Clinical trial NCT06767475: Mindfulness-Based Stress Reduction to Improve Well-being in Black Adult Cancer Survivors, Community Faith-based Mindfulness Ministry
Official title: Effectiveness of Mindfulness-Based Intervention on Patient Reported Outcomes of Black Adult Cancer Survivors: A Community Faith-based Mindfulness Ministry (ComFaMM) Trial
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Hematopoietic and Lymphatic System Neoplasm
Malignant Solid Neoplasm
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2025-01-10
Enrollment: 115
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: SUPPORTIVE_CARE

Brief 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. 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Spiritual well-being
timeFrame: Up to 3 months
Secondary outcomes:
measure: Quality of life (QOL)
timeFrame: Up to 3 months
measure: Level of resilience - CD-RISC
timeFrame: Up to 3 months
measure: Level of resilience - RSA
timeFrame: Up to 3 months
measure: Personal spirituality and closeness with God
timeFrame: Up to 3 months
measure: Overall assessment of the MBI and perception of MBI value
timeFrame: 3 months
Other outcomes:
Locations:
city: Jacksonville
country: United States
facility: Mayo Clinic in Florida
state: Florida
Study officials:
affiliation: Mayo Clinic
name: Floyd B. Willis, MD
role: PRINCIPAL_INVESTIGATOR
References: