Grant Number:	7R21CA100594-03 Interpret this number
Primary Investigator:	Elkins, Gary
Organization:	Baylor University
Project Title:	Hypnosis for Hot Flashes in Breast Cancer Survivors
Fiscal Year:	2005

DESCRIPTION (provided by applicant): Context: Hot flashes are a significant problem for many breast cancer survivors. In fact, 78% of female chemotherapy recipients and 72% of tamoxifen recipients experience hot flashes. Severe hot flashes are reported by a large majority of breast cancer survivors with hot flashes. Further, hot flashes results in discomfort, disrupted sleep, anxiety, and decreased quality of life. The treatment of ovarian failure and hot flashes occurring either premenopausally or postmenopausally has been estrogen replacement therapy for women with no history of breast cancer. However, estrogens have been associated with increased risk of breast cancer and therefore are often avoided for breast cancer survivors. Also, because of this concern many women reject estrogens. Given these facts it is imperative that new interventions be developed to help breast cancer survivors who experience hot flashes. A well-tolerated and effective mind-body treatment for hot flashes would be of great value. We have identified an innovative use of hypnosis that may be of benefit in reducing the frequency and severity of hot flashes in breast cancer survivors. To our knowledge, no studies to date have investigated the use of hypnosis for hot flashes. Objective: Our/long-range goal is to improve the quality of care and relieve suffering among breast cancer patients. The objective of this proposal, which is the next step in attaining our long-range goal, is to conduct a pilot study to evaluate the effect of an innovative use of hypnosis to reduce hot flashes in breast cancer survivors. The central hypothesis of the proposal is that this intervention will result in a significant reduction in hot flashes in breast cancer survivors. Specific Aims: We expect to test our central hypothesis and achieve the objective of this pilot study by pursuing two specific aims: (1) Determine the efficacy of hypnosis in reducing hot flashes in breast cancer survivors. Our working hypothesis is that the hypnosis intervention will result in significant reductions in the frequency and severity of hot flashes. (2) Determine the extent to which hypnotizability is related to the success of the hypnotherapy intervention. We hypothesize that individuals who are higher in their measured hypnotizability will achieve better results with the hypnosis intervention. Design, Setting, and Participants: We will enroll 60 female breast cancer survivors with hot flashes. Participants will be randomly assigned to either a hypnosis treatment group or no-treatment control. Participants in the treatment group will receive 5 individual sessions of hypnosis for hot flashes. We will measure the frequency, severity and impact of hot flashes pre- and post-intervention. The study will be conducted within Scott and White Clinic and Hospital (a 515 physician facility and clinical teaching campus for the Texas A&M University System College of Medicine). Main Outcome Measures: Participants will complete daily dialries of the frequency and severity of hot flashes. Also, participants will record the impact of hot flashes on a weekly basis. The primary outcome will be frequency and severity of hot flashes. We will also determine the extent to which hypnotizability is related to outcomes. Secondary outcomes will be measures of anxiety, depression, sleep, and sexual functioning.





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