Stress-Reduction Program for Breast Cancer

Overseen By Cobi J. Heijnen, PHD

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: M.D. Anderson Cancer Center

Must not be taking: Adrenergic antagonists, Corticosteroids

Disqualifiers: Thought disorder, Meditation, Psychotherapy, Autoimmune, others

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

Compensation: Varies

Number of Visits: 5

62 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

If you are currently taking adrenergic receptor antagonists (like propranolol) or corticosteroids (like dexamethasone), you will need to stop these medications to participate in the trial.

What data supports the effectiveness of the Stress-Reduction Intervention treatment for breast cancer?

Research shows that stress-reduction programs like the SMART program can improve resilience, reduce stress and anxiety, and enhance quality of life in women with breast cancer. Additionally, mindfulness-based stress reduction has been effective in treating sleep disturbances in these patients. ^{1 2 3 4 5}

How does the Stress-Reduction Intervention treatment for breast cancer differ from other treatments?

The Stress-Reduction Intervention for breast cancer is unique because it focuses on managing stress through cognitive behavioral techniques and lifestyle modifications, rather than using medication. This approach helps improve patients' confidence in coping with stress and enhances their quality of life, which is different from traditional treatments that primarily target the cancer itself. ^{2 4 6 7 8}

What is the purpose of this trial?

The goal of this research study is to learn if starting a stress-reduction program before treatment can affect your stress, mood, and physical symptoms during and after treatment for cancer. This is an investigational study. Up to 140 participants will be enrolled in this study. All participants will be recruited at MD Anderson.

Research Team

Keri Schadler, PHD

Principal Investigator

M.D. Anderson Cancer Center

Eligibility Criteria

This trial is for women over 18 with stage I-III breast cancer who are about to start chemotherapy. Participants must speak English, be able to consent, follow study procedures, and have access to a device that supports the Headspace app. It's not for those with autoimmune diseases, current psychotherapy or meditation practices, or taking certain medications.

Inclusion Criteria

I am a woman with early to locally advanced breast cancer advised to have chemotherapy before surgery.

I can use Headspace on my phone, tablet, or computer.

Patients who agree to comply with all study procedures

Exclusion Criteria

I am currently undergoing psychotherapy.

You have been diagnosed with certain types of inflammatory autoimmune diseases like rheumatoid arthritis, lupus, or multiple sclerosis.

I am currently taking medications like propranolol or corticosteroids.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2 weeks

1 visit (in-person)

Pre-Treatment Mind-Body Exercises

Participants in Group 1 perform daily mind-body exercises for 14 days before starting chemotherapy

2 weeks

Daily exercises (virtual)

Chemotherapy

Participants receive chemotherapy and complete questionnaires at baseline, third month, and sixth month

6 months

3 visits (in-person or virtual)

Follow-up

Participants are monitored for stress, mood, and physical symptoms after chemotherapy

6 months

1 visit (in-person or virtual)

Treatment Details

Interventions

• Stress-Reduction Intervention

Trial Overview The study tests if starting stress-reduction exercises before cancer treatment can help manage stress, mood swings, and physical symptoms during and after therapy. Participants will use mind-body exercises through an app alongside regular questionnaires.

Participant Groups

Group I: Standard of Care Experimental Treatment 1 Intervention

Questionnaires completed at baseline, at third and at last cycle of chemotherapy, and 6 months after chemotherapy.

Group II: Mind-Body Exercises Experimental Treatment 2 Interventions

Participants do daily mind-body exercises for 14 days before starting chemotherapy. The exercises are presented on an online application ("app") that runs on participant's personal electronic device (such as a mobile phone or tablet). Questionnaires completed at baseline, at third and at last cycle of chemotherapy, and 6 months after chemotherapy.

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3,107

Recruited

1,813,000+

Hackett Foundation

Collaborator

Trials

1

Recruited

60+

Findings from Research

The SMART (Stress Management and Resiliency Training) program significantly improved resilience, reduced perceived stress and anxiety, and enhanced quality of life in 25 women with breast cancer over a 12-week period, compared to a control group.

The intervention, which included group training sessions and follow-up calls, was found to be feasible and effective, indicating that brief resilience training can be beneficial for breast cancer patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stress Management and Resilience Training (SMART) program to decrease stress and enhance resilience among breast cancer survivors: a pilot randomized clinical trial. Loprinzi, CE., Prasad, K., Schroeder, DR., et al.[2022]

A randomized controlled trial involving 60 women with breast cancer showed that a supportive program significantly improved problem-oriented coping strategies and reduced stress levels compared to a control group.

The intervention, which included education, relaxation techniques, and stress management over six weekly sessions, effectively enhanced coping mechanisms and emotional well-being in participants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of a supportive program on coping strategies and stress in women diagnosed with breast cancer: A randomized controlled clinical trial. Samami, E., Elyasi, F., Mousavinasab, SN., et al.[2021]

An online cognitive behavioral stress management intervention for early-stage breast cancer survivors significantly improved self-efficacy in coping with cancer and regulating negative mood after 10 weeks compared to a waitlist control group.

Participants in the intervention group also reported lower levels of cancer-related post-traumatic symptoms, indicating that this online approach can effectively support psychological well-being in breast cancer patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An online stress management workbook for breast cancer. Carpenter, KM., Stoner, SA., Schmitz, K., et al.[2022]

References

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

The efficacy of mindfulness-based stress reduction in the treatment of sleep disturbance in women with breast cancer: an exploratory study. [2022]

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

Stress Management and Resilience Training (SMART) program to decrease stress and enhance resilience among breast cancer survivors: a pilot randomized clinical trial. [2022]

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

Costs and Effectiveness of Mindfulness-Based Art Therapy versus Standard Breast Cancer Support Group for Women with Cancer. [2022]

4. Iran pubmed.ncbi.nlm.nih.gov

The Effect of Stress Management Model in Quality of Life in Breast Cancer Women. [2020]

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

The effect of a supportive program on coping strategies and stress in women diagnosed with breast cancer: A randomized controlled clinical trial. [2021]

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

An online stress management workbook for breast cancer. [2022]

7. 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]

8. Iran pubmed.ncbi.nlm.nih.gov

Effect of Perceptual Stress Reduction Control Intervention on the Level of Symptoms in Breast Cancer at Different Time Points. [2022]