modified to include 13 items pertinent to lung canc er patients. Items are reported on a Likert-type scale with rates from one to five and five represents the most distress. Clinical variables assessed included phy sical function, presence and mode of treatment, presence of distant metastases, smoking status, and presence of comorbid disease which was obtained fro m Karnofsky Performance Status rating and medical record data. Demographic variables included race or ethnicity, age, marital status, employment status, income, and education which were collected from a demographic form completed by the patients (Sarna & Brecht, 1997). Sarna and Brecht (1997) found that fatigue, negativ e outlook, frequent pain, and insomnia were the most prevalent and the most seriously rated symptoms. There were no differences reported in sy mptom distress by the presence of distant metastases, comorbid disease, h istologic type of lung cancer, marital status, education, income, or smoking statu s. Limitations of this study were small sample size in that essentially only 20 women were actively evaluated by the study instrument and lack of comparison of w omen to men to ascertain whether there were gender differences in symptom ex perience. Sarna et al. in 2005 conducted a prospective, cross -sectional, descriptive study to describe the quality of life (QOL) in wome n living with non-small cell lung
15 cancer, describe the characteristics of meaning of illness (MOI), and explore the demographic, clinical, health status, and MOI corre lates of QOL. The study collected data from 217 women, predominantly Caucas ian, recruited from multiple clinical sites in the western, eastern, an d southern regions of the United States. All study participants had been diagnosed at least six months and less than five years with non-small cell lung cancer. The investigators utilized several instruments incl uding the QOL ScalePatient Version (QOL-Patient) and the Short Form-36 Item (SF-36). The QOLPatient is a 41-item questionnaire that was used in this study as a cancer-specific measure of QOL. Each item uses a Likert-type scale on an 11-point range and consists of four subscales addressing physical, soc ial, psychological, and spiritual well-being. Subjects responded to questi ons based on how their cancer experience affected their quality of life. The SF36 was used as a generic measure of health-related QOL and is a 36-item self -report questionnaire that evaluates physical functioning, bodily pain, role l imitations caused by physical health, role limitations caused by emotional health emotional well-being, social functioning, vitality and fatigue, and general heal th perceptions. Scores range from 0 to 100 one each subscale and higher scores i ndicate better QOL. Meaning of illness (MOI) was assessed using eight c ards with individual statements describing illness in positive or negati ve terms. All eight cards were placed in front of the subject at one time and the subject was asked to choose the card the most represented her view of her illne ss. The investigators also
16 collected data on health status, depressed mood, de mographics, and clinical variables (Sarna et al., 2005). The researchers found that women reported serious l evels of fatigue, substantial disruptions in psychological well-being and a strong relationship between health status and physical QOL. One limita tion of the study was that of the 217 subjects accrued, 184 were Caucasian, there by making it difficult to generalize to all the population of women with lung cancer. The investigators did only include those subjects with non-small cell lun g cancer; however, this is of little consequence as the majority of patients with lung cancer have this histologic type (Sarna et al., 2005). Hoffman et al. (2007) studied the relationships am ong pain, fatigue, insomnia, and gender while controlling for age, com orbidities, and stage of cancer. The study was a secondary analysis of a si ngle-blinded, randomized clinical trial of people with cancer sponsored by t he National Cancer Institute and the National Institute for Nursing Research and the researchers selected only data on lung cancer patients obtained from the firs t interview at the time of entry into the trial. Participants were accrued from two community oncolo gy programs and two comprehensive cancer centers. The analysis was completed on 80 patients ranging from age 41 to 83 years and mostly married Caucasians. The analysis was divided nearly even at 55% men and 45% women (H offman et al., 2007). The participants were exposed to a 10-session nursi ng intervention that lasted 20 weeks. Symptoms were assessed utilizing the Cancer Symptom
17 Experience Inventory which is a self-report instrum ent of 15 symptoms related to cancer or its treatment. For this study, the varia ble assessing the frequency of fatigue, pain, and insomnia was dichotomized to mea sure the duration of the relationships among fatigue, pain, and insomnia in people with a new diagnosis of lung cancer with 56 days of receiving chemothera py. Symptoms were rated on a scale from 0 to 10 with 10 indicating the grea test severity. Comorbidities were assessed using a modified version of the Comor bidity Questionnaire which assessed for the presence or absence of 14 various chronic health conditions (Hoffman et al., 2007). The investigators found that there were no gender d ifferences in fatigue reporting, with 98% of men reporting fatigue and 94 % of women reporting fatigue. Of the three symptoms of interest to the authors, the only symptom reported with higher levels of severity for women t han men was insomnia. Limitations of this study were that it was a second ary analysis and that it was difficult to ascertain whether the symptoms address ed were related to disease and treatment or to comorbidities (Hoffman et al., 2007). Husain et al. in 2007 explored sex differences in f atigue at the end of life. The investigators hypothesized that a sex differenc e in fatigue exists and that sex-specific correlates lie beneath this difference The study was a three-month longitudinal study that accrued subjects from a hom e palliative care program serving a major urban center. Patients had to be a dmitted to the palliative care program to be eligible to participate and were excl uded if under the age of 18 and if cognitively impaired.
