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

Mayo Clinic

Status: Invitation-only

Conditions: Hematopoietic and Lymphatic System Neoplasm; Malignant Solid Neoplasm

Treatments: Other: Health Promotion; Other: Discussion; Other: Questionnaire Administration; Other: Best Practice; Other: Interview

Study type: Interventional

Funder types: Other

Identifiers

NCT06767475

NCI-2024-10490 (Registry Identifier)

24-006322 (Other Identifier)

MC240901 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 115 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• PHASE 0 DEVELOPMENT: Adults aged 18 or older
• PHASE 0 DEVELOPMENT: Ability to speak, read and understand English
• PHASE 0 DEVELOPMENT: Individuals personally affected by cancer, either through their own diagnosis or that of a loved one
• PHASE 0 DEVELOPMENT: Self-identifies as Black or African American
• PHASE 0 DEVELOPMENT: Membership or affiliation with a faith-based organization
• PHASE 0 PILOT TESTING: Adults aged 18 or older
• PHASE 0 PILOT TESTING: History of a cancer diagnosis
• PHASE 0 PILOT TESTING: Meets National Cancer Institute (NCI) cancer survivor definition (a person is a survivor from the time of diagnosis until the end of life)
• PHASE 0 PILOT TESTING: Ability to physically attend live MBI and complete web-based surveys and assessments
• PHASE 0 PILOT TESTING: Ability to speak, read and understand English
• PHASE 1: Adults aged 18 or older
• PHASE 1: History of a cancer diagnosis
• PHASE 1: Meets NCI cancer survivor definition (a person is a survivor from the time of diagnosis until the end of life)
• PHASE 1: Ability to physically attend live MBI and complete web-based surveys and assessments
• PHASE 1: Ability to speak, read and understand English
• PHASE 2: Adults aged 18 or older
• PHASE 2: History of a cancer diagnosis
• PHASE 2: Meets NCI Cancer Survivor definition (a person is a survivor from the time of diagnosis until the end of life)
• PHASE 2: Ability to physically attend live MBI and complete web-based surveys and assessments
• PHASE 2: Ability to speak, read and understand English

Exclusion criteria

• PHASE 0 DEVELOPMENT: Does not meet the inclusion criteria
• PHASE 0 DEVELOPMENT: Unable or unwilling to participate in the recorded sessions
• PHASE 0 PILOT TESTING: Inability to attend and participate in MBI due to medical or psychological hardship
• PHASE 0 PILOT TESTING: Inability to speak, read and understand English
• PHASE 1: Inability to attend and participate in MBI due to medical or psychological hardship
• PHASE 1: Inability to speak, read and understand English
• PHASE 1: Participated in phase 0 of the study
• PHASE 2: Inability to attend and participate in MBI due to medical or psychological hardship
• PHASE 2: Inability to speak, read and understand English
• PHASE 2: Participated in phase 0 or phase 1 of the study

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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115 participants in 4 patient groups

Group I (MBSR)

Experimental group

Description:

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

Treatment:

Other: Questionnaire Administration

Other: Health Promotion

Group II (control)

Active Comparator group

Description:

Patients receive usual care on study.

Treatment:

Other: Best Practice

Other: Questionnaire Administration

Phase 0 (intervention development, pilot testing)

Experimental group

Description:

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.

Treatment:

Other: Interview

Other: Questionnaire Administration

Other: Health Promotion

Other: Discussion

Phase 1 (MBSR)

Experimental group

Description:

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.

Treatment:

Other: Questionnaire Administration

Other: Health Promotion