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The correlation between depression and neuropathy limitations in chemotherapy patients
h [electronic resource] /
by Melissa Thebeau.
[Tampa, Fla] :
b University of South Florida,
Title from PDF of title page.
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Thesis (MS)--University of South Florida, 2010.
Includes bibliographical references.
Text (Electronic thesis) in PDF format.
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ABSTRACT: This study examined the association between neuropathy limitations and depression in chemotherapy patients currently on treatment with a taxane-based, platinum-based or plant alkaloid chemotherapy drug. The Overall Neuropathy Limitations Scale (ONLS) and the Beck Depression Inventory-Short Form (BDI-SF) were used to assess neuropathy limitations and depression in 24 chemotherapy patients with reported symptoms of peripheral neuropathy. Average age of patients was 65 years, 66.6% were female, and average number of chemotherapy cycles completed was 5.6. Of the 24 patients, 37.5% of patients were on a single agent taxane-based drug, 37.5% of patients were on a taxane-based drug with a platinum based drug, 16.6% of patients were on a plant alkaloid, and 8.3% were on a combination of a taxane-based and another non-neurotoxic chemotherapy drug. The scores on both the BDI-SF and ONLS were very low. The mean score on the BDI-SF was 4.1 with a standard deviation of 2.7. The mean score on the ONLS was 2.2 with a standard deviation of 1.5. The study showed a non-significant relationship between neuropathy limitations and depression in chemotherapy patients. These findings show no association between neuropathy limitations and depression. Although all of these patients had symptoms of peripheral neuropathy, they were not severe enough to interfere with daily activities. The lack of relationship was not unexpected given the low scores on both the BDI-SF and ONLS. Future research should re-evaluate this relationship with a larger, more diverse sample.
Advisor: Susan C. McMillan, Ph.D., ARNP
Chemotherapy Induced Peripheral Neuropathy
t USF Electronic Theses and Dissertations.
The Correlation Between Neuropathy Limitations and Depression in Chemotherapy Patients By Melissa Thebeau 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: Susan C. McMillan, Ph.D., A.R.N.P Cindy Tofthagen, Ph.D., A.R.N.P. Laurie Stark, R.N., M.S. Date of Approval: June 23, 2010 Keywords: Chemotherapy Induced Peripheral Neuropat hy, Cancer Oncology, Nursing, Functional Status Copyright 2010, Melissa Thebeau
i Table of Contents List of Tables iii Abstract iv Chapter One Introduction 1 Problem Statement 2 Research Questions 3 Definition of Terms 3 Significance of the Study 4 Chapter Two Review of Literature 5 Peripheral Neuropathy and Cancer 5 Peripheral Neuropathy and Diabetes 6 Depression and Cancer 7 Peripheral Neuropathy and Depression 8 Summary 8 Chapter Three Methods Sample 10 Instrumentation 10 Beck Depression Inventory-Short Form 10 Overall Neuropathy Limitations Scale 11 Procedures 11 Data Analysis 12 Chapter Four Results, Discussion and Conclusion 13 Results 13 Beck Depression Inventory-Short Form 13 Overall Neuropathy Limitations Scale 13 Discussion 14 Beck Depression Inventory-Short Form 14 Overall Neuropathy Limitations Scale 15 Relationship Between Peripheral Neuropathy and De pression 15 Conclusion 16 References 17
iiAppendices 19 Appendix A: Beck Depression Inventory-Short Form 20 Appendix B: Overall Neuropathy Limitations Scale 21 Appendix C: Letter of Approval Florida Cancer Ins titute-New Hope 23 Appendix D: Letter of Approval USF Institutional Review Board 24 Appendix E: Informed Consent 25
iii List of Tables Table 1 Frequencies and Percentages of Descriptive Demographic Data 14 Table 2 Means, Standard Deviations, and Ranges for Depression and Neuropathy Scores 14
iv The Correlation Between Neuropathy Limitations and Depression in Chemotherapy Patients Melissa Thebeau ABSTRACT This study examined the association between neurop athy limitations and depression in chemotherapy patients currently on tr eatment with a taxane-based, platinum-based or plant alkaloid chemotherapy drug. The Overall Neuropathy Limitations Scale (ONLS) and the Beck Depression Inventory-Short Form (BDI-SF) were used to assess n europathy limitations and depression in 24 chemotherapy patients with reporte d symptoms of peripheral neuropathy. Average age of patients was 65 years, 66.6% were female, and average number of chemotherapy cycles completed was 5.6. O f the 24 patients, 37.5% of patients were on a single agent taxane-based drug, 37.5% of patients were on a taxane-based drug with a platinum based drug, 16.6% of patients were on a plant alkaloid, and 8.3% were on a combination of a taxane-based and another non-neu rotoxic chemotherapy drug. The scores on both the BDI-SF and ONLS were very lo w. The mean score on the BDI-SF was 4.1 with a standard deviation of 2.7. T he mean score on the ONLS was 2.2 with a standard deviation of 1.5. The study showed a non-significant relationship between neuropathy limitations and depression in ch emotherapy patients. These findings show no association between neuropa thy limitations and depression. Although all of these patients had sym ptoms of peripheral neuropathy, they were not severe enough to interfere with daily acti vities. The lack of relationship was not
v unexpected given the low scores on both the BDI-SF and ONLS. Future research should re-evaluate this relationship with a larger, more d iverse sample.
