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

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

Study Overview

• Status: Enrolling by invitation
• Conditions: Malignant Solid Neoplasm; Hematopoietic and Lymphatic System Neoplasm
• Intervention / Treatment: Other: Questionnaire Administration; Other: Best Practice; Other: Health Promotion; Other: Discussion; Other: Interview

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.

• Study Type: Interventional
• Enrollment (Estimated): 115
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Jacksonville, Florida, United States, 32224-9980
      • Mayo Clinic in Florida

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group I (MBSR); Patients participate in group discussions, exercises, and activities over no more than 8 hours for up to 3 sessions (up to 16 hours total).	Other: Questionnaire Administration; Ancillary studies; Other: Health Promotion; Participate in group discussion with exercises and activities; Other Names: Health Promotion (Salutogenesis); Health Promotion and Wellness; Mindfulness Health Promotion; Salutogenesis
Active Comparator: Group II (control); Patients receive usual care on study.	Other: Questionnaire Administration; Ancillary studies; Other: Best Practice; Receive usual care; Other Names: standard of care; standard therapy
Experimental: Phase 0 (intervention development, pilot testing); 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.	Other: Questionnaire Administration; Ancillary studies; Other: Health Promotion; Participate in group discussion with exercises and activities; Other Names: Health Promotion (Salutogenesis); Health Promotion and Wellness; Mindfulness Health Promotion; Salutogenesis; Other: Discussion; Attend a focus group; Other Names: Discuss; Other: Interview; Attend a one-on-one interview
Experimental: Phase 1 (MBSR); 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.	Other: Questionnaire Administration; Ancillary studies; Other: Health Promotion; Participate in group discussion with exercises and activities; Other Names: Health Promotion (Salutogenesis); Health Promotion and Wellness; Mindfulness Health Promotion; Salutogenesis

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Spiritual well-being	Will be measured by the change in scores on the Functional Assessment of Chronic Illness Therapy-Spiritual Well-Being Scale (FACIT-Sp-12). The FACIT-Sp-12a is a 12-item scale measuring spiritual well-being over the past 7 days. Responses are on a 5 point Likert-type scale (0=not at all; 1=a little bit, 2=somewhat; 3=quite a bit; 4=very much) with higher scores generally representing greater well-being	Up to 3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of life (QOL)	Will be evaluated using changes in health related QOL patient reported outcomes responses. The World Health Organization Quality of Life Brief Version (WHOQOL-BREF) will be used to assess spiritual, religious or personal beliefs and how these beliefs have affected QOL including positive feelings, social support, self-esteem, pain, energy, work capacity, health and social care, and leisure activities. The WHOQOL-BREF is a 26-question instrument consisting of four domains. Each individual item of the WHOQOL-BREF is scored from 1-5 on a five-point ordinal scale.	Up to 3 months
Level of resilience - CD-RISC	Will be measured by the Connor- Davidson Resilience Scale (CD-RISC). The CD-RISC is comprised of 25 items, each rated on a 5-point scale (0-4), with higher scores reflecting greater resilience.	Up to 3 months
Level of resilience - RSA	Will be measured by the Resilience Scale for Adults (RSA). The RSA examines intrapersonal and interpersonal protective factors presumed to facilitate adaptation to psychosocial adversities, as well as family and social protective factors of resilience. The RSA has 33 items; item-response ranges from one to seven; higher scores reflect higher levels of protective factors of resilience.	Up to 3 months
Personal spirituality and closeness with God	Will be measured by change in spiritual variable adapted from Daily Spiritual Experience Scale (DSES) to assess perceived closeness to a higher power (God). The DSES is a 16-item self-report measure designed to assess ordinary experiences of connection with the transcendent in daily life. Responses are on a 6-point scale (many times a day; every day; most days; some days; once in a while; never) or 4-point scale (not at all; somewhat close; very close; as close as possible).	Up to 3 months
Overall assessment of the MBI and perception of MBI value	Will be assessed using the Was It Worth It (WIWI) questionnaire to determine changes in participants view on the worthiness of the intervention. Responses to the WIWI will capture participants' subjective evaluations of the intervention's impact. WIWI is a 3-item questionnaire with yes or no responses.	3 months

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Investigators: Principal Investigator: Floyd B. Willis, MD, Mayo Clinic

Publications and helpful links

Helpful Links

• Mayo Clinic Clinical Trials

Study record dates

Study Major Dates

• Study Start (Actual): December 31, 2024
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2028

Study Registration Dates

• First Submitted: January 2, 2025
• First Submitted That Met QC Criteria: January 8, 2025
• First Posted (Actual): January 10, 2025

Study Record Updates

• Last Update Posted (Actual): May 11, 2025
• Last Update Submitted That Met QC Criteria: May 7, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: MC240901 (Other Identifier: Mayo Clinic); 24-006322 (Other Identifier: Mayo Clinic Institutional Review Board); NCI-2024-10490 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No