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Relaxation Program for Breast Cancer

Phase 3

Waitlist Available

Led By Lorenzo Cohen, PHD

Research Sponsored by M.D. Anderson Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

18 years of age or older (patient and spouse/partner)

Women with stage 0 - III breast cancer who will be undergoing daily adjuvant radiation for 4-6 weeks (patients only)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up prior to and during radiotherapy, through 6 week relaxation program and 12 months post radiotherapy

Awards & highlights

Study Summary

This trial is testing two relaxation techniques to see if they can improve physical and emotional wellbeing for breast cancer patients receiving radiation. Up to 700 people will take part.

Who is the study for?

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.Check my eligibility

What is being tested?

The 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.See study design

What are the potential side effects?

Since this trial involves non-invasive activities like stretching and relaxation exercises, side effects may be minimal but could include muscle soreness or emotional distress.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

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

Select...

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

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ prior to and during radiotherapy, through 6 week relaxation program and 12 months post radiotherapy

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~prior to and during radiotherapy, through 6 week relaxation program and 12 months post radiotherapy

This trial's timeline: 3 weeks for screening, Varies for treatment, and prior to and during radiotherapy, through 6 week relaxation program and 12 months post radiotherapy for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Efficacy of Relaxation Program

Trial Design

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Questionnaires

2013

Completed Phase 2

~3330

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Institutes of Health (NIH)NIH

2,696 Previous Clinical Trials

6,951,898 Total Patients Enrolled

49 Trials studying Breast Cancer

110,104 Patients Enrolled for Breast Cancer

National Cancer Institute (NCI)NIH

13,657 Previous Clinical Trials

40,932,986 Total Patients Enrolled

939 Trials studying Breast Cancer

1,542,679 Patients Enrolled for Breast Cancer

M.D. Anderson Cancer CenterLead Sponsor

2,967 Previous Clinical Trials

1,804,121 Total Patients Enrolled

147 Trials studying Breast Cancer

62,605 Patients Enrolled for Breast Cancer

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does Relaxation Group 2 have government-sanctioned authorization?

"Taking into account the available safety data and efficacy research, Relaxation Group 2 was assigned a score of 3."

Answered by AI

Are recruitment efforts underway for this experimental endeavor?

"Clinicaltrials.gov indicates that this study is not presently recruiting patients, despite having been initially posted on February 10th 2021 and last edited on April 16th 2020. However, there are 2,656 other trials actively seeking participants right now."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Relaxation for Women With Breast Cancer Undergoing Radiotherapy

2011. "Relaxation for Women With Breast Cancer Undergoing Radiotherapy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01202851.

All > Radiotherapy > Mental Health