1 Chapter One Introduction Cancer accounts for nearly a quarter of deaths in t he United States each year, only outranked by heart disease. In 2009, there were an estimated 1,479,350 new cancer cases diagnosed (American Cancer Society, 2010). Of thes e patients, nearly half of them will receive chemotherapy treatment. Scientists have ma de a great deal of progress in developing treatments to manage the potential side effects of chemotherapy. Common chemotherapy side effects include infections, nause a and vomiting, hair loss, constipation, diarrhea, fatigue, and nerve damage. Of particular concern, these side effects may lead to problems of adherence to treatm ent and diminished quality of life (Gralla, Houlihan, & Messner, 2010). One of the side effects of chemotherapy, nervous sy stem damage, can present with a unique set of complications. Peripheral neu ropathy (PN) is a complication that patients experience when the chemotherapy drugs dam age their nerves. It is often characterized by pain, numbness, and tingling in th e hands and feet (Gralla, Houlihan, & Messner, 2010). Types of chemotherapy treatments t hat commonly cause PN include: taxanes like paclitaxel, docetaxel and abraxane; pl atinum drugs such as cisplatin and oxaliplatin; and plant alkaloids such as vincristin e, vinorelbine and vinblastine (American Cancer Society, 2010). PN may present as pain, nu mbness and tingling in the extremities. Ototoxicity, changes in vision, blood pressure, and gastrointestinal function
2 infrequently occur (Bakitas, 2007). These conditio ns may cause limitations in a patientÂ’s daily activities. Although effective chemotherapy treatments have bee n discovered, PN continues to be a common complication affecting nerves includ ing the sensory, motor, and autonomic systems (Stitham, 2008). The limitations that PN cause have the potential to add an increased level of stress and possible anxie ty to cancer patients who already are managing many new issues. Individuals who are expe riencing PN may be unable to perform many tasks independently, and may be at a h igher risk for depression. There are several factors that put a cancer patient at risk for depression. Some of these risk factors include living with the disease, medications that are prescribed to manage the cancer and side effects, poor support sy stems, and unrelieved symptoms such as pain (Hamilton, 2005). A paucity of research h as been conducted to determine the effect of peripheral neuropathy symptoms on the men tal health of those diagnosed with cancer. Problem Statement Currently, there is little or no research focusing on the relationship between limitations of chemotherapy induced peripheral neur opathy and depressive symptoms. The purpose of this study was to determine whether there is a relationship between the physical limitations of chemotherapy induced periph eral neuropathy experienced by patients with cancer and depressive symptoms. This study explored whether patients who are curren tly under treatment with a taxane-based, platinum-based or plant alkaloid chem otherapy and who are suffering from
3 limitations of chemotherapy induced peripheral neur opathy have an increased risk of depressive symptoms. Research Questions The following questions guided this study: 1. What is the level of depression symptomatology experienced by cancer patients receiving neurotoxic chemotherapy? 2. What is the level of neuropathy limitations in patients receiving neurotoxic chemotherapy? 3. What is the relationship between depressive sym ptoms and the level of neuropathy limitations in patients receiving neurotoxic chemot herapy? Definition of Terms The following terms are defined for purposes of thi s study: Peripheral Neuropathy Â– Occurs when nerves are damaged or destroyed and cannot send messages from the brain and spinal cord to the musc les, skin, and other parts of the body. Symptoms often include: a sensation of wearing an invisible glove or sock, burning sensation or freezing pain, sharp jabbing or electr ic-like pain, extreme sensitivity to touch, difficulty sleeping because of feet and leg pain, loss of balance and coordination, muscle weakness, difficulty walking or moving the a rms, and may include unusual sweating, and abnormalities in blood pressure or pu lse. (Miller, 2007) Neuropathy Limitations Â– Limitations from neuropathy are caused from damaged nerves in the sensory, motor and autonomic systems. These may cause sensation changes, an inability to determine joint position which causes lack of coordination, loss of dexterity, cramps, falling from legs buckling or tripping over toes. It may cause lack of dexterity,
