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: Discussion; Other: Interview; Other: Questionnaire Administration; Other: Educational Intervention; Behavioral: Mindfulness Relaxation

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) III. To implement an overnight silent mindfulness retreat intervention that incorporates faith based cultural adaptations tailored for Black participants. (Phase I)

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 an overnight silent mindfulness retreat intervention, over 31 hours, with faith-based cultural adaptation emphasizing resilience and cultural relevant spiritual framing. The retreat includes sessions on different types of meditation, working with thoughts and emotions, stress, mindfulness techniques and how to integrate them, positive mind states, resiliency and resources, including educational handouts.

After completion of study intervention, patients are followed up at 3 and 6 months.

• Study Type: Interventional
• Enrollment (Estimated): 65
• 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: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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: Discussion; Attend a focus group; Other Names: Discuss; Other: Interview; Attend a one-on-one interview; Other: Questionnaire Administration; Complete study-related questionnaires
Experimental: Phase 1 (MBSR); Patients participate in an overnight silent mindfulness retreat intervention, over 31 hours, with faith-based cultural adaptation emphasizing resilience and cultural relevant spiritual framing. The retreat includes sessions on different types of meditation, working with thoughts and emotions, stress, mindfulness techniques and how to integrate them, positive mind states, resiliency and resources, including educational handouts.	Other: Questionnaire Administration; Complete study-related questionnaires; Other: Educational Intervention; Receive education resource handouts; Other Names: Education for Intervention; Intervention by Education; Intervention through Education; Intervention, Educational; Behavioral: Mindfulness Relaxation; Complete silent mindfulness retreat intervention; Other Names: MBSR; Mindfulness Meditation; Mindful Meditation; Mindfulness-Based Stress Reduction (MBSR)

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	Pre-MBI, Post-MBI (immediately after MBI), 3 months, 6months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of life (QOL) (Phase 1)	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.	Pre-MBI, Post-MBI, 3 months, 6months
Level of resilience - CD-RISC (Phase 1)	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.	Pre-MBI, Post-MBI, 3 months, 6months
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.	Pre-MBI, Post-MBI, 3 months, 6months
Overall assessment of the MBI and perception of MBI value (Phase 1)	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.	Post-MBI, 3 months, 6months

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): July 21, 2026
• Last Update Submitted That Met QC Criteria: July 17, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Health Care Quality, Access, and Evaluation; Investigative Techniques; Epidemiologic Methods; Data Collection; Health Care Evaluation Mechanisms; Quality of Health Care; Public Health; Environment and Public Health; Health Services; Health Care Facilities Workforce and Services; Child Health Services; Community Health Services; Preventive Health Services; Socioeconomic Factors; Population Characteristics; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Cognitive Behavioral Therapy; Methods; Interviews as Topic; Early Intervention, Educational; Educational Status; Mindfulness; Mindfulness-Based Stress Reduction
• Other Study ID Numbers: MC240901 (Mayo Clinic); 24-006322 (Other Identifier: Mayo Clinic Institutional Review Board)

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