Mindfulness-Based Stress Reduction for Cancer Survivors

(ComFaMM Trial)

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Mayo Clinic

Disqualifiers: Medical, psychological hardship, others

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

Compensation: Varies

Number of Visits: 11

115 Participants Needed

Trial Summary

Do I have to stop taking my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It seems likely that you can continue your medications, but it's best to confirm with the trial organizers.

What data supports the effectiveness of the treatment Mindfulness-Based Stress Reduction for cancer survivors?

Research shows that Mindfulness-Based Stress Reduction (MBSR) can help breast cancer survivors by reducing stress and improving their quality of life. Studies have found that MBSR, which includes meditation and focus exercises, is effective in managing symptoms and enhancing well-being in these patients. ^{1 2 3 4 5}

Is Mindfulness-Based Stress Reduction (MBSR) safe for cancer survivors?

Mindfulness-Based Stress Reduction (MBSR) is generally considered safe for cancer survivors, as studies have shown it helps reduce stress, anxiety, and depression without reporting any significant adverse effects. ^{2 5 6 7 8}

How is Mindfulness-Based Stress Reduction different from other treatments for cancer survivors?

Mindfulness-Based Stress Reduction (MBSR) is unique because it focuses on using meditation and awareness exercises to help cancer survivors manage stress and improve their quality of life, rather than relying on medication or physical treatments. It emphasizes being present and accepting things as they are, which can lead to feeling calmer and more connected. ^{2 3 5 6 8}

What is the purpose of this trial?

This clinical trial evaluates the impact of a Mindfulness-Based Stress Reduction (MBSR) program adjusted to include Christian principles on well-being in Black adult cancer survivors. Cancer survivors face a unique set of challenges that includes not only physical but also mental and spiritual well-being. Concerns related to both diagnosis and treatment profoundly impact the quality of life of Black cancer survivors. Mindfulness-based interventions (MBIs) have been shown to be effective in improving psychological resilience, reducing anxiety, and enhancing the quality of life among cancer survivors. However, there is little research focusing on these interventions among Black adult cancer survivors. Research has shown that interventions that include cultural experiences, such as the role of religion, spirituality and faith, are more effective in maintaining psychological well-being in Black men. A MBSR program adjusted to include Christian principles may improve the well-being in Black adult cancer survivors.

Research Team

Floyd B. Willis, MD

Principal Investigator

Mayo Clinic

Eligibility Criteria

This trial is for Black adult cancer survivors interested in a program that combines mindfulness with Christian principles to improve mental, spiritual, and overall well-being. Specific eligibility criteria are not provided.

Inclusion Criteria

PHASE 0 DEVELOPMENT: Membership or affiliation with a faith-based organization

PHASE 0 PILOT TESTING: Ability to speak, read and understand English

I can attend in-person sessions and complete online surveys.

Exclusion Criteria

PHASE 0 DEVELOPMENT: Does not meet the inclusion criteria

I cannot attend MBI sessions due to health or psychological reasons.

I cannot attend MBI sessions due to health or emotional issues.

Timeline

Intervention Development

Participants attend a focus group or a one-on-one interview to gather insights of the cultural needs of Black adult cancer survivors

Up to 60 minutes

1 visit (in-person or virtual)

Pilot Testing

Patients participate in a group discussion with exercises and activities to assess feasibility, acceptability, and preliminary efficacy

Not specified

1 visit (in-person)

Phase 1

Patients participate in group discussions, exercises, and activities over no more than 8 hours for up to 3 sessions

8 weeks

Up to 3 visits (in-person)

Phase 2

Patients are randomized to either the intervention group or control group, participating in group discussions, exercises, and activities

Not specified

Up to 3 visits (in-person)

Follow-up

Participants are monitored for outcomes such as spiritual well-being, quality of life, and resilience

Up to 6 months

Follow-up at 3 and 6 months

Treatment Details

Interventions

• Mindfulness-Based Stress Reduction

Trial Overview The study tests a Mindfulness-Based Stress Reduction (MBSR) program tailored with Christian values to see if it helps Black cancer survivors feel better mentally and spiritually.

Participant Groups

Group I: Phase 1 (MBSR) Experimental Treatment 2 Interventions

Patients participate in group discussions, exercises, and activities over no more than 8 hours for up to 3 sessions (up to 16 hours total) within 8 weeks.

Group II: Phase 0 (intervention development, pilot testing) Experimental Treatment 4 Interventions

INTERVENTION DEVELOPMENT: Participants may attend a focus group or a one-on-one interview over up to 60 minutes to gather insights of the cultural needs of Black adult cancer survivors. PILOT TESTING: Patients participate in a group discussion with exercises and activities on study.

