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

NCT06767475 | Enrolling By Invitation

• 3 other identifiers: MC240901NCI-2024-1049024-006322
• Study Type: interventional
• Target: 115
• Locations: 1 country
• Sites: 1

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.

Conditions

Hematopoietic and Lymphatic System Neoplasm; Malignant Solid Neoplasm

Outcome Measures

Primary Outcomes (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

  Up to 3 months

Secondary Outcomes (5)

• Quality of life (QOL)

  Up to 3 months

• Level of resilience - CD-RISC

  Up to 3 months

• Level of resilience - RSA

  Up to 3 months

• Personal spirituality and closeness with God

  Up to 3 months

• Overall assessment of the MBI and perception of MBI value

  3 months

Study Arms (4)

Group I (MBSR)

EXPERIMENTAL

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: Health Promotion; Other: Questionnaire Administration

Group II (control)

ACTIVE COMPARATOR

Patients receive usual care on study.

Other: Best Practice; Other: Questionnaire Administration

Phase 0 (intervention development, pilot testing)

EXPERIMENTAL

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; Other: Health Promotion; Other: Interview; Other: Questionnaire Administration

Phase 1 (MBSR)

EXPERIMENTAL

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: Health Promotion; Other: Questionnaire Administration

Interventions

Best Practice OTHER

Receive usual care

Also known as: standard of care, standard therapy

Group II (control)

Discussion OTHER

Attend a focus group

Also known as: Discuss

Phase 0 (intervention development, pilot testing)

Health Promotion OTHER

Participate in group discussion with exercises and activities

Also known as: Health Promotion (Salutogenesis), Health Promotion and Wellness, Mindfulness Health Promotion, Salutogenesis

Group I (MBSR); Phase 0 (intervention development, pilot testing); Phase 1 (MBSR)

Interview OTHER

Attend a one-on-one interview

Phase 0 (intervention development, pilot testing)

Questionnaire Administration OTHER

Ancillary studies

Group I (MBSR); Group II (control); Phase 0 (intervention development, pilot testing); Phase 1 (MBSR)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Florida

Jacksonville, Florida, 32224-9980, United States

Location

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Interventions

Practice Guidelines as Topic; Standard of Care; Health Promotion; Interviews as Topic

Intervention Hierarchy (Ancestors)

Guidelines as Topic; Quality Assurance, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation; Quality Indicators, Health Care; Health Education; Preventive Health Services; Health Services; Health Care Facilities Workforce and Services; Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Public Health; Environment and Public Health

Study Officials

• Floyd B. Willis, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 2, 2025
• First Posted: January 10, 2025
• Study Start: December 31, 2024
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: May 11, 2025

Record last verified: 2025-05

Locations

US (1)