Relaxation Program for Breast Cancer

Age: 18+

Sex: Female

Trial Phase: Phase 3

Sponsor: M.D. Anderson Cancer Center

Disqualifiers: Major psychiatric diagnoses, No surgery, Extreme mobility issues, Yoga practice, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 7

681 Participants Needed

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.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It seems to focus on relaxation programs, so it's likely you can continue your medications, but please confirm with the study team.

What data supports the effectiveness of the Relaxation Program treatment for breast cancer?

Research shows that relaxation training can help reduce anxiety, depression, and other negative feelings in cancer patients, including those undergoing chemotherapy for breast cancer. It also helps lessen physical side effects like nausea and high blood pressure, improving overall well-being during treatment. ^{1 2 3 4 5}

Is the Relaxation Program safe for humans?

Research shows that relaxation programs, including muscle relaxation and guided imagery, are generally safe and can help reduce anxiety and other negative reactions during cancer treatments like chemotherapy. ^{3 4 5 6 7}

How does the relaxation program for breast cancer differ from other treatments?

The relaxation program for breast cancer is unique because it focuses on improving mental health and quality of life through techniques like muscle relaxation and stress management, rather than directly targeting the cancer itself. This approach helps patients cope with the psychological demands of cancer, reducing depression, anxiety, and stress, which are common during treatment. ^{2 6 8 9 10}

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

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.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1 week

1 visit (in-person)

Radiation Therapy

Participants undergo radiation therapy while participating in relaxation programs or control group activities

4-6 weeks

3-5 sessions per week (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including questionnaires and saliva testing

12 months

Questionnaires and saliva samples at 3, 6, and 12 months post-radiotherapy

Maintenance Intervention

Participants in the maintenance intervention arm receive telephone counseling and booster sessions post-radiotherapy

12 months

Treatment Details

Interventions

• Relaxation Program

Trial Overview 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.

Participant Groups

Group I: Waitlist Control Group (WLC) Experimental Treatment 2 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 2 Experimental Treatment 3 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 1 Experimental Treatment 3 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.

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3,107

Recruited

1,813,000+

National Institutes of Health (NIH)

Collaborator

Trials

2,896

Recruited

8,053,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

References

1. England pubmed.ncbi.nlm.nih.gov

The effectiveness of relaxation training in reducing treatment-related symptoms and improving emotional adjustment in acute non-surgical cancer treatment: a meta-analytical review. [2019]

2. United States pubmed.ncbi.nlm.nih.gov

Forming a Stress Management and Health Promotion Program for Women Undergoing Chemotherapy for Breast Cancer: A Pilot Randomized Controlled Trial. [2018]

3. United States pubmed.ncbi.nlm.nih.gov

Relaxation training during chemotherapy for breast cancer improves mental health and lessens adverse events. [2021]

4. Germany pubmed.ncbi.nlm.nih.gov

[Development and Evaluation of a Manualized Body-Psychotherapeutic Group Intervention with Functional Relaxation for Patients with Cancer "Calm with Body and Soul"]. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Effectiveness of relaxation training in reducing adverse reactions to cancer chemotherapy. [2019]

6. China pubmed.ncbi.nlm.nih.gov

A systematic review and meta-analysis of the effects of muscle relaxation training vs. conventional nursing on the depression, anxiety and life quality of patients with breast cancer. [2022]

7. Germany pubmed.ncbi.nlm.nih.gov

Impact of relaxation training according to the Yoga In Daily Life® system on anxiety after breast cancer surgery. [2017]

8. India pubmed.ncbi.nlm.nih.gov

The effects of relaxation on reducing depression, anxiety and stress in women who underwent mastectomy for breast cancer. [2021]

9. England pubmed.ncbi.nlm.nih.gov

Relaxation training as a technique for helping patients cope with the experience of cancer: a selective review of the literature. [2019]

10. United States pubmed.ncbi.nlm.nih.gov

Stress management intervention reduces serum cortisol and increases relaxation during treatment for nonmetastatic breast cancer. [2022]