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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how a mindfulness program incorporating Christian principles can improve the well-being of Black adult cancer survivors. Cancer survivors often encounter physical, mental, and spiritual challenges, and this program aims to enhance their quality of life by reducing stress and anxiety. Participants will engage in group activities and discussions designed to boost resilience. Suitable candidates have experienced cancer, identify as Black or African American, and are connected to a faith-based organization. As an unphased trial, participants contribute to valuable research that may enhance support for cancer survivors.

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 prior data suggests that this Mindfulness-Based Stress Reduction program is safe for Black adult cancer survivors?

Research shows that Mindfulness-Based Stress Reduction (MBSR) is a safe and well-accepted method for cancer survivors. Studies have found that MBSR can improve quality of life by reducing stress, anxiety, and depression in cancer patients and survivors. For instance, in one study, cancer survivors who participated in an MBSR program reported better focus and overall well-being. Importantly, these studies did not identify any major negative effects from MBSR, indicating its safety. Overall, MBSR appears to be a promising way to enhance the mental and emotional health of cancer survivors without significant safety concerns. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Mindfulness-Based Stress Reduction (MBSR) for cancer survivors because it offers a holistic approach to managing stress, unlike traditional treatments that often focus solely on medication or therapy. MBSR involves group discussions, exercises, and activities that aim to enhance mental well-being and resilience, potentially improving quality of life without the side effects associated with pharmaceuticals. Additionally, this approach considers the cultural needs of Black adult cancer survivors, aiming to tailor interventions that resonate more personally and effectively with diverse populations. This personalized, non-invasive method could complement existing cancer care, offering a new avenue for emotional and psychological support.

What evidence suggests that this Mindfulness-Based Stress Reduction program is effective for improving well-being in Black adult cancer survivors?

Research has shown that Mindfulness-Based Stress Reduction (MBSR), which participants in this trial may receive, can improve the mental well-being of cancer survivors. Studies have found that MBSR reduces feelings of depression, anxiety, and stress. Cancer patients who practice mindfulness often report better social support, improved overall well-being, and enhanced spiritual health. A review of multiple studies found that MBSR significantly reduces cancer-related fatigue in breast cancer patients. Additionally, MBSR improved anxiety more effectively than standard care in breast cancer patients. These findings suggest that MBSR can be a valuable tool for enhancing the well-being of cancer survivors. ^{6 7 8 9 10}

Who Is on the Research Team?

Floyd B. Willis, MD

Principal Investigator

Mayo Clinic

Are You a Good Fit for This Trial?

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

PHASE 2: Ability to speak, read and understand English

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8200136/

Mindfulness-Based Interventions in Cancer Survivors There were significant improvements in depression (d= 0.83), anxiety (d= 0.59), and stress (d=0.53) scores for MBCT participants compared with ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S0272735824001260

Positive health outcomes of mindfulness-based ... Among cancer patients, these interventions have demonstrated improvements in mindfulness, social support, well-being, meaningfulness, and spirituality (Carlson ...

3. frontiersin.org frontiersin.org/journals/oncology/articles/10.3389/fonc.2025.1585383/pdf

Effect of mindfulness-based stress on cancer-related ... Results: A meta-analysis of 11 studies included showed that MBSR could reduce. CRF in breast cancer patients (SMD = -0.86, 95%CI = −1.22 ~ −0.50) ...

4. 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 results of the meta-analysis showed that MBSR therapy were significantly better than standard care in reducing FOR in breast cancer patients ...

5. bmcpsychology.biomedcentral.com bmcpsychology.biomedcentral.com/articles/10.1186/s40359-024-02092-y

The use of mindfulness-based stress reduction (MBSR) for ... MBSR yielded a substantial improvement in the anxiety for breast cancer patients when compared to the control group; this effect was ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4331267/

Randomized Controlled Pilot Study of Mindfulness-Based ... A sample of 35 cancer survivors with clinically-significant CRF was randomly assigned to a 7-week MBSR-based intervention or wait-list control group. The ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S0022399925002764

Mindfulness-based interventions for cancer patients in ... Mindfulness interventions may improve quality of life in patients with cancer. Mindfulness interventions may decrease cancer-related depression and anxiety.

8. lidsen.com lidsen.com/journals/icm/icm-09-01-019

Effectiveness of Mindfulness-Based Stress Reduction ... MBSR interventions are effective in enhancing mindfulness and alleviating stress or stress-like symptoms in cancer patients and survivors.

9. trialsjournal.biomedcentral.com trialsjournal.biomedcentral.com/articles/10.1186/s13063-016-1335-z

The effectiveness of mindfulness-based stress reduction ... We hope to show that MBSR reduces neuroendocrine stress activation and improves the immune function of BC survivors after the vulnerable periods ...

10. acsjournals.onlinelibrary.wiley.com acsjournals.onlinelibrary.wiley.com/doi/full/10.1002/cncr.34209

Mindfulness‐based stress reduction and cognitive function ... A pilot randomized controlled trial (RCT) in a sample of individuals with cancer found that MBSR had beneficial effects on measures of attention ...