CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 191 enrolled
Drug / intervention
Yoga Group +3 morebehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00508794
NCT00508794N/ACompleted

Biobehavioral Effects of Yoga During Breast Cancer Treatment

M.D. Anderson Cancer Center·interventional·Posted Jul 30, 2007·Updated Sep 1, 2022

In Brief

A clinical study evaluating Yoga Group, Stretching Control Group, and 2 other interventions for Breast Cancer. Completed, enrolled 191 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBreast Cancer
CountriesUnited States

Timeline

N/ACompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJul 30, 2007
Enrollment StartMar 9, 2006
Primary CompletionAug 11, 2022
TodayJul 1, 2026
Enrollment to primary: 16.4 yearsPosted 18.9 years ago

Interventions

Yoga Groupbehavioral

3 sessions of yoga each week for 6 weeks.

Stretching Control Groupbehavioral

3 sessions of stretching each week for 6 weeks

Waitlist Control Groupbehavioral

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

Questionnaireother

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