Recruiting

Family-Centered Intervention

Sponsor:

M.D. Anderson Cancer Center

Code:

NCT07164456

Conditions

Family Centered

Black Ethnicity

Prostate Cancer Survivors

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Education sessions

Questionnaire

Study Details

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.

Conditions

Family Centered

Black Ethnicity

Prostate Cancer Survivors

Study ID

NCT07164456

Start date

Jan 13, 2026

Status verified date

Mar, 2026

Completion date

Jun 30, 2033

Anticipated

Primary completion date

Jun 30, 2031

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

648 participants

Anticipated

Allocation

Randomized

Intervention Model

Single group

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: Family-centered intervention

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

experimental: survivor-only intervention

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

experimental: 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

Interventions

Education sessions

Remote and In person sessions

Questionnaire

Questionnaires given a 3,6,12 mouth follow ups

Primary outcome measure

  • Physical Activity Readiness Questionnaire [ Time Frame: Through study completion; an average of 1 year ]

Central Contacts and Locations

Central contacts

Dalnim Cho, MD

713-745-8476dcho1@mdanderson.org

Locations

MD Anderson Cancer Center

Recruiting

Houston, Texas, United States, 77030

Contacts

Dalnim Cho, MD

713-745-8476dcho1@mdanderson.org

Principal Investigator:

Dalnim Cho, MD

More Information

Sponsor

M.D. Anderson Cancer Center

Last update posted

Mar 9, 2026

Last verified

Mar, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by M.D. Anderson Cancer Center on 2026-03-09.