18 The study accrued a total of 102 patients with a fa irly equal representation of each sex 47 men and 55 women. The participant s completed questionnaires at zero, one, three, five, seven, nine, and eleven weeks and the disposition of patients were followed for 12 months after completi on of the study. The investigators utilized the Brief Fatigue Inventory (BFI) which is a nine-item, selfreport, symptom severity and functional interferenc e scale. The tool measures the single domain of fatigue severity and a score o f greater than 3 was used as a discontinuance point to identify moderate to severe fatigue. The investigators also utilized the McGill Quality of Life (MQOL) Que stionnaire which is a multidimensional tool that measures physical, psych ological, support, and existential domains. Scores are reported from 0 to 10 and higher scores correlate with better QOL (Husain et al., 2007). The authors of the study found that the prevalence of moderate to severe fatigue at week zero and over time was significantl y higher in women than in men. Interestingly, no differences in MQOL scores were found between the sexes. This study was the first such study documen ting that women experience a higher prevalence of fatigue and a marked fatigue severity, at least in the setting of advanced illness receiving palliative ca re at home. A limitation of this study was that it did not elucidate specific cancer diagnosis and therefore, did not account for specific cancer treatments (Husain et a l., 2007) Loevgren et al. (2007) initiated a study to examine the prevalence and severity of symptoms and difficulties with function ing in women and men with inoperable lung cancer. The study looked at these issues at three points close to
19 diagnosis, the extent to which these issues change over time, and patient characteristics that influence these issues. Loevg ren et al. (2007) analyzed data generated from 159 patients, 70 women and 89 men, w ho had completed the EORTC QLQ-C30+ Lung Cancer13 (LC13) at baseline (T1 ), 1 month (T2), and 3 months (T3) after T1. The EORTC QLQ-C30 + LC13 is a self-report health-re lated QOL instrument that assesses general aspects of healthrelated QOL through 30 items consisting of five functional scales, three s ymptom scales, a global health status/QOL scale, and several single items such as dyspnea and insomnia. The LC13 module assesses disease-specific symptoms, tre atment-related side effects, and pain medication. Each item is evaluat ed on a four-point Likert scale except for the global health status/QOL items and t hese have responses that range from Â“very poorÂ” to Â“excellentÂ”. However, th e global health/QOL scale was not used in this study (Loevgren, 2007). The study revealed that the most prevalent symptoms and difficulties with functioning were associated with fatigue at all tim e points for both women and men. However, significantly more women than men re ported Â“feeling tenseÂ”, Â“worriedÂ”, Â“depressedÂ” and more limited in work/dai ly activities at baseline and also reported that at T1, their physical condition or treatments interfered with their social activities and at T3, they needed to stay in the bed or in a chair for most of the day. One limitation of this study was the smal l sample size, but it is difficult to accrue a large sample of lung cancer patients to th ese studies as this group is
20 typically severely ill and non-random attrition and non-participation is a significant barrier to accrual (Loevgren et al., 2007). Fatigue Assessment Regarding routine assessment of fatigue by clinicia ns, several studies have sought to identify potential barriers from the patient, clinician, and system perspectives. In 2002, Passik et al. conducted a c linical trial to explore patientrelated barriers to communication about fatigue acc ording to the patient perspective. The study recruited 200 subjects equa lly from multiple urban and rural sites in the Community Cancer Care, Inc. netw ork in Indiana. The investigators utilized the 28-item self-report Fati gue Management Barriers Questionnaire (FMBQ) and found that 46.7% of the su bjects reported that interventions for fatigue were not being offered as well as 43.1% stated that they were unaware of any possible treatments for fatigue This led the investigators to conclude that physicians and patients seem to have reservations discussing fatigue as a symptom of the disease and as a conseq uence of therapy. Borneman et al. (2007) reported data on the phase o ne portion of a three phase five year prospective National Cancer Institu te (NCI) funded clinical trial seeking to translate the National Comprehensive Can cer Network (NCCN) Cancer-Related Fatigue Clinical Practice Guidelines in Oncology into practice and construct a translational interventional model that can be reproduced across other settings. Phase one of the study examined fa tigue-related patient, professional, and system barriers that hinder routi ne use of NCCN guidelines recommendations.
21 The trial recruited 69 patients with a known diagno sis of breast, lung, colon or prostate cancer from one medical oncology adult ambulatory care clinic at a NCI-designated comprehensive cancer center in Southern California. A chart audit was conducted to evaluate practitioner practices. The audit revealed a lack of adherence to guidelines, documentation of fatigue, and referrals for supportive care. Of note, the greatest adherence w as documented for assessment of anemia at 28.99%. A significant numb er of the patients (66%) reported that they had never discussed their compla ints of fatigue with their physician and the prevailing belief (54%) was if fa tigue was important, then the physician would have initiated conversation on this subject. (Borneman et al., 2007) Knowles et al. (2000) conducted a survey study of r egistered nurses working with the Department of Clinical Oncology at the Cancer Centre in Edinburgh, UK. The investigators wished to evaluat e nursesÂ’ knowledge of fatigue, assessment practices, and what interventio ns they employed to address patient complaints of fatigue. The study revealed that cancer-related fatigue was identified as a common symptom experienced by a maj ority of the patients the respondents cared for and 75% of the respondents re ported that they assessed for fatigue in their patient population. However, the study did not delineate the methods and depth of fatigue assessment and whether assessment of fatigue was routinely performed. Of note, nurses utilizing common grading criteria were more likely to work with patients enrolled on clini cal trials. Summary
22 From the review of literature, many of the studies exploring fatigue, symptom distress, and impact on quality of life in women with lung cancer specifically were conducted in the 1990s, and the s tate and rigor of treatment modalities, even palliative, has changed since that time. The majority of current studies examining this population have largely not been conducted in the United States so results are not necessarily generalizable to our population of women who may have different roles and concerns. Suffici ent studies exist to explore the issue of fatigue and quality of life in the gen eral lung cancer population, however, most of the participants in these trials w ere men, rendering the results not clearly applicable to women. Loevgren et al. ( 2007) speculates that a lack of knowledge about differences in symptom experiences between men and women may impede appropriate intervention from the health care system. Also noted, was a lack of trials with any interventions to addr ess fatigue and thereby impact quality of life in this patient population. Studies suggest that there are many barriers that h inder systematic assessment, management, and documentation of cancer -related fatigue. In an effort to breakdown these barriers, further studies of the patterns of clinician and nursing assessment of fatigue need to be completed.
