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Abstract
Grant Number: 5R21AT002531-03 Project Title: Polarity Therapy for Cancer-Related Fatigue
PI Information: Name Title MUSTIAN, KAREN M. karen_mustian@urmc.rochester.edu ASSISTANT PROFESSOR Abstract: DESCRIPTION (provided by applicant): Cancer-related fatigue (CRF) is the most frequently reported side effect of cancer and its treatment. Our data and the literature suggest that 60 - 96% of cancer patients experience CRF at some point during their course of cancer treatment, and that 77% of breast cancer patients report fatigue during radiation treatment. CRF has a profound effect on patients' health-related quality of life and activities of daily living, including increased sleep disturbance, difficulties with work-related activities, muscle weakness, and reduction in leisure activity. An effective treatment for CRF would benefit a large number of cancer patients. Preliminary data gathered by our research team suggest that Polarity Therapy (PT) is an efficacious, non-invasive intervention for alleviating CRF. Our investigation of 15 women with CRF receiving radiation therapy for breast cancer showed a statistically significant (p < .05) reduction in fatigue in women who received a single PT treatment compared with women who received standard care alone. Improvement in fatigue was reported by 8 of 10 patients receiving PT, but only 1 of 5 patients receiving standard care alone. The current application is for a pilot study to extend these preliminary findings by providing additional data on the efficacy of PT for reducing CRF, improving health-related quality of life, and improving quality of sleep in patients receiving radiation therapy for breast cancer. Additionally, this pilot study is designed to refine procedures and methods, provide a sample-size estimate, and aid in the a priori design of mediator and moderator analyses for a follow-up study in a planned R01 submission. The proposed study is a 3-arm randomized clinical trial with 60 patients undergoing radiation therapy for breast cancer who are experiencing fatigue. Arm 1: Patients (non-intervention control group) will receive standard clinical care. Arm 2: Patients (active control group) will receive standard clinical care plus 3 Swedish style massages to control for touch and personal attention. Arm 3: Patients will receive standard clinical care plus 3 PT treatments. Patients will be studied for a 26-day period encompassing daily radiation treatments. Fatigue, health-related quality of life, and quality of sleep will be determined at baseline and at three subsequent post-intervention assessments. In addition to a sleep/fatigue diary, actigraphy will be used during the entire 26-day study period to provide objective measures of sleep and fatigue. Anticipated results could have clinical, methodological, and theoretical application in the treatment and study of CRF, a symptom affecting most cancer patients during radiation therapy.
Public Health Relevance:
This Public Health Relevance is not available.Thesaurus Terms:
alternative medicine, cancer complication, fatigue, neoplasm /cancer palliative treatment
breast neoplasm, clinical trial, massage therapy, quality of life, radiation therapy, sleep, therapy adverse effect, therapy design /development, women's health
actigraphy, clinical research, female, human subject, human therapy evaluation, patient oriented research, personal log /diary
Institution: UNIVERSITY OF ROCHESTER 517 Hylan Bldg., Box 270140 ROCHESTER, NY 14627 Fiscal Year: 2007 Department: CANCER CENTER Project Start: 30-SEP-2005 Project End: 31-AUG-2009 ICD: NATIONAL CENTER FOR COMPLEMENTARY & ALTERNATIVE MEDICINE IRG: ZAT1