Relaxation Program for Breast Cancer

Recruiting in Palo Alto (17 mi)

Lorenzo G Cohen | MD Anderson Cancer Center

Overseen byLorenzo Cohen

Age: 18+

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: M.D. Anderson Cancer Center

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?

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.

Research Team

Lorenzo Cohen

Principal Investigator

M.D. Anderson Cancer Center

Eligibility Criteria

This trial is for women aged 18 or older with stage 0 - III breast cancer, who are about to start daily radiation therapy for 4-6 weeks. Participants must be able to communicate in English or Spanish. It's not open to those who've practiced yoga recently, have significant mobility issues, major psychiatric conditions like schizophrenia or bipolar disorder, or haven't had surgery for their cancer.

Inclusion Criteria

I and my spouse/partner are both 18 years old or older.

I am a woman with early to locally advanced breast cancer scheduled for daily radiation therapy for 4-6 weeks.

Able to read, write, and speak English or Spanish (patient and spouse/partner)

Exclusion Criteria

You have practiced yoga or similar mind-body activities in the past year or are currently doing so.

I cannot move in and out of a chair without help.

You have been diagnosed with serious mental illnesses like schizophrenia or bipolar disorder.

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Treatment Details

Interventions

Relaxation Program (Behavioral Intervention)

Trial OverviewThe study is testing two different relaxation programs involving stretching and relaxation techniques against a control group with no such program. The aim is to see if these programs improve the physical and emotional well-being of women undergoing radiation therapy for breast cancer.

Participant Groups

3Treatment groups

Experimental Treatment

Group I: Waitlist Control Group (WLC)Experimental Treatment2 Interventions

Participants in this group given the option to take part in one of the two forms of relaxation (off study) after they finish their last questionnaire packet. 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.

Group II: Relaxation Group 2Experimental Treatment3 Interventions

Simple stretching exercises, specific breathing skills, and guided relaxation for 3 sessions, 3 times a week for 6 weeks. Each session should last about 60 minutes. Multiple questionnaires taken before, during and after radiotherapy/exercise intervention programs during course of study. 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.

Group III: Relaxation Group 1Experimental Treatment3 Interventions