23 Chapter Three Methods The purpose of this study was to measure fatigue le vels, characterize the fatigue experience, and assess for gender differenc es in perceptions of fatigue and quality of life (QOL) in patients with advanced lung cancer receiving chemotherapy. The secondary purpose of this study was to examine practice patterns in the ambulatory setting regarding the ro utine assessment of fatigue. This chapter delineates the sample, measurement too ls, and procedures utilized to facilitate obtaining the information sought by t he researcher. The chapter ends with a description of data analysis. Setting and Sample This study was a secondary analysis of a larger stu dy that was already underway in the ambulatory care clinics of a large, National Cancer Institutedesignated comprehensive cancer center. This large r study had accrued over 300 patients at the time of this study and sought t o examine the impact and relationships of stress management and exercise tra ining on QOL during chemotherapy treatment. Data on fifty subjects, 25 women and 25 men, all with advanced lung cancer, was extracted and examined to achieve a representative sample of each gender to assess for any differences in fatigue severity, frequency, total interference and QOL. Participant s were 18 years of age or
24 older; capable of speaking and reading standard Eng lish; diagnosed with advanced lung cancer; had not received intravenous chemotherapy administration in the last two months; were schedul ed to receive cytotoxic chemotherapy as outpatients at the center over a pe riod of at least 14 weeks; had an ECOG performance status of zero, one, or two ; and were able to provide informed consent. Instrumentation Short-Form 36 (SF-36) Acute Version 1 The SF-36 is a multi-purpose, short-form health sur vey questionnaire consisting of 36 items. It is a self-report measur e designed to assess perceived health and functioning and contains eight scales: t en physical functioning items, two social functioning items, four role limitations due to physical problems items, three role limitations due to emotional problems it ems, five mental health items, four energy and vitality items, two pain items, and five general perceptions of health items. Each scale uses a variety of rating formats and raw scores are converted to a standard metric. Subjects provide L ikert-type responses to questions regarding perceived ability to complete a ctivities of daily living. Each item is scored on a scale from 0 to 100 with 0 repr esenting the worst possible health state and 100 representing the best possible health state (Jenkinson et al., 1993). The interrelatedness of the psychosocial an d functional dimensions of QOL is correlated with physical functioning, and ps ychosocial aspects are measured in terms of social activities and relation ships (Losito et al., 2006)
25 Reliability and validity. The SF-36 has subscale reliability coefficients ranging from 0.76 to 0.93. Content validity and co nstruct validity have been supported in multiple QOL studies (Ware et al., 200 2; Losito et al, 2006) Fatigue Symptom Inventory (FSI) The FSI is a 14-item self-report tool that assesses the severity, frequency, and daily pattern of fatigue, as well as its percei ved interference with performance. Four items measure severity on separa te 11-point scales that assess most, least, and average fatigue in the past week as well as current fatigue. Frequency is measured utilizing two separ ate items that assess the number of days in the past week that fatigue was fe lt as well as the extent of each day on average fatigue was felt. Perceived in terference is measured on seven separate 11-point scales that assess the degr ee to which fatigue in the past week was judged to interfere with general leve l of activity, ability to bathe and dress, normal work activity, ability to concent rate, relations with others, enjoyment of life, and mood. Interference ratings can be added to obtain a total perceived interference score. The final item is a diurnal variation measured using a single item that provides descriptive infor mation about daily patterns of fatigue (Jacobsen, 2004). Reliability and validity. The FSI is an established reliable and valid measurement tool of fatigue in patients with cancer The CronbachÂ’s alpha coefficient ranges from 0.92 to 0.95, with converge nt validity supported by significant correlations with the Profile of Mood S tates-Fatigue (POMS-F).
26 Construct validity was supported by significant cor relations with life satisfaction and depression (Hann et al., 2000). Demographic Data Form Demographic data was gathered from existing self-re port and medical record review information collected during enrollme nt of the subjects. Data extracted for this study included age, gender, hist ology, stage of disease, ECOG status, whether treatment included radiotherapy and /or biologic therapy, previous chemotherapy, marital status, ethnicity, race, educ ational status, employment status, occupations of both subject and spouse, and net household income. Chart Audit Form A chart audit form was developed to track provider assessment and documentation of fatigue levels for the 50 subjects examined in this study. Also, method of assessment utilized was assessed. Charts were reviewed for use of any of the five most common tools of fatigue level assessment: a four-point verbal rating scale (none, mild, moderate, severe); a five-point verbal rating scale (none, mild, moderate, severe, very severe); an ele ven-point numeric scale (0 is no fatigue and 10 is worst possible fatigue); a fou r-point numeric scale (Common Toxicity Criteria of the National Cancer Institute) ; and a 10cm visual analogue scale (no fatigue to worst possible fatigue). If p resent in the documentation, data was appropriately recorded. Institutional Approvals Approval to conduct the larger study had already be en obtained from the Scientific Review Committee (SRC) of the institutio n from which the subjects
27 were accrued and the University of South Florida In stitutional Review Board (IRB). Both entities are in existence to evaluate the validity of a study and to protect the welfare of any human subjects who chose to participate in this study. An amendment to the original study was drafted to i nclude the chart audit that assessed provider practice patterns of assessment a nd documentation of fatigue levels and was approved by the University of South Florida IRB. Procedures With assistance from the researchers conducting the larger study, the existing database was queried for an equal number o f female and male subjects with advanced lung cancer who had received at least one cycle of chemotherapy. The subjectsÂ’ FSI and SF-36 questionnaire scores at 5 to 6 weeks after a single cycle of chemotherapy, as well as pertinent demogra phic data, were gathered. Also, the medical record was reviewed for physician and nurse documentation of fatigue levels and methods of assessment on the bas eline office visit and the first follow-up visit after a single cycle of chemotherap y. Data Analysis Descriptive statistics were used to analyze the dem ographic data including frequencies, percentages, means, and standard devia tions. Gender differences in fatigue levels and QOL scores were analyzed for statistical significance utilizing t-tests. Categorical data regarding the absence or presence of fatigue assessment by the physician and nurse was analyzed utilizing frequencies and percentages.