4 such as being unable to button a shirt, and lack of muscle control. Heat or cold intolerance, blurred vision, feeling dizzy and/or f ainting, and feelings of incomplete bladder emptying. (Stitham, 2008) Depression Â– A mood disorder marked by loss of interest or pl easure in living. A feeling of sadness. (Davis, 2001) Depressive Symptoms Â– Symptoms of depression may include persistent sa dness, hopelessness, loss of energy, irritability, excessi ve sleep or decreased interest in daily activities. (Davis, 2001) Significance of the Study This study investigates a possible relationship bet ween limitations from chemotherapy induced peripheral neuropathy and depr ession. PN may cause pain and alter patientsÂ’ activities of daily living. As pat ientsÂ’ lose independence with daily activities they may become depressed. Symptoms of PN may limit the ability for an individual to remain independent in activities of d aily living. The more severe the symptoms of PN become, the more depressed a person may feel. These feelings of depression may lead to non-adherence with treatment or diminished quality of life. An analysis of previous studies found that depressed p atients are three times less likely to comply with treatments than patients who are not de pressed (McManamy, 2009).
5 Chapter Two Review of Literature This chapter presents the review of literature rele vant to this study. The review of literature describes the symptoms of patients with peripheral neuropathy (PN) and the effect PN has on quality of life. This reviews empi ric evidence of the effects of chemotherapy on a patientÂ’s emotional status, and h aving PN and depressive symptoms. Through research, nurses may better understand the relationship between having symptoms of PN and depressive symptoms for patients receiving chemotherapy. Peripheral Neuropathy and Cancer Little is known about the development of peripheral neuropathy. Depending on the chemotherapy, PN side effects can range from a sensory and painful neuropathy to a mixed sensory-motor neuropathy with or without auto nomic nervous system involvement (Sioka & Kyritsis, 2008). These investigators revi ewed the neurotoxicity induced by some of the most common chemotherapeutic agents. T he platinum-based drugs were found to cause pure sensory neuropathies, the taxan e-based drugs caused a mixed sensory and motor neuropathy, and the plant alkaloids cause d both mixed sensory-motor and autonomic neuropathies. Bakitas (2007) interviewed 28 patients undergoing a variety of different chemotherapy regimens in order to describe the expe rience and the influence of PN symptoms on everyday life. Patients reported taxan e-based chemotherapy induced peripheral neuropathy as one of the most distressin g treatment-related symptoms and a
6 major cause of alterations in function and quality of life. Some participants described the pain as annoying, distracting, and unpleasant. Whe n asked about functional ability, patients rated the discomfort as a three or four ou t of ten. When asked how much the PN complicated everyday activities, patients rated it as a seven or eight out of ten. PN interrupts dressing, putting on jewelry, balance, a nd driving (Bakitis, 2007). Emotional distress was attributed to having to deal with phys ical symptoms of PN, as well as functional and social limitations. Peripheral Neuropathy and Diabetes Diabetic peripheral neuropathy (DPN) is a common sy mptom experienced by those with advanced diabetes. Individuals diagnose d with diabetes are not included in this study; however, those suffering from PN may re port similar symptoms. In order to demonstrate the burden of PN, three studies were re viewed. Argoff, Cole, Fishbain, Irving and Mmed (2006) revi ewed the current knowledge about diabetic peripheral neuropathy pain (DPNP). They found that up to 50% of diabetic patients experienced some degree of PN. N early a third of those with type 1 diabetes and more than half of those with type 2 di abetes mellitus (DM) had at least one neuropathic symptom. Patients with type 2 DM were more likely to have paresthesia and/or burning pain. The most common presentation of DPNP is pain or tingling in the feet. Tolle, Xu, and Sadosky (2005) completed a study to determine the burden of DPNP. One-hundred and forty patients with DPNP com pleted a questionnaire that was focused on pain intensity and impact of functioning Of the patients who participated, 57% reported moderate pain and 25% reported severe pain. Overall, 91% of the patients
