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

M.D. Anderson Cancer Center

Status: Begins enrollment in 2 months

Conditions: Family Centered; Black Ethnicity; Prostate Cancer Survivors

Treatments: Other: Questionnaire; Other: Education sessions

Study type: Interventional

Funder types: Other

Identifiers

NCT07164456

NCI-2025-06570 (Other Identifier)

2025-0868

Details and patient eligibility

About

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.

Full 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.

Enrollment: 648 estimated patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Eligibility Criteria

Survivors are eligible if they

• 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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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648 participants in 3 patient groups

Family-centered intervention

Experimental group

Description:

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

Treatment:

Other: Education sessions

Other: Questionnaire

survivor-only intervention

Experimental group

Description:

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

Treatment:

Other: Education sessions

Other: Questionnaire

Health education control

Experimental group

Description:

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

Treatment:

Other: Education sessions

Other: Questionnaire