28 Chapter Four Results, Discussion and Conclusions This chapter presents the findings of the study. Included in this chapter are the results, discussion of the findings and lim itations, conclusions, and recommendations for future research. Results The sample consisted of 50 total subjects, 25 wome n and 25 men. They ranged in age from 40 to 80 with a mean age of 62.4 (SD=10.1). Of the sample, 64 percent were married and 30 percent were divorce d. The majority of the participants were white, representing 48 of 50 pati ents. Nearly half of the subjects reported some college education or special ized training while a quarter reported a high school graduate level of education (Table 1). Table 1 Frequency and Percent of Sample Demographic Charact eristics Variable Frequency Percent Male 25 50.0 Gender Female 25 50.0 Currently 32 64.0 Divorced 15 30.0 Never 2 4.0 Marital Status Widowed 1 2.0 White 48 96.0 Black/African American 1 2.0 Race More Than 1 Race 1 2.0 Partial High School (10th & 11th) 2 4.0 High School Graduate 12 24.0 Partial College or Special Training 21 42.0 College or University Grad 8 16.0 Education Graduate Degree 7 14.0
29 The majority (n=22) of subjects were retired. Hous ehold incomes were fairly evenly distributed across a range from $20,0 00 up to greater than $100,000, with nine patients preferring not to resp ond to this particular demographic question (Table 2). Table 2 Frequency and Percent of Employment Status and Hous ehold Income Variable Frequency Percent Retired 22 44.0 Full-time Job 7 14.0 Part-time Job 6 12.0 On leave w/ pay 6 12.0 On leave w/o pay 5 10.0 Employment Disabled 4 8.0 Less than $10,000 5 10.0 $10,000-$19,999 4 8.0 $20,000-$39,999 10 20.0 $40,000-$59,999 6 12.0 $60,000-$100,000 9 18.0 > $100,000 7 14.0 Household Income Prefer Not to Answer 9 18.0 All of the subjects in this sample had lung cancer (n=50). Of the 50, 26 patients had Stage IV non-small cell lung cancer, 1 4 had stage III non-small cell lung cancer, five had limited stage small cell lung cancer, and five had extensive stage small cell lung cancer. Approximately one-th ird of the patients had an ECOG performance status of 0 and two-thirds had an ECOG of one. The majority of patients were receiving chemotherapy al one, with only nine receiving radiation in addition to chemotherapy and nine rece iving biotherapy in addition to chemotherapy. Forty-five subjects had never had ch emotherapy before while five had prior chemotherapy experience (Table 3).
30Table 3 Frequency and Percent of Disease and Planned Concur rent Therapy Variable Frequency Percent Type of Ca Lung 50 100.0 1 32 64.0 ECOG PS 0 18 36.0 IV NSCLC 26 52.0 III NSCLC 14 28.0 Stage Ltd. SCLC 5 10.0 Ext.SCLC 5 10.0 Receiving Radiation Yes 9 18.0 Receiving Biotherapy Yes 9 18.0 Previous Chemotherapy Yes 5 10.0 Fatigue Symptom Inventory (FSI) Levels, severity, frequency, and total interferenc e of fatigue were assessed utilizing the FSI self-report questionnair e. Overall fatigue was reported with a mean of 5.9 (SD=3.0) for the highest level i n the past week and a mean of 2.1 (SD=1.9) for the lowest level in the past week. Subjects reported that fatigue occurred with a mean of 4.7 days in the past seven days. Fatigue was reported to have been present at a mean of 4.5 hours (SD=3.1 ) per day (Table 4). Men reported the highest level of fatigue with a me an score of 6.4 (SD=3.1) and the lowest level with a mean of 2.4 (S D=2.0) in the week preceding the completion of the questionnaire. Women reporte d the highest level of fatigue with a mean score of 5.4 (SD=3.0) and the lowest le vel with a mean of 1.9 (SD=1.7). Frequency data revealed that out of one week, men reported fatigue with mean scores of 4.8 days and women with mean sc ores of 4.6 days (Table 4).