7 reported using prescription medication for their DP NP. Use of medications for anxiety, depression, or sleep disturbances were reported for nearly half of the patients. This study concluded that DPNP is associated with substa ntial patient burden resulting from interference with daily functioning. The final study (Hoffman, Sadosky, & Alvir, 2008) e xamined functional and health status impairments among patients with DPNP. The study was conducted in 19 countries and included 401 diabetic patients with D PNP. Patients reported DPNP to be more severe at night and stated that it frequently disrupts sleep. The study also showed that PN is associated with major life disturbances including more physician office visits, interference with daily activities such as ambulati ng and sleeping, and interference at work. Depression and Cancer Depression in cancer patients is not yet completely understood. It is not clear whether the depression contributes to the cancer, o r whether the stress of having cancer causes the depression. No matter how they happen, cancer and depression seem to cocoincide. The studies conducted in this area demon strate that the acceptance of an adjuvant chemotherapy regimen relies heavily on whe ther or not the patient is depressed (Colleoni, et al., 2000). Patients who undergo in itial diagnosis of cancer may become depressed, which can interfere with treatment decis ions and adherence to therapy. These patients may have poorer outcomes because symptoms of depression include fatigue, loss of appetite and insomnia. All of these symptoms ma ke it difficult to continue treatment. Results of the study suggested that depression repr esents a crucial factor for initial acceptance of adjuvant chemotherapy, and that by tr eating the patientÂ’s depression,
8 practitioners may improve the patientsÂ’ overall pro gnosis. One study (Watson et al., 1999) of 395 women with breast cancer revealed that at five years there was a significantly increased risk of death in women with a high score on the depression scale. There was also a correlation for these women betwee n risk of relapse or death in women with high scores on the helplessness and hopelessne ss scale. Peripheral Neuropathy and Depression Pain severity from PN is associated with depression A study reported in 2005 (Gore et al.) evaluated pain severity, pain-related interference with function, sleep impairment, symptom levels of anxiety and depressio n, and quality of life among patients with painful DPN. Results were based on patient se lf-reports. With PN, chronic pain, sleep disturbance, and affective disorders often oc cur simultaneously and often do not decline over time. The primary pain measure in thi s study looked at the severity of pain on a 0 to 10 scale, and its interference with seven factors including general activity, mood, walking ability, normal work, relations with others, and enjoyment of life. Results showed that increases in pain resulted in increased difficulty in all seven areas. The Hospital Anxiety and Depression Scale (HADS) measur ement tool was used to assess anxiety and depression in the patients. More than half of the patients indicated that they were moderately or severely anxious or depressed. Summary The review of literature discusses empiric evidence supporting the relationships between peripheral neuropathy and depression. When patients are depressed, judgment may be impaired. Colleoni et al. (2000) showed tha t depression is a crucial factor for initial acceptance of treatment. Sioka et al. (200 8) demonstrated that the most common
9 chemotherapy treatments, including taxane-based, pl atinum-based and plant alkaloid therapies, are all capable of causing neurotoxicity Symptoms of PN may contribute to depressive symptoms (Bakitas, 2007). This is also confirmed by Tolle et al. (2005), who found that nearly half of patients who were sufferi ng from diabetic peripheral neuropathy were also taking medications for anxiety, depressio n, or sleep disturbances.
