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Hematopoietic and Lymphatic System NeoplasmComFaMMNCT06767475

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

A study testing Educational Intervention, Discussion and Mindfulness Relaxation in people with Hematopoietic and Lymphatic System Neoplasm and Malignant Solid Neoplasm, run by Mayo Clinic at 1 site in United States.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
What is being tested?
Educational Intervention, Discussion and Mindfulness Relaxation
Could I receive a placebo?
No, everyone receives an active treatment
How many people
65 participants
Where
1 siteUnited States
Study dates
31 Dec 2024to 31 Dec 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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
Show all 20Show fewer
  • 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

Who cannot join

  • 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
Show all 10Show fewer
  • 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 locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

United States1 site

  • Mayo Clinic in Florida

    Jacksonville, Florida, 32224-9980

Other trials in United States

About this study

Official title: 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.

Read the detailed description

PRIMARY OBJECTIVES:

  1. 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.

Being tested
Educational Intervention, Discussion, Mindfulness Relaxation, Interview, Questionnaire Administration

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Educational InterventionOther

    Also called Education for Intervention, Intervention by Education, Intervention through Education, Intervention, Educational

    Receive education resource handouts

  • DiscussionOther

    Also called Discuss

    Attend a focus group

  • Mindfulness RelaxationBehavioural

    Also called MBSR, Mindful Meditation, Mindfulness Meditation, Mindfulness-Based Stress Reduction (MBSR)

    Complete silent mindfulness retreat intervention

  • InterviewOther

    Attend a one-on-one interview

  • Questionnaire AdministrationOther

    Complete study-related questionnaires

Study groups in NCT06767475
Study groupRoleWhat they receive
Phase 0 (intervention development, pilot testing)ExperimentalINTERVENTION 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.
Receives: Other: Discussion; Other: Interview; Other: Questionnaire Administration
Phase 1 (MBSR)ExperimentalPatients 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.
Receives: Other: Educational Intervention; Behavioral: Mindfulness Relaxation; Other: Questionnaire Administration

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

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

Secondary outcomes (4)

  1. 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.

    Measured: Pre-MBI, Post-MBI, 3 months, 6months

  2. 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.

    Measured: Pre-MBI, Post-MBI, 3 months, 6months

  3. 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.

    Measured: Pre-MBI, Post-MBI, 3 months, 6months

  4. 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.

    Measured: Post-MBI, 3 months, 6months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Jan 2025
  2. Study start31 Dec 2024
  3. Primary completion31 Dec 2028 (estimated)
  4. Study completion31 Dec 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
65 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06767475
Sponsor's protocol ID
MC240901
Other IDs
24-006322
Acronym
ComFaMM
Status last verified
Jul 2026
First submitted
2 Jan 2025
Last updated
21 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Educational Intervention, Discussion and Mindfulness Relaxation in people with Hematopoietic and Lymphatic System Neoplasm and Malignant Solid Neoplasm, run by Mayo Clinic at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 20 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: enrolling by invitation, as of the sponsor's last update on 21 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Spiritual well-being (time frame: Pre-MBI, Post-MBI (immediately after MBI), 3 months, 6months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06767475.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2026.

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