31 The overall, total interference scores revealed a m ean of 20.3 (SD=19.9). The rate that fatigue interfered with levels of act ivity was reported as a mean of 3.9 (SD=3.7). Fatigue interfered with enjoyment of life with mean scores of 3.3 (SD=3.1) and with enjoyment of life with reported m ean scores of 3.3 (SD=3.1). Among the gender specific interference scores, fati gue interfered the most with levels of activity with a mean of 4.4 (SD=4.3) in m en and a mean of 3.3 (SD=3.0) in women. Fatigue interfered least with ability to bathe and dress self with men reporting a mean of 1.5 (SD=3.0) and women reportin g a mean of 1.0 (SD=1.3) (Table 5). There were no significant differences in scores between women and men. Table 4 Means and Standard Deviations (SD) with Independent t-test Comparison of Severity and Frequency Items on the FSI Questionnaire Fatigue in past week mean SD t p Overall 5.9 3.0 Male 6.4 3.1 Highest level Female 5.4 3.0 1.212 .231 Overall 2.1 1.9 Male 2.4 2.0 Lowest level Female 1.9 1.7 .981 .332 Overall 4.0 2.5 Male 4.4 2.6 Average level Female 3.6 2.3 1.192 .239 Overall 3.0 2.7 Male 3.6 3.1 Level now Female 2.5 2.2 1.430 .160 Overall 4.7 2.5 Male 4.8 2.6 How many days Female 4.6 2.5 .279 .782 Overall 4.5 3.1 Male 5.2 3.3 How much of the day on average Female 3.8 2.7 1.544 .130
32 Table 5 Means and Standard Deviations (SD) with Independent t-test Comparison of Interference Items on the FSI Questionnaire Fatigue in past week Mean SD t p Overall 3.9 3.7 Male 4.4 4.3 .274 Rate interfered with level of activity Female 3.3 3.0 1.107 .275 Overall 1.2 2.3 Male 1.5 3.0 .393 Rate interfered with ability to bathe and dress self Female 1.0 1.3 .862 .395 Overall 3.6 3.5 Male 3.8 3.9 .688 Rate interfered with normal work activity Female 3.4 3.1 .404 .688 Overall 2.7 3.1 Male 3.0 3.4 .503 Rate interfered with ability to concentrate Female 2.4 2.8 .675 .503 Overall 2.5 3.0 Male 3.0 3.4 .267 Rate interfered with relations with other people Female 2.0 2.6 1.122 .268 Overall 3.3 3.1 Male 3.9 3.6 .195 Rate interfered with enjoyment of life Female 2.8 2.6 1.313 .196 Overall 3.0 3.2 Male 3.6 3.7 .288 Rate interfered with mood Female 2.6 2.5 1.075 .288 Short-Form-36 (SF-36) Quality of life was measured utilizing the SF-36 h ealth survey instrument. Overall physical functioning revealed a mean score of 54.9 (SD=29.7). The overall mean score for physical role limitations wa s 34.5 (SD=42.2) and vitality 35.1 (SD=24.2). Both were below the midpoint indic ating lower states of health. The remaining mean scores were nearing or above the midpoint indicating average to better states of health (Table 6). Again, no significant gender differences were noted in quality of life measures. Lower scores on this instrument represen t a worse state of health and higher scores represent a better state of healt h. Overall, physical functioning
33 was the most affected of the eight domains measured by the SF-36. Men reported mean scores of 48.6 (SD= 31.2), while wome n reported mean scores of 61.2 (SD=27.2). Of the eight scales, bodily pain w as reported similarly among this sample with a reported mean score of 69.5 (SD= 31.1) in men and 69.9 (SD=26.0) in women (Table 6). Of note, women repor ted better states of health than men, but this did not prove to be statisticall y significant upon analysis. Table 6 Means and Standard Deviations (SD) with Independent t-test Comparison of Items on the SF-36 Questionnaire Variable Mean SD t p Overall 54.9 29.7 Male 48.6 31.2 Physical Functioning Female 61.2 27.2 -1.522 .135 Overall 34.5 42.2 Male 31.0 41.0 Role Limitations Â– Physical Female 38.0 44.0 -.582 .563 Overall 68.7 42.8 Male 62.7 45.5 Role Limitations Â– Emotional Female 74.7 40.0 -.991 .327 Overall 35.1 24.2 Male 30.8 23.9 Vitality Female 39.4 24.2 -1.265 .212 Overall 72.0 24.2 Male 68.0 29.8 Mental Health Female 76.0 16.5 -1.174 .246 Overall 64.0 29.2 Male 59.0 31.1 Social Functioning Female 69.0 26.8 -1.217 .230 Overall 69.7 28.4 Male 69.5 31.1 Bodily Pain Female 69.9 26.0 -.049 .961 Overall 45.9 19.3 Male 43.7 18.2 General Health Female 48.1 20.4 -.815 .419 Chart Audit Form For each of the 50 subjects, physician and nursing documentation was reviewed at baseline visit and at first visit after chemotherapy for documentation
34 of presence of fatigue and method utilized to asses s and define fatigue. Physician documentation of fatigue was noted to occ ur at a rate of 33% and nurses at a rate of 21%. The two tools employed by practitioners to assist in screening for fatigue were the four-point verbal ra ting scale and the four-point numeric scale. Discussion Demographic Data Data on the subjects was extracted from a much larg er study currently being conducted in the ambulatory care clinics of a large, National Cancer Institute-designated comprehensive cancer center. The sample consisted of an equal number of middle-class, white women and men. All of the participants had advanced lung cancer and were receiving chemotherap y. Few of the subjects were receiving concurrent radiation therapy or biot herapy so the results are not reflective of more vigorous therapy. Also, few of the patients had received prior chemotherapy so the results are not generalized to those patients who have received other lines of therapy. All of the subjects participating on the study had an ECOG PS of zero or one. An ECOG PS of zero indicates no symptoms and a one indicates minimal symptoms. The study prohibited patients with an EC OG performance status of greater than two from participating. Many patients with advanced stages of lung cancer and a Performance Status two are eligible fo r palliative chemotherapy and likely the results are not representative of fa tigue levels and quality of life in this population. The sample was small, predominant ly white and gathered from a