Group III: Group I (MBSR) Experimental Treatment 2 Interventions

Patients participate in group discussions, exercises, and activities over no more than 8 hours for up to 3 sessions (up to 16 hours total).

Group IV: Group II (control) Active Control 2 Interventions

Patients receive usual care on study.

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+

Findings from Research

Mindfulness-based stress reduction (MBSR) significantly improves various aspects of health in breast cancer patients, including emotional well-being, cognitive function, and reduces anxiety and depression, based on a systematic review of 14 studies with 1505 participants.

MBSR is recommended as a complementary treatment for breast cancer patients, although its effects on pain, sleep quality, and overall quality of life were not statistically significant.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of mindfulness-based stress reduction (MBSR) on symptom variables and health-related quality of life in breast cancer patients-a systematic review and meta-analysis. Zhang, Q., Zhao, H., Zheng, Y.[2020]

The study investigates the effectiveness of mindfulness-based stress reduction (MBSR) as a complementary health approach for breast cancer survivors, focusing on its potential to reduce stress and enhance present-moment awareness.

The research aims to assess whether there is sufficient evidence and consistent methodologies to support the use of MBSR specifically for this population, highlighting the need for standardized outcomes in future studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mindfulness as an Intervention for Breast Cancer Survivors. Kiely, D., Schwartz, S.[2017]

The modified mindfulness-based stress reduction (MBSR) program for breast cancer patients showed promising effects on reducing psychological distress and improving quality of life, with significant improvements noted in distress, general wellbeing, and fatigue-related quality of life after 8 weeks.

Although the study did not meet its feasibility goals for enrollment and retention, 66.7% of participants completed at least 7 out of 8 sessions, indicating potential interest and benefit in mindfulness interventions for cancer recovery in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prospective feasibility study of a mindfulness-based program for breast cancer patients in the southeastern US. Salvador, C., Mark, P., Hoenemeyer, T., et al.[2022]

Mindfulness-Based Stress Reduction (MBSR) shows promise in improving mood, sleep quality, and reducing stress in cancer patients, based on a systematic review of three randomized controlled trials and seven uncontrolled trials.

Despite positive outcomes, the review highlights methodological limitations, such as variations in study designs and a lack of controlled studies, indicating that more rigorous research is needed to firmly establish the efficacy and safety of MBSR for cancer supportive care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mindfulness-Based Stress Reduction as supportive therapy in cancer care: systematic review. Smith, JE., Richardson, J., Hoffman, C., et al.[2018]

Mindfulness-based stress reduction (MBSR) has shown large effect sizes in reducing perceived stress and state anxiety among breast cancer survivors, based on a review of 16 quantitative studies.

While MBSR had smaller effects on biological outcomes, it significantly improved cytokine production at 6- and 12-month follow-ups, suggesting potential long-term benefits for immune function.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mindfulness-based stress reduction among breast cancer survivors: a literature review and discussion. Matchim, Y., Armer, JM., Stewart, BR.[2022]

An 8-week internet-based Mindfulness-based Stress Reduction (iMBSR) program significantly reduced symptoms of depression, anxiety, and insomnia in 48 breast cancer survivors compared to those who did not participate.

Participants who practiced mindfulness for more than 30 minutes daily experienced the greatest improvements, suggesting a dose-response relationship where increased practice time leads to better psychological outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Psychological Effect of Internet-Based Mindfulness-Based Stress Reduction on the Survivors of Breast Cancer During the COVID-19. Kang, C., Sun, S., Yang, Z., et al.[2021]

References

1. Germany pubmed.ncbi.nlm.nih.gov

Effectiveness of mindfulness-based stress reduction (MBSR) on symptom variables and health-related quality of life in breast cancer patients-a systematic review and meta-analysis. [2020]

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

Mindfulness as an Intervention for Breast Cancer Survivors. [2017]

3. England pubmed.ncbi.nlm.nih.gov

Prospective feasibility study of a mindfulness-based program for breast cancer patients in the southeastern US. [2022]

4. England pubmed.ncbi.nlm.nih.gov

Mindfulness-Based Stress Reduction as supportive therapy in cancer care: systematic review. [2018]

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

Mindfulness-based stress reduction among breast cancer survivors: a literature review and discussion. [2022]

6. Japan pubmed.ncbi.nlm.nih.gov

A meta-analysis of the benefits of mindfulness-based stress reduction (MBSR) on psychological function among breast cancer (BC) survivors. [2022]

7. Switzerland pubmed.ncbi.nlm.nih.gov

The Psychological Effect of Internet-Based Mindfulness-Based Stress Reduction on the Survivors of Breast Cancer During the COVID-19. [2021]

8. England pubmed.ncbi.nlm.nih.gov

Mindfulness-based stress reduction in breast cancer: a qualitative analysis. [2022]