Apr 13 2010
Phase III trial will study efficacy of incorporating mind-body intervention into breast cancer treatment, cost-benefit and work productivity
In an ongoing effort to scientifically validate the age-old belief that mind-body interventions have a beneficial impact on the health of patients, The University of Texas M. D. Anderson Cancer Center has been awarded more than $4.5 million to study the efficacy of incorporating yoga into the treatment program of women with breast cancer.
The grant, the largest ever awarded by the National Cancer Institute for the study of yoga in cancer, will allow researchers to conduct a Phase III clinical trial in women with breast cancer to determine the improvement in physical function and quality-of-life during and after radiation treatment. It will also investigate if such stress reduction programs result in economic and/or work productivity benefit.
Lorenzo Cohen, Ph.D., professor and director of M. D. Anderson's integrative medicine program, received the funding.
"Research has shown that yoga and other types of mind-body practices, incorporated into the standard of care, can help improve patient outcomes, particularly quality-of-life," said Cohen, the study's principal investigator. "However, none have become standard of care, or are on the clinical care pathway for cancer patients. This funding will allow us to definitively determine the benefit of incorporating yoga into treatment plan for women with breast cancer."
The research is being done in collaboration with the Vivekananda Yoga Anusandhana Samsthana (VYASA), a yoga research foundation and university in Bangalore, India. M. D. Anderson has been collaboration with VYASA for more than six years.
Two previous studies led by Cohen and colleagues investigating yoga in similar populations of breast cancer patients have shown benefits in physical function, compared to women who did simple stretching and/or those who did not participate in any such program. Patients who participated in the yoga program reported that their ability to engage in everyday activities - walking a flight of stairs or around the block, carrying a bag of groceries - all improved, said Cohen. The study also found an indication of improved sleep and reduced fatigue levels, and preliminary analysis suggests lowered stress hormone levels in the yoga group.
Building on such research, the Phase III study will enroll 600 women with stage 0-3 breast cancer, all undergoing radiation at M. D. Anderson. The women will be randomized to one of three groups: yoga (YG), stretching/relaxation (STR) or those who receive the standard of care and do not enroll in any exercise program, the waitlist control (WLC). Participants in both the yoga and stretching groups will attend sessions three days a week throughout their six weeks of radiation.
Participants will self-report quality-of-life aspects, including physical function, mental health and fatigue levels. In addition to reporting their sleep quality, patients also will wear an activity watch monitor that objectively monitors the restfulness of their sleep. Cortisol levels will also be collected and studied, as blunted cortisol slopes have been linked to worse outcomes in breast cancer, said Cohen.
A secondary aim of the trial, but one of great importance, stressed Cohen, is assessing cost efficiency analysis for the hospital, and health care utilization costs in general, as well as examining work productivity of patients.
"In this age of health care reform, it's very important to determine the cost savings, not only to the hospital, but to also to women's lives and their ability to engage in their work in a productive fashion, whether that's the work of being a mother and running a household or working outside the home," said Cohen. "By including such data as cost-effectiveness analyses, we may be able to change the standard of care the way women with breast cancer are treated in this country."
Source: University of Texas M. D. Anderson Cancer Center
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