35 single geographic area; thus, results may not be ge neralizable beyond this sample. Fatigue Symptom Inventory (FSI) Although the results of this study did not reveal a statistical significance in the severity, frequency, interference, or patterns of fatigue scores among the male and female participants, it did reveal some im portant findings. For the highest level of fatigue in the past week, men and women reported moderate levels of fatigue. Men and women reported fatigue on nearly 5 out of 7 days in the past week. Fatigue, in both genders, interfere d mostly with activity levels. Male participants scored the 14-item fatigue measur es consistently higher than female participants. The rate that fatigue in terfered with enjoyment of life in the past week item revealed a mean score of 3.9 (SD =3.6) for the male subjects versus 2.8 (SD=2.6) for the female subjects. The r ate that fatigue interfered with relationships with other people and with mood in th e past week showed mean scores of 3.0 (SD=3.4) and 3.6 (SD=3.7) for the mal e participants respectively, while the mean scores for the female participants w ere 2.0 (SD=2.6) and 2.6 (SD=2.5) respectively. A limitation of this study was that fatigue was mea sured after the completion of a single cycle of chemotherapy. Fati gue tends to be cumulative over the course of multiple cycles of chemotherapy. The scores derived in this study are likely not reflective of the severity, fr equency, interference and patterns of fatigue patients experience with receiving more than one cycle of chemotherapy. Also, a majority of the patients on the study were receiving
36 chemotherapy alone and for those receiving concurre nt radiation therapy or biotherapy, fatigue may be amplified. SF-36 Overall, the subjects reported average to better st ates of health on the items of this measurement tool. Physical role limi tations and vitality scores were reported below midpoint and indicated perceived les ser states of health. The study results did not confirm statistically sig nificant gender differences in quality of life measures. Again, male participa nts scored all items of the SF-36 lower than female participants. Physical functioni ng appeared to affect health scores in men more so than women. Men and women re ported similar states of health for the physical role limitations and bodily pain items. Both reported states of health below midpoint for physical role limitati ons and states of health above midpoint in relation to effect of bodily pain. Fatigue assessment As fatigue is the most prevalent and most distress ing symptom reported by advanced lung cancer patients, the need for cons istent assessment is imperative. There are well-established interventio ns to address the issue of fatigue in cancer patients. Interventions to impac t or alleviate fatigue cannot be employed if fatigue is not assessed. Significant f atigue can lead to patients suffering in silence or ceasing therapy prematurely While assessment of fatigue may be routinely perfor med by practitioners during office visits, the documentation examined in this study does not reflect this practice. Physicians did document patientsÂ’ report s of fatigue more often than
37 nurses; however, rates of documentation were still quite low. Both practitioners utilized the fourpoint verbal rating scale more f requently than other methods of fatigue assessment. Several nurses utilized the fo ur-point numeric rating scale; however, it should be noted that many of the subjec ts were on a concurrent chemotherapy trial and data in this format was requ ired to document toxicities. It is unknown, since symptoms tend to occur in cluster s, if other symptoms such as pain or nausea and vomiting supersede the assessmen t and documentation of fatigue in daily practice. The sample examined was small and all the subjects were recruited from a single ambulatory clinic. Implications for Nursing Fatigue and quality of life (QOL) are critical con cepts for nurses to seek to understand. Although this study did not establish statistically significant gender differences in fatigue and QOL, it did reveal that fatigue is a problem for advanced lung cancer patients and that QOL is impac ted. In an effort to better support and treat these patients, nurses should be assessing for the presence of fatigue and incorporating possible interventions in to nursing plans of care. Also, timely assessment of fatigue and subsequent interve ntion may assist patients in complying with treatment plans and lessen the incid ence of cessation of therapy due to intolerable toxicity in the form of fatigue. Provider assessment of fatigue was inconsistently and poorly documented in this study. In order to develop interventions t o assist advanced lung cancer patients with fatigue and impact QOL, nurses must a ssess for the presence of the symptom first. Barriers to assessment of fatig ue must be addressed and
38 scales that assist in more consistent assessment an d documentation of fatigue must be developed. Conclusions No statistically significant gender differences we re noted in the levels, severity, frequency or interference of fatigue in t he sample utilized in this study. Also, no statistically significant gender differenc es were noted in quality of life measures. Although there were some trends toward d ifferences in men and women with advanced lung cancer, no significant dif ferences were found. A larger sample may reveal a statistical difference w hich would confer the need to be aware of this difference when applying intervent ions to address fatigue. As fatigue has been shown to be a prevalent and distre ssing symptom in advanced lung cancer patients, it is important that as many facets of this issue are explored and documented by practitioners. For the establish ed interventions to assist in addressing fatigue and the many implications its pr esence has and to generally better serve these patients, assessment and subsequ ent documentation of fatigue levels must occur. Recommendations for future research Since the data from this study revealed that there was no difference in reported fatigue levels and quality of life levels between men and women, future studies should be conducted with larger sample size s to determine if there exists a statistical significance. Future studies should also seek to accrue a more racially diverse sample. Expanding the exploration of practitioner assessment of fatigue is imperative and should occur in multiple settings to truly establish
39 pattern. Further studies as to the actual and perc eived barriers to fatigue assessment and documentation by practitioners are i mperative.
