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Enrolling by Invitation

NCT Number: NCT06767475

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

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.

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Key information

Conditions

Hematopoietic and Lymphatic System Neoplasm Malignant Solid Neoplasm

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Clinic in Florida

Jacksonville, Florida, 32224-9980, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Educational Intervention

Other

Receive education resource handouts

Other names: Education for Intervention, Intervention by Education, Intervention through Education, Intervention, Educational

Discussion

Other

Attend a focus group

Other names: Discuss

Mindfulness Relaxation

Behavioral

Complete silent mindfulness retreat intervention

Other names: MBSR, Mindful Meditation, Mindfulness Meditation, Mindfulness-Based Stress Reduction (MBSR)

interview

Other

Attend a one-on-one interview

Questionnaire Administration

Other

Complete study-related questionnaires

Primary outcomes

  1. Spiritual well-being

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

    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

Secondary outcomes

  1. Quality of life (QOL) (Phase 1)

    Time frame: Pre-MBI, Post-MBI, 3 months, 6months

    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.

  2. Level of resilience - CD-RISC (Phase 1)

    Time frame: Pre-MBI, Post-MBI, 3 months, 6months

    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.

  3. Level of resilience - RSA

    Time frame: Pre-MBI, Post-MBI, 3 months, 6months

    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.

  4. Overall assessment of the MBI and perception of MBI value (Phase 1)

    Time frame: Post-MBI, 3 months, 6months

    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.

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

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

Acronym: ComFaMM

Important dates

Study start
2024
Primary completion
2028
Study completion
2028
First posted
Jan 10, 2025
Registry last updated
Jul 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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