CI

At a glance

ClinicalIndex Comparison Record
Phase 3Active· 681 enrolled
Drug / intervention
Relaxation Program +2 moreother
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/NCT01202851
NCT01202851Phase 3Active

Biobehavioral Effects of Relaxation for Women With Breast Cancer Undergoing Radiotherapy

M.D. Anderson Cancer Center·interventional·Posted Sep 16, 2010·Updated May 5, 2026

In Brief

A Phase 3 clinical trial evaluating Relaxation Program, Questionnaires, and 1 other intervention for Breast Cancer. Active but no longer recruiting, targeting 681 participants across 1 site.

Detailed Summary

The goal of this behavioral research study is to compare two different forms of relaxation programs that will include stretching and relaxation techniques, in order to learn if and how well they may help to improve physical and emotional well-being. This will be tested in patients with breast cancer who are receiving radiation therapy. For comparison purposes, there will also be a group of participants that does not take part in the relaxation programs. This is an investigational study. The relaxation programs are being compared for research purposes only. An "assessment" is any time you complete a set of scheduled activities for this study, such as tests and questionnaires. Up to 700 patients will take part in this study. All will be enrolled at MD Anderson.

Study Details

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

Timeline

Phase 3Active
201120122013201420152016201720182019202020212022202320242025202620272028
First PostedSep 16, 2010
Enrollment StartFeb 10, 2011
Primary CompletionFeb 28, 2028
TodayJul 1, 2026
Enrollment to primary: 17.1 yearsPosted 15.8 years agoPrimary completion in 1.7 years

Interventions

Relaxation Programother

3 times a week, 60 minute sessions for 6 weeks.

Questionnairesbehavioral

Multiple questionnaires taken before, during and after radiotherapy/exercise intervention programs during course of study.

Saliva Testingother

4 saliva samples per day for cortisol testing for 3 days before radiation therapy begins, for 3 days in the last week of radiation therapy, for 3 days in a row 3 months after radiation therapy ended, for 3 days in a row, for 6 months after radiation therapy ended, and for 12 months after radiation therapy ended.