Pain is one the most frequent, distressing, and debilitating symptoms experienced by women with metastatic breast cancer. Pain is associated with a host of other symptoms including fatigue, sleep disturbance, psychological distress, and functional impairments. Despite medical advances in treating cancer pain, many patients do not experience adequate pain relief. Yoga-based interventions have shown promise for improving the management of pain and pain-related symptoms but have not been tested in the context of metastatic breast cancer or any advanced cancer. Given the high pain and symptom burden associated with metastatic breast cancer, it is imperative to develop palliative interventions to enhance the quality of these women?s lives. We recently conducted a pilot study to test a novel and comprehensive yoga-based symptom management protocol that combines gentle physical postures (asanas), conscious breathing (pranayama), and meditation techniques (dhyana) specifically designed to address pain and pain-related symptoms commonly experienced in metastatic breast cancer. Data from a small uncontrolled pilot study supported the feasibility of the intervention. The proposed project seeks to more definitely test the feasibility, acceptability, and preliminary efficacy of a comprehensive yoga-based symptom management protocol for women with metastatic breast cancer who are experiencing pain. In this trial, 60 women will be randomly assigned to either the yoga intervention (n=40) or a social support control intervention (n=20). Women in both conditions will attend eight weekly two-hour group sessions.
The aims of the study are to determine the feasibility and acceptability of the yoga intervention, to examine the relationship between dose of yoga practice and participant baseline characteristics, and to provide preliminary data on the efficacy of the yoga intervention to improve pain-related symptoms and overall pain. Assessments conducted before and after treatment and at 3-months and 6-months follow up will include patient reports of pain, fatigue, sleep disturbance, and psychological distress, and a behavioral measure of functional capacity. Additional measures will be collected via daily diary throughout the intervention period.

Public Health Relevance

Pain is a major concern of patients with metastatic breast cancer (MBC) and is associated with symptoms including fatigue, sleep disturbance, psychological distress, and reduced function. Yoga interventions have shown promise for managing pain in patients with a variety of medical conditions but have not yet been tested in women with MBC. This study will test the efficacy of a comprehensive yoga-based pain management intervention developed specifically for patients with MBC. If successful, it will provide evidence for the use of yoga to manage pain and pain- related symptoms in MBC.

Agency
National Institute of Health (NIH)
Type
Research Project (R01)
Project #
5R01AT007572-02
Application #
8726903
Study Section
Behavioral Medicine, Interventions and Outcomes Study Section (BMIO)
Program Officer
Alekel, D Lee
Project Start
Project End
Budget Start
Budget End
Support Year
2
Fiscal Year
2014
Total Cost
Indirect Cost
Name
Duke University
Department
Psychiatry
Type
Schools of Medicine
DUNS #
City
Durham
State
NC
Country
United States
Zip Code
27705