Together Stronger: A Family-centered Lifestyle Intervention for Black Prostate Cancer Survivors and Their Caregivers

NCT ID: NCT07164456

Last Updated: 2025-09-10

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 648 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-02-14
• Study Completion Date: 2033-06-30

Brief Summary

To establish the efficacy of the family-centered intervention in improving healthy lifestyle behaviors (MVPA and overall diet quality), as well as physical functioning, QoL, and family health climate, compared to survivor-only and control groups.

Detailed Description

Primary Objectives

• Determine the extent to which MVPA and overall diet quality have improved in Black PCa survivors and their caregivers in the family-centered intervention group, compared to those in the survivor-only and control groups at post-intervention.

Secondary Objectives

• Determine the extent to which, compared to those in the survivor-only and control groups, both survivors and caregivers in the family-centered group maintain the MVPA and high diet quality at the 6-month follow-up, and experience improved 6MWT, QoL, and family health climate at both post-intervention and 6-month follow-up.
• Identify mediators and moderators of the family-centered intervention.

Conditions

Family Centered; Black Ethnicity; Prostate Cancer Survivors

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Family-centered intervention

Includes a nutrition education session, a PA education session, and 12 health-coaching calls, all conducted via Zoom or phone.

Group Type: EXPERIMENTAL

Education sessions

Intervention Type: OTHER

Remote and In person sessions

Questionnaire

Intervention Type: OTHER

Questionnaires given a 3,6,12 mouth follow ups

survivor-only intervention

Includes a nutrition education session, a PA education session, and 12 health-coaching calls, all conducted via Zoom or phone.

Group Type: EXPERIMENTAL

Education sessions

Intervention Type: OTHER

Remote and In person sessions

Questionnaire

Intervention Type: OTHER

Questionnaires given a 3,6,12 mouth follow ups

Health education control

Will focus on enhancing participants' intrinsic motivation and problem-solving skills related to improving diet quality and engaging in PA. A total of 12 sessions will be provided, with approximately 2 sessions per month

Group Type: EXPERIMENTAL

Education sessions

Intervention Type: OTHER

Remote and In person sessions

Questionnaire

Intervention Type: OTHER

Questionnaires given a 3,6,12 mouth follow ups

Interventions

Education sessions

Remote and In person sessions

Intervention Type: OTHER

Questionnaire

Questionnaires given a 3,6,12 mouth follow ups

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Are adults (≥18 years old)
• Self-identify as Black or African American;
• Were diagnosed with stage 0-III PCa; completed PCa treatment; (5) are able to be physically active, as determined by responses to the Physical Activity Readiness Questionnaire (PAR-Q); and
• Have a family caregiver willing to participate together. Individuals under active surveillance for PCa will be included.

Caregivers are eligible if they:

• Are adults (≥18 years old)
• Are able to be physically active, as determined by responses to the

Exclusion Criteria

Survivors are excluded if they:

• Have a prior history of other cancer or have metastatic cancer.
• Have planned concomitant immunotherapy, hormonal therapy, chemotherapy, or radiation therapy during the study period.
• Meet physical activity recommendations (i.e., 150 min of moderate intensity physical activity per week); and (4) are currently participating in a lifestyle or weight management program.

Caregivers are excluded if they:

• Have serious medical conditions (e.g., cancer, congestive heart failure, stroke, and dementia)
• Are currently participating in a lifestyle or weight management program.

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

M.D. Anderson Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Dalnim Cho, MD

Role: PRINCIPAL_INVESTIGATOR

MD Andersson Cancer Center

Locations

MD Anderson Cancer Center

Houston, Texas, United States

Countries

United States

Central Contacts

Dalnim Cho, MD

Role: CONTACT

dcho1@mdanderson.org

713-745-8476

Facility Contacts

Dalnim Cho, MD

Role: primary

dcho1@mdanderson.org

713-745-8476

Related Links

http://www.mdanderson.org

MD Anderson Cancer Center

Other Identifiers

NCI-2025-06570

Identifier Type: OTHER

Identifier Source: secondary_id

2025-0868

Identifier Type: -

Identifier Source: org_study_id