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44Appendix A: Chart Audit Form Patient Screened for Presence and Severity of Fatigue? Method or Tool Utilized to Screen? Subject Number Date of Visit Physician Nurse 4 point verbal rating scale 5 point verbal rating scale 11 point numeric scale 4 point numeric scale 10cm visual analogue scale
45Appendix B: Medical Chart Review Form ID __ __ __ GENDER 0 Male 1 Female HEIGHT __ __ __ inches WEIGHT Pre-chemo weight: __ __ __ lbs. GROUP 1 UCO 2 SM 3 EX 4 SMEX DXDATE Date of initial diagnosis for cancer (physician ap proval date): __ __ / __ __ / __ __ __ __ (mm/dd/yy) RCDATE Date of diagnosis of cancer recurrence requiring cu rrent chemo: __ __ / __ __ / __ __ __ __ (mm/dd/yy) CATYPE Cancer type __ __ 1. Adrenal 16. Liver 2. Bladder 17. Lung 31. Sarcoma, not osteosarcoma 32. Squamous Cell 3. Bone (e.g., osteosarcoma) 33. Testicular 4. Breast 18. Lymphoma (Hodgkins, NHL, Mycosis Fungoides) 34. Thyroid 5. Brain 19. Melanoma 6. Carcinoid (GI) 20. Merkle Cell 35. Unknown Primary 7. Cervical 21. Mesothelioma 36. Uterine 8. Colon 22. Multiple Myeloma 37. Vaginal/Vulvar 9. Endometrial 23. Nasal & Sinus 88. Other: 10. Esophageal 24. Pharyngeal 11. Gastric (Stomach) 25. Neuroblastoma 12. Kidney 26. Ovarian 13. Layrnx 27. Pancreatic 28. Prostate 14. Leukemia (ALL, AML, CLL, CML) 29. Rectal/Anal 15. Lip & Oral cavity 30. Salivary CATYPE2 Does patient have a second cancer diagnosis? If yes, enter code from list: __ __ If no, leave blank. STAGE Stage at start of chemo: ___ 1 Stage I (Check one) ___ 2 Stage II ___ 3 Stage III ___ 4 Stage IV ___ 5 Limited Stage SCLC ___ 6 Extensive Stage SCLC
46Appendix B: (Continued ) ECOG0 Pre-Chemo ECOG Performance Status (check one): ___ 0 Fully active, able to carry on all pre-disease perf ormance without restriction ___ 1 Restricted in physically strenuous activity but amb ulatory and able to carry out work of a light or sedentary nature, e.g., light housework, o ffice work ___ 2 Ambulatory and capable of all selfcare but unable to carry out any work activities. Up and about more than 50% of waking hours ___ 3 Capable of only limited selfcare, confined to bed or chair more than 50% of waking hours ___ 4 Completely disabled. Cannot carry on any selfcare Totally confined to bed or chair Surgery SURG1D Most recent surgery date: __ __ / __ __ / __ __ __ __ (mm/dd/yy) SURG2D Previous surgery date: __ __ / __ __ / __ __ __ __ (mm/dd/yy) SURG3D Previous surgery date: __ __ / __ __ / __ __ __ __ (mm/dd/yy) Radiation Therapy XRTC XRT while on study : No 0 Yes 1 XRTCTX Number of XRT treatments while on study: __ __ XRTCDS Total dose of XRT while on study: __ __ __ __ XRTCSD Date of first Tx on study: __ __ / __ __ / __ __ __ __ (mm/dd/yy) XRTCED Date of last Tx on study: __ __ / __ __ / __ __ __ __ (mm/dd/yy) XRTP1 XRT prior to current chemo (most recent previous co urse): No 0 Yes 1 XRTP1TX Number of treatments during this course: __ __ XRTP1DS Total dose of XRT during this course: __ __ __ __ XRTP1SD Tx Start Date: __ __ / __ __ / __ __ __ __ (mm /dd/yy) XRTP1ED Tx End Date: __ __ / __ __ / __ __ __ __ (mm/d d/yy) XRTP2 XRT prior to current chemo (course before most rece nt previous course): No 0 Yes 1 XRTP2TX Number of treatments during this course: __ __ XRTP2DS Total dose of XRT during this course: __ __ __ __ XRTP2SD Tx Start Date: __ __ / __ __ / __ __ __ __ (mm/ dd/yy) XRTP2ED Tx End Date: __ __ / __ __ / __ __ __ __ (mm/d d/yy)
47Appendix B: (Continued) Concurrent Hormone Treatment HORTX1 Hormone treatment while on study : No 0 Yes 1 HORTXTY1 Type of hormone treatment: ___ 0 None ___ 1 Tamoxifen (Nolvadex) ___ 2 Megestrol (Megase) ___ 3 Leuprolide (Lupron) ___ 4 Gosarelin (Zoladex) ___ 5 Medroxyprogesterone (Provera) ___ 6 Triptorelin (Trelstar) ___ 7 Anastrozole (Armidex) ___ 8 Femara (Letrozole) HORSD1 Date of first Tx while on study: __ __ / __ __ / __ __ __ __ (mm/dd/yy) HORED1 Date of last Tx while on study: __ __ / __ __ / __ __ __ __ (mm/dd/yy) HORTX2 Hormone treatment while on study : No 0 Yes 1 Concurrent Biological Treatment BIOTX Biological treatment while on study : No 0 Yes 1 BIOTXTY Type of biological treatment: ___ 0 None ___ 1 Herceptin (Trastuzumab) ___ 2 BCG (Bacillus Calmete-Gurin) BIOSD Date of first Tx while on study: __ __ / __ __ / __ __ __ __ (mm/dd/yy) BIOED Date of last Tx while on study: __ __ / __ __ / __ __ __ __ (mm/dd/yy) Previous Chemotherapy PRVCHM Did patient receive chemo prior to the current chem o? No 0 Yes 1 PRVCHMX How many prior courses of chemo did patient receive ? __ __ (a course refers to a uniform prescription of chemo therapeutic drugs administered over a series of cycles, usually 21 day cycles) CHM1 Chemo prior to current chemo (most recent previous course): No 0 Yes 1
48Appendix C: Demographic Form GBI 1. Today's date: / / (MM/DD/YYYY) 2. Birth date: / / (MM/DD/YYYY) 3a. Ethnic group (check one): Hispanic/Spanish/Latino Not Hispanic/Spanish/Latino 3b. Racial Background (check one): American Indian or Alaskan Native Asian Black or African American More than one race (specify): Native Hawaiian/Pacific Islander White 4. Marital status (check one): Never married Currently married Separated Divorced Widowed 5a. Current living arrangement (check one box): Live alone Live with spouse/partner Live with spouse/partner and children Live with children (no spouse/partner) Live with roommate who is not partner Live with parents Other (specify): 5b. Number of children living at home (enter 0 if none) : 6. How long in current living arrangement (check one): Less than 1 month One to 6 months Seven months to less than 2 years Two to 5 years More than 5 years
