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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether starting a stress-reduction program before breast cancer treatment can alleviate stress, mood, and physical symptoms. Participants will either receive standard care or engage in mind-body exercises through an app for 14 days before chemotherapy. The study targets women with stage I-III breast cancer who are about to begin chemotherapy and can use a smartphone, tablet, or computer. As an unphased trial, it offers participants the chance to contribute to innovative research that may enhance stress management during cancer treatment.

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 prior data suggests that this stress-reduction program is safe for breast cancer patients?

Research shows that exercises like yoga, which connect the mind and body, are generally safe and well-tolerated by breast cancer patients. Studies have found that these exercises can improve mental health and overall quality of life. They can reduce anxiety, depression, and fatigue, which are common issues for cancer patients.

Current evidence suggests that mind-body exercises are not only safe but also somewhat effective in managing symptoms for cancer survivors. Reports of negative effects are rare, indicating they usually don't cause harm or unwanted side effects.

In summary, mind-body exercises appear to be a safe option for those undergoing cancer treatment, with potential benefits for both mental and physical health. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores the potential of mind-body exercises to help breast cancer patients manage stress during chemotherapy. Unlike the standard care, which primarily involves completing questionnaires, this intervention uses an innovative approach by integrating daily exercises through an app on personal devices. This method not only empowers patients to actively participate in their care but also leverages technology to make stress management more accessible and personalized. By potentially reducing stress and improving quality of life, this approach could complement traditional cancer treatments, offering a more holistic care experience.

What evidence suggests that this stress-reduction program is effective for breast cancer patients?

Research shows that exercises like yoga can improve mental and physical well-being in breast cancer patients. Studies have found that these exercises can reduce anxiety, depression, and fatigue. They also appear to ease concerns about cancer recurrence. In this trial, participants in the Mind-Body Exercises arm will engage in mindfulness-based stress reduction, a type of mind-body exercise, which has noticeably helped with early fatigue compared to regular care. Overall, these exercises hold promise in supporting better emotional and physical well-being during breast cancer treatment. ^{1 2 5 6 7}

Who Is on the Research Team?

Keri Schadler, PHD

Principal Investigator

M.D. Anderson Cancer Center

Are You a Good Fit for This Trial?

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

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

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 for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11911294/

The Effectiveness of Mind–Body Exercise on Health ... Mind–body exercises, especially yoga, may be beneficial for improving health‐related quality of life and mental health for breast cancer patients.

2. frontiersin.org frontiersin.org/journals/public-health/articles/10.3389/fpubh.2025.1641075/full

The impact of mind–body exercise on female breast cancer ... Conclusion: Mind–body exercises can effectively alleviate anxiety, depression, and fatigue in breast cancer patients, and appear beneficial in reducing FCR.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11484075/

Effects of mindfulness-based stress reduction on cancer ... Compared with conventional nursing, MBSR had a statistically significant effect on early fatigue in breast cancer patients. After MBSR ...

4. sigmapubs.onlinelibrary.wiley.com sigmapubs.onlinelibrary.wiley.com/doi/abs/10.1111/wvn.70008

The Effectiveness of Mind–Body Exercise on Health‐Related ... Mind–body exercises, especially yoga, may be beneficial for improving health-related quality of life and mental health for breast cancer ...

5. journals.plos.org journals.plos.org/plosone/article?id=10.1371/journal.pone.0306643

Effects of mindfulness-based stress reduction on quality of life ... The findings suggest that MBSR therapy effectively improves anxiety, depression, and emotional state in breast cancer patients after ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7487122/

Effects of Mind-Body Exercise in Cancer Survivors The current evidence demonstrates that mind-body exercise is relatively safe and modestly effective for symptom management in cancer survivors.

7. sciencedirect.com sciencedirect.com/science/article/pii/S0960977624001292

Effect of different exercise types on quality of life in patients ... The effect of yoga and mind–body exercises on the quality of life of patients with breast cancer is inconclusive. Larger, higher-quality randomized ...