Effects of Yoga in Breast Cancer Patients

Summary

In this study researchers will examine the initial efficacy of implementing a yoga program for patients with breast cancer as an adjuvant to their radiotherapy. Patients with breast cancer who are undergoing radiotherapy will be randomly assigned to either a yoga group (YG), or a stretching (ST) control group, or a waitlist control (WL) group. Participants in YG and ST groups will attend three sessions each week throughout their 6-week radiotherapy schedule. The sessions will be coordinated with the treatment schedule and conducted adjacent to the treatment facility. Measures will be obtained prior to randomization, a brief assessment during the middle of radiation therapy, during the last week of radiation therapy, and 1, 3 and 6 months after the last radiation session. With the inclusion of two control groups in this randomized trial researchers will attempt to validate the benefits of yoga as an adjuvant to radiotherapy in patients with breast cancer wherein researchers will control for specific components of the yoga program and also examine some of the mechanisms that are necessary for the program to be effective.

Our specific aims in the proposed study are to:

* Conduct an initial evaluation of whether participation in the yoga program improves patients' fatigue and sleep disturbances. Fatigue and sleep will be assessed with self-report measures and the use of actigraphy for a more objective measure of sleep quality.
* Secondary end points will include examining QOL, mental health and objective physiological outcomes (blood samples for immune measures, saliva samples for cortisol levels, and heart rate variability).
* Exploratory analyses will examine some plausible mediators of the yoga program including cognitive processing, spirituality, and finding meaning in the cancer experience.

Conditions

• Breast Cancer

Interventions

BEHAVIORAL

Yoga Group

3 sessions of yoga each week for 6 weeks.

BEHAVIORAL

Stretching Control Group

3 sessions of stretching each week for 6 weeks

BEHAVIORAL

Waitlist Control Group

Option of participating in the yoga or stretching program after the study has ended.

OTHER

Questionnaire

Questionnaire evaluating treatment-related symptoms during the middle of radiotherapy.

Sponsors & Collaborators

• National Institutes of Health (NIH)

  collaborator NIH

• National Cancer Institute (NCI)

  collaborator NIH

• M.D. Anderson Cancer Center

  lead OTHER

Principal Investigators

• Lorenzo Cohen, PhD · M.D. Anderson Cancer Center

Study Design

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2006-03-09

Primary Completion

2022-08-11

Completion

2022-08-11

Countries

• United States

Study Locations