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Project Number: 5R21CA098659-02 Contact PI / Project Leader: BALK, JUDITH L.
Abstract Text:
DESCRIPTION (provided by applicant): Cancer-related fatigue is a substantial problem for cancer patients and their caregivers. Little is known about the mechanisms underlying fatigue and even less about its management. Acupuncture has been suggested to improve cancer-related fatigue, but no randomized clinical trials have been conducted. We hypothesize that true acupuncture will reduce cancer-related fatigue in breast cancer patients receiving radiation therapy compared to sham acupuncture. In order to test this hypothesis, we propose the following specific aims: 1) Assess the acceptability of participation in a randomized, sham versus real acupuncture trial and measure adherence to a six-week treatment regimen. 2) Evaluate the impact of real versus sham acupuncture treatments on fatigue (FACIT-F), quality of life (SF-36), and cancer-related fatigue distress (CRFDS) at three points in time: three weeks, six weeks, and ten weeks, compared to pre-acupuncture/pre-radiation therapy baseline. 3) Investigate whether baseline levels of fatigue (higher versus lower) are associated with differential results from acupuncture treatments (more improved vs less improved), and 4) Evaluate whether subjects are able to distinguish between true acupuncture and the sham acupuncture method used in this study. Confounders to be measured include type and duration of chemotherapy, psychological distress, anemia, level of activity, chemotherapy-induced amenorrhea and other estrogen deficiency states, use of pharmacologic agents for fatigue, type of surgery, use of medications that may worsen fatigue, and concomitant illness. The primary outcome variable is cancer-related fatigue based on the FACIT-F. Secondary outcomes are fatigue severity measured by the Brief Fatigue Inventory, quality of life measured by the SF-36, and distress from the cancer related fatigue, measured by the Cancer-related Fatigue Distress Scale. Although we have powered the study to be able to detect a difference between true and sham acupuncture, the effect sizes could not be based on previous studies. This pilot study will enable a larger, more rigorous, well-controlled research study on the efficacy of acupuncture for cancer-related fatigue.
Project Terms:
acupuncture /acupressure; alternative medicine; breast neoplasms; clinical research; fatigue; female; human subject; human therapy evaluation; neoplasm /cancer radiation therapy; neoplasm /cancer therapy; patient oriented research; psychological stressor; psychometrics; quality of life; therapy design /development; women's health