10 Chapter Three Methods This chapter presents the study methods. The chapt er includes descriptions of the sample, instrumentation, procedures, and data analy sis for the study. Sample A sample of 30 adult patients receiving chemotherap y treatment with a taxanebased, platinum-based or plant alkaloid therapy was sought. Patients who had reported numbness or tingling in their hands and/or feet wer e included in the study. Patients who were treated for depression prior to chemotherapy w ere excluded from the study. Patients with pre-existing PN from diabetes were ex cluded from the study. Instrumentation Beck Depression Inventory-Short Form (BDI-SF) The Beck Depression Inventory-Short Form (BDI-SF) w as developed in 2003 (Appendix A). It assesses the same symptoms as the original Beck Depression Form, with a shorter, less burdensome format for the pati ents. Rather than the original 21 questions, the BDI-SF presents nine questions with four possible answers each. Total scores range from zero to 36 with scores as follows : 0 to 10 is not depressed, 12 to 19 is depressed and greater than 20 is very depressed (Fu rlanetto, Mendlowicz, & Bueno, 2005). Individual questions of the BDI-SF assess mood, pes simism, sense of failure, selfdissatisfaction, guilt, punishment, self-dislike, s elf-accusation, suicidal ideas, crying, irritability, social withdrawal, body image, work d ifficulties, insomnia, fatigue, appetite,
11 weight loss, bodily preoccupation, and loss of libi do. The BDI-SF was shown to be a valid instrument for the identification of depressi on, with a sensitivity of 100% and specificity of 83.1% (Furlanetto et al., 2005). Overall Neuropathy Limitations Scale (ONLS) The ONLS is a scale that is used to assess limitati ons and disability caused by peripheral neuropathy (Appendix B). The ONLS is co mposed of two sections that total 12 questions. Items 1 to 6 assess neuropathy sympt oms in the hands or arms, while items 7 to 12 assess the same symptoms in the legs and fe et. Each question has three possible responses that range from; not affected, affected b ut not prevented, to prevented. The ONLS is calculated by adding the arm scale total an d the leg scale total. The final score can range from 0 (no disability) to 12 (maximum dis ability). Acceptable responsiveness was shown with the ONLS (Graham, & Hughes, 2006). Procedures Patients from one outpatient facility were included in this study. After permission was obtained from the facility to include patients in the study (Appendix C), the proposal and permission letter were submitted to the USF Ins titutional Review Board for the Protection of Human Subjects (Appendix D). Followi ng approval, clinic staff identified patients who reported numbness and tingling in thei r hands and/or feet. The study was explained to the patients by the primary investigat or and questions answered. The patients signed the informed consent (Appendix E), a copy of the informed consent was given to the patient, and he or she was asked to co mplete the study forms. The BDI-SF was completed by the patient and the ONLS was admin istered by the primary investigator. The primary investigator asked the q uestions on the ONLS and the patient
12 answered based on self-perception. Family members were present during the interview with some of the study participants. Data Analysis The level of depression symptomatology and the limi tations from peripheral neuropathy symptoms experienced by cancer patients were statistically analyzed using means and standard deviations. The relationship be tween depressive symptoms and limitations of peripheral neuropathy in chemotherap y patients were analyzed using Pearson correlation.
13 Chapter Four Results, Discussion, and Conclusions This chapter presents the data collection process a nd the results. The significance of the study, the results, and the relevance to nur sing are also discussed. Results The sample included 24 adult participants. Twenty-e ight patients were approached and four were excluded because of diabetes or diabe tic neuropathy. Age range was 45-87 with the average participant age of 65 years. One participant was 100 years old. Of the 24 patients, 37.5% of them were on a single agent t axane-based drug, 37.5% of patients were on a combination of a taxane-based drug with a platinum based drug, 16.6% of patients were on a plant alkaloid, and 8.3% were on a combination of a taxane-based and a non-neurotoxic chemotherapy drug. All patients h ad some symptoms of PN. The sample was made up of 66.6% females, and 92% were C aucasian. (Table 1) Beck Depression Inventory-Short Form (BDI-SF) The BDI-SF is a patient self-report scale. Possibl e scores range from 0 to 36 where 0 to 10 is not depressed, 11 to 19 is depress ed and greater than or equal to 20 is very depressed. In this study the mean score was 4 .125. The lowest score reported was one and the highest score was 12. There was only on e reported score of 12. (Table 2) Overall Neuropathy Limitations Scale (ONLS) The ONLS scale is calculated by adding the arm scal e total and the leg scale total. The final score can range from 0 (no disability) to 12 (maximum disability). In this
