NCT06767475

Mindfulness-Based Stress Reduction to Improve Well-being in Black Adult Cancer Survivors, Community Faith-based Mindfulness Ministry

Effectiveness of Mindfulness-Based Intervention on Patient Reported Outcomes of Black Adult Cancer Survivors: A Community Faith-based Mindfulness Ministry (ComFaMM) Trial

• Status: Enrolling By Invitation
• Phase: N/A
• Study type: Interventional
• Enrollment: 115 (estimated)
• Sponsor: Mayo Clinic · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

PRIMARY OBJECTIVES: I. Develop a culturally adapted Mindfulness-Based Stress Reduction (MBSR) intervention. (Phase 0) II. Pilot test the MBSR intervention to assess its feasibility, acceptability, and preliminary efficacy among a small group of participants. (Phase 0) OUTLINE: PHASE 0: INTERVENTION DEVELOPMENT: Participants 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. After completion of study intervention, patients are followed up at 3 months. PHASE 1: 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. PHASE 2: Patients are randomized to 1 of 2 groups. GROUP I (INTERVENTION): 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 II (CONTROL): Patients receive usual care on study. After completion of study intervention, patients are followed up at 3 and 6 months.

Conditions

• Hematopoietic and Lymphatic System Neoplasm
• Malignant Solid Neoplasm

Interventions

Type	Name	Description
OTHER	Best Practice	Receive usual care
OTHER	Discussion	Attend a focus group
OTHER	Health Promotion	Participate in group discussion with exercises and activities
OTHER	Interview	Attend a one-on-one interview
OTHER	Questionnaire Administration	Ancillary studies

Timeline

• Start date: 2024-12-31
• Primary completion: 2028-12-31
• Completion: 2028-12-31
• First posted: 2025-01-10
• Last updated: 2025-05-11

Locations

1 site across 1 country: United States