49Appendix C: (Continued) 7. Level of school completed (check one): Less than 7th grade Junior High School (7th, 8th, & 9th grade) Partial High School (10th or 11th grade) High School graduate Partial college or specialized training College or university graduate Graduate professional training (graduate degree) 8. Current employment situation (check the one box tha t applies the most): A. WORKING Full time at job Part time at job B. ON LEAVE On leave with pay On leave without pay C. NOT EMPLOYED Disabled Seeking work Retired Homemaker Student 9. Which category best describes your usual occupation ? If you are not currently employed, which category best describes your LAST j ob? (check one): Professional (e.g., teachers/professors, nurses, la wyers, physicians, & engineers) Manager/Administrator (e.g., sales managers) Clerical (e.g., secretaries, clerks, or mail carrie rs) Sales (e.g., sales persons, agents, or brokers) Service (e.g., police, cooks, waiters, or hairdress ers) Skilled Crafts, Repairer (e.g., carpenters) Equipment or Vehicle Operator (e.g., truck drivers) Laborer (e.g., maintenance or factory workers) Farmer (e.g., owners, managers, operators, or tenan ts) Member of the military Homemaker (with no job outside the home) Other (please describe)
50Appendix C: (Continued) 10. Which category best describes your spouse's usual o ccupation? If your spouse is not currently employed, which category best describes h is/her LAST job? (check one): Do not have a spouse Professional (e.g., teachers/professors, nurses, la wyers, physicians, & engineers) Manager/Administrator (e.g., sales managers) Clerical (e.g., secretaries, clerks, or mail carrie rs) Sales (e.g., sales persons, agents, or brokers) Service (e.g., police, cooks, waiters, or hairdress ers) Skilled Crafts, Repairer (e.g., carpenters) Equipment or Vehicle Operator (e.g., truck drivers) Laborer (e.g., maintenance or factory workers) Farmer (e.g., owners, managers, operators, or tenan ts) Member of the military Homemaker (with no job outside the home) Other (please describe) 11. What is your approximate annual gross income? (check one) (Remember all information you provide will remain c ompletely confidential) Less than $10,000 $10,000 $19,999 $20,000 $39,999 $40,000 $59,999 $60,000 $100,000 Greater than $100,000 Prefer not to answer 12. Approximate annual gross income for your household : (check one box) (Remember all information you provide will remain c ompletely confidential) Less than $10,000 $10,000 $19,999 $20,000 $39,999 $40,000 $59,999 $60,000 $100,000 Greater than $100,000 Prefer not to answer
51Appendix D: FSI Questionnaire FSI For each of the following, check one box next to th e 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 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 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 h ousework) : 0 1 2 3 4 5 6 7 8 9 10 No Extreme Interference interference
52Appendix D: (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 the No co nsistent daily fatigued the morning afternoon evening pattern of f atigue
53Appendix E: SF-36 1. In general, would you say your health is Excellent Very good Good Fair Poor 2. Compared to one week ago, how would you rate your h ealth in general now? Much better now than one week ago............. Somewhat better now than one week ago.... About the same..................................... .......... Somewhat worse now than one week ago..... Much worse now than one week 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? Yes, limited Yes, limited No, not a lot a little 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.............................................. ...... j. Bathing or dressing yourself.................... ................. 4. During the past week have you had any of the following problems with y our work or other regular dailyactivities as a result of your physical health? 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)................. .......................................
54Appendix E: (Continued) 5. During the past week have you had any of the following problems with y our work or other regular daily activities as a result of any emotional problems (such as feeling depressed or anxious)? 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 week to what extent has your physical health or emotio nal problems interfered with your normal social activities with family, friends, neighbors, or groups? Not at all........................ Slightly........................... Moderately..................... Quite a bit...................... Extremely....................... 7. How much bodily pain have you had during the past week? None..................... Very mild.............. Mild..................... Moderate............... Severe................... Very severe............. 8. During the past week how much did pain interfere with your normal work (including both work outside the home and housework)? Not at all........................ A little bit........................ Moderately..................... Quite a bit...................... Extremely.......................
55Appendix E: (Continued) 9. These questions are about how you feel and how thin gs have been with you during the past week For each question, please give the one answer tha t comes closest to the way you have been feeling. All of Most of A good Some of A li ttle of None the time the time bit of the the time th e time of the time time How much of the time during the past week: a. Did you feel full of pep?............. b. Have you been a 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?....................... 10. During the past week how much of the time has your physical health or emotional problems interfered with your social activities (like visiti ng with friends, relatives, etc.)? All of the time............... Most of the time........... Some of the time.......... A little of the time....... None of the time............ 11. Please choose the answer that best describes how TRUE or FALSE each of the following statements is for you. Definitely Mostly Not Mostly Def initely True True Sure False 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...................
56 Appendix E: (Continued) 12. How much nausea have you had during the past week ? (Check one) None..................... Very mild.............. Mild..................... Moderate............... Severe................... Very severe.......... 13. During the past week how much did nausea 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...............