14 sample of 24 adults, the mean score was 2.2. The l owest score reported was zero and the highest score was five. (Table 2) Table 1. Frequencies and Percentages of Descriptiv e Demographic Data Descriptive Demographic Frequency Percentage Ethnicity Caucasian-Non-Hispanic 22 92% Caucasian-Hispanic 2 8% Gender Male 8 33.3% Female 16 66.6% Table 2. Means, Standard Deviations, and Ranges fo r Depression and Neuropathy Scores Variable N Possible Range Sample Range Mean Standard Deviation Beck Depression Inventory 24 0-36 1-12 4.1 2.7 Overall Neuropathy Limitations Scale 24 0-12 0-5 2.2 1.5 Discussion Beck Depression Inventory-Short Form (BDI-SF) The BDI-SF is short, and easy to read for patients. None of the participants voiced confusion over any of the questions. On ave rage it took patients three minutes to
15 complete the short form. The scores overall were l ow. With a possible range of 0 to 36 the mean score was 4.1. These results are not cons istent with earlier studies reviewed. Tolle et al. (2005) found that patients with periph eral neuropathy were so depressed they required medications for anxiety, depression and sl eep disturbances. There are some limitations of the study. The small sample size, due to time limitations, may have excluded some patients with w orse symptoms. Also, patients completing the form in the presence of loved ones m ay not have been truthful or honest with their answers. Some patients do not want thei r family members to know if they are having emotional difficulties. These limitations m ay have contributed to the low scores. Overall Neuropathy Limitations Scale (ONLS) The ONLS is a short survey. It was administered to the patient by the primary investigator. On average it took patients five min utes to complete the scale. With a possible range from 0 to 12 the mean score w as 2.2. Patients with minimal neuropathy symptoms were able to participate in the study, which may account for some of the low scores. Patients had received an averag e of 5.9 cycles of chemotherapy, which is a sufficient amount of time for neuropathy sympt oms to present. Scores might be higher if symptom severity were measured instead of interference with activity. Also, the ONLS was administered by asking the patient about i nterference with the various activities. Scores might have differed if the prim ary investigator were to observe the patient doing the activities instead of relying on self-report. Relationship Between Peripheral Neuropathy and Depr ession The patients in this study did not show a signific ant relationship between their neuropathy limitations and depression. Scores were low on both measures. This may
16 have contributed to the lack of correlation. These findings were not consistent with previous studies. Conclusions A study might be done in the future with a few chan ges. First, the sample size should be increased. This may be improved by colle cting data over a longer period of time. This would allow for a wider variety of pati ents with a wider array of physical and mental symptoms. And second, the search criteria s hould include only patients with a grade two or above PN. Potentially, these changes would increase scores and result in more significant results. It is important for nurses to understand the physic al and mental effects that chemotherapy can have on patients. Peripheral neu ropathy can manifest in many different ways and the limitations of ability to pe rform activities of daily living can be devastating. It makes sense that the loss of auton omy would cause some depressive symptoms. It is for this reason that patients need early detection of symptoms and supportive care throughout chemotherapy treatment.
17 References American Cancer Society (2010). Peripheral neuropa thy caused by chemotherapy. Retrieved May 28, 2010 via the World Wide Web: htt p://www.acsevents.org Argoff, C., Cole, B., Fishbain, D., Irving, G., & M med, M. (2006). Diabetic peripheral neuropathic pain: Clinical and quality-of-life iss ues. Mayo Clinic Proceedings, 81 (4), S3-S11. Bakitas, M. (2007). Background noise: The experie nce of chemotherapy-induced peripheral neuropathy. Nursing Research, 56 (5), 323-331. Beuken, M.H.J., Rijke, J.M., Kessels, A.G., Schoute n, H.C. Kleef, M., & Patijn, J. (2007). Prevalence of pain in patients with cancer: a systematic review of the past 40 years. Annals of Oncology, 18 (9), 1437-1449. Colleoni, M., Mandala, M., Peruzzotti, G., Robertso n, C., Bredart, A., & Goldhirsch, A. (2000). Depression and degree of acceptance of adju vant cytotoxic drugs. The Lancet, 356 (9238), 1326-1327. Davis, F.A. (2001). TaberÂ’s cyclopedic medical dictionary (19th ed.). Philadelphia: F.A. Davis Company. Furlanetto, L., Mendlowicz, M., & Bueno, J., 2005. The validity of the BeckDepression Inventory-Short Form as a screening and diagnostic instrument for moderate and severe depression in medical inpatient s Journal of Affective Disorders, 86( 1), 87-91. Gore, M., Brandenburg, N., Dukes, E., Hoffman, D., Tai, K.S., & Stacey, B. (2005). Pain severity in diabetic peripheral neuropathy is associated with patient functioning, symptom levels of anxiety and depressi on, and sleep. Journal of Pain and Symptom Management, 30 (4), 374-385. Graham, R.C., & Hughes, R.A.C. (2006). A modified peripheral neuropathy scale: The Overall Neuropathy Limitations Scale. Journal of Neurology, Neurosurgery & Psychiatry with Practical Neurology, 77(1), 973-976 Gralla, R., Houlihan, N., & Messner, C. (2010). Un derstanding and managing chemotherapy side effects. New York: CancerCare Grohl, J. (2008). Depression. Psych Central. Ret rieved May 27, 2010 via the World Wide Web: http://psychcentral.com/disorders/depres sion
18 Hoffman, D., Sadosky, A., & Alvir, J. (2008). Cros s-national burden of painful diabetic peripheral neuropathy in Asia, Latin Ameri ca, and the Middle East. Pain Practice, 9 (1), 35-42. McManamy, J. (2009). Depression and cancer. Retri eved March 24, 2009 via the World Wide Web: http://mcmanweb.com/article-43.htm Miller, J., (2007). About Peripheral Neuropathy. The University of Chicago. Retrieved January 11, 2010 via the World Wide Web: http://mikllercenter.uchicago.edu Sioka, C., Kyritsis, A. (2009). Central and periph eral nervous system toxicity of common chemotherapeutic agents. Cancer Chemotherapy Pharmacol, 63 761767. Stitham, S. (2008). Peripheral neuropathy. Retrie ved May 28, 2010 via the World Wide Web: http://www.nlm.nih.gov/medlineplus/ency/artic le/000593.html Tolle, T., Xu, X., & Sadosky, A. (2006). Painful d iabetic neuropathy: A crosssectional survey of health state impairment and tre atment patterns. Journal of Diabetes and its Complications, 20 (1), 26-33. Watson, M., Haviland, J.S., Greer, S., Davidson, J. Bliss, J.M. (1999). A psychological response on survival in breast cancer: A populatio n-based cohort study. Lancet, 354(9187), 1331-6
20 Appendix A: Beck Depression Inventory-Short Form
21 Appendix B: Overall Neuropathy Limitations Scale OVERALL NEUROPATHY LIMITATIONS SCALE (ONLS) Instructions: The examiner should question and obs erve the patient in order to determine the answers to the following questions. Note should be made of any ot her disorder other than peripheral neuropathy which limits function at the foot of the page. ARM SCALE Does the patient have any symptoms in their hands o r arms; e.g. Tingling, numbness or weakness? Yes No Is the patient affected in their ability to: Not a ffected Affected but not prevented Prevented Wash and brush their hair Turn a key in a lock Use a knife and fork together Do or undo buttons or zips Dress the upper part of their body excluding buttons or zips If all these functions are prevented can the patien t make purposeful movements with their hands or arm s? Yes No Arm Grade 0= Normal 1= Minor symptoms in one or both arms but not affec ting any of the functions listed 2= Disability in one or both arms affecting but not preventing any of the functions listed 3= Disability in one or both arms preventing at lea st one but not all functions listed 4= Disability in both arms preventing all functions listed but purposeful movement still possible 5= Disability in both arms preventing all purposefu l movements SCORE=_____ LEG SCALE Yes No N/A Does the patient have difficulty running or climbin g stairs? Does the patient have difficulty with walking? Does their gait look abnormal? How do they mobilize for about 10 meters (33 feet)? Without aid With one stick or crutch or holding to someoneÂ’s a rm With two sticks or crutches or one stick or Crutch holding onto someoneÂ’s arm or frame With a wheelchair
22 If they use a wheelchair, can they stand and walk 1 meter with the help of one person? If they cannot walk as above are they able to make some purposeful Movements of their legs; e.g. reposition legs in be d? Does the patient use ankle or foot braces? Leg Grade 0= Walking/climbing stairs/running not affected 1= Walking/climbing stairs/running is affected, but gait does not look abnormal 2= Walks independently but gait looks abnormal 3= Requires unilateral support to walk 10 meters (s tick, single crutch, one arm) 4= Requires bilateral support to walk 10 meters (st icks, crutches, crutch and arm, frame) 5= Requires wheelchair to travel 10 meters but able to stand and walk 1 meter with the help of one per son 6= Restricted to wheelchair, unable to stand and wa lk 1 meter with the help of one person, but able to make some purposeful leg movements 7= Restricted to wheelchair or bed most of the day, unable to make any purposeful movements of the leg s Overall Neuropathy Limitations Scale=arm scale (ran ge 0 to 5) + leg scale (range 0 to 7) Range 0 (no disability) to 12 (maximum disability) TOTAL SCORE=_____
23 Appendix C: Letter of Approval Florida Cancer Inst itute-New Hope
24 Appendix D: Letter of Approval USF Institutional R eview Board
25 Appendix E: Informed Consent Informed Consent to Participate in Research Information to Consider Before Taking Part in this Research Study IRB Study # Pro00000265 Researchers at the University of South Florida (USF ) study many topics. To do this, we need the help of people who agree to take part in a research study. This form tells you about this research study. We are asking you to take part in a research study that is called: The Correlation Between Neuropathy Limitations and Depression in Chemotherapy Patients. The person who is in charge of this research study is Melissa Thebeau, RN, OCN. This person is called the Principal Investigator. However, other research staff may be involved and c an act on behalf of the person in charge. The research will be done at Florida Cancer Institu te-New Hope in New Port Richey, Fl. Purpose of the study The purpose of this study is to: The purpose of this study is to find a correlation between chemotherapy-induced peripheral neuropathy and depression in chemotherapy patients. Peripheral Neuropathy is nerve damage in your arms and legs and can cause pain numbness and tingling in those body parts. The study is being conducted by a USF graduate nurs ing student. All data collection and analysis will be overseen by a USF instructor. Study Procedures If you take part in this study, you will be asked t o: 1) Sign this informed consent stating voluntary wil lingness to participate in the study. 2) Complete the two brief questionnaires: The Beck Depression Scale and the Overall Neuropathy Limitations Scale. 3) The questionnaires will be completed in the chem otherapy infusion room. 4) This one visit is all that is required for this study. No follow-up visits or phone calls will be made. 5) No audio or videotaping will be used. All forms are confidential and do not contain any personal demographic information. 6) If serious depression levels are found, patient may be referred to appropriate resources. Alternatives You have the alternative to choose not to participa te in this research study. Benefits The benefit of this study includes evaluation of yo ur depression status. If depression is found, refe rral to appropriate resources may be made. Risks or Discomfort Risks in this study include any personal discomfort during the interview used to complete the depressi on survey.
26 Compensation We will not pay you for the time you volunteer whil e being in this study. Conflict of Interest Statement There is no conflict of interest involving the prin cipal investigator in this study. Privacy and Confidentiality We must keep your study records private and confide ntial; however, certain people may need to see your study records. By law, anyone who looks at your records must keep them completely confidential. The only people who will be allowed to see these records are: The research team, including the Principal Investig ator, study coordinator, research nurses, and all other research staff Certain government and university people who need t o know more about the study. For example, individuals who provide oversi ght on this study may need to look at your records. This is done to make sure tha t we are doing the study in the right way. They also need to make sure that we are protecting your rights and your safety.) These include: o The University of South Florida Institutional Revie w Board (IRB) and the staff that work for the IRB. Other individuals who work for USF that provide other kinds of oversight may also need to l ook at your records. o The Department of Health and Human Services (DHHS). Confidentiality may be broken if there is suspicion of threat of harm to self or others. This information would be found during the completion of the Beck Depression Inventory. We may publish what we learn from this study. If w e do, we will not let anyone know your name. We will not publish anything else that would let people know who you are. Voluntary Participation / Withdrawal You should only take part in this study if you want to volunteer. You should not feel that there is any pressure to take part in the study, to please the investigator or the research staff. You are free to participate in this researc h or withdraw at any time. There will be no penalty or loss of benefits you are entitled to receive if you stop taking part in this study. New information about the study During the course of this study, we may find more i nformation that could be important to you. This includes information that, once learned, might caus e you to change your mind about being in the study. We will notify you as soon as possible if s uch information becomes available. Questions, concerns, or complaints If you have any questions, concerns or complaints a bout this study, call the Melissa Thebeau, RN, OCN, primary investigator at 727-505-8 393.
27 If you have questions about your rights as a partic ipant in this study, general questions, or have complaints, concerns or issues you want to dis cuss with someone outside the research, call the Division of Research Integrity a nd Compliance of the University of South Florida at (813) 974-9343. Consent to Take Part in this Research Study It is up to you to decide whether you want to take part in this study. If you want to take part, please sign the form, if the following statem ents are true. I freely give my consent to take part in this study I understand that by signing this form I am agreeing to take part in research. I hav e received a copy of this form to take with me. _____________________________________________ _____ _______ Signature of Person Taking Part in Study Date _____________________________________________ Printed Name of Person Taking Part in Study