Family-Centered Lifestyle Intervention for Prostate Cancer Survivors

Overseen By Dalnim Cho, MD

Age: 18+

Sex: Male

Trial Phase: Academic

Sponsor: M.D. Anderson Cancer Center

Must not be taking: Immunotherapy, Hormonal therapy

Disqualifiers: Other cancer, Metastatic cancer, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 12

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether a lifestyle program called "Together Stronger," which includes family support, can help prostate cancer survivors improve health habits, such as exercising more and eating better. It compares three groups: one with just survivors, one with survivors and their family caregivers, and one focused on general health education. The trial seeks prostate cancer survivors who identify as Black or African American, have completed treatment, and have a family member willing to participate. Participants should not currently meet exercise goals or be part of another lifestyle program. As an unphased trial, this study offers a unique opportunity for participants to contribute to research that could enhance health outcomes for prostate cancer survivors.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. However, it does mention that participants should not have planned treatments like immunotherapy, hormonal therapy, chemotherapy, or radiation therapy during the study.

What prior data suggests that the "Together Stronger" intervention is safe?

Earlier studies have shown promise for the "Together Stronger" program in supporting prostate cancer survivors. Research indicates it improves diet and physical activity with family support. Participants have reported better diet quality and physical fitness without negative effects. This approach has been well-received, with no major safety concerns. Although not a medication or surgery, the program involves lifestyle changes, which generally carry a low risk of harm. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the "Together Stronger" interventions because they focus on lifestyle changes tailored for prostate cancer survivors, which is quite different from the typical medical treatments like surgery, radiation, or hormone therapy. These interventions emphasize family involvement and personal motivation, offering a unique approach to improving survivors' health through nutrition and physical activity education, along with health-coaching sessions. By utilizing virtual platforms like Zoom and phone calls, the interventions are accessible and convenient, potentially enhancing adherence and outcomes. This holistic, family-centered approach aims to empower survivors and their families to make sustainable lifestyle changes, which could improve quality of life and health beyond traditional treatment methods.

What evidence suggests that this trial's treatments could be effective for prostate cancer survivors?

Research has shown that involving family in lifestyle changes can benefit prostate cancer survivors. In this trial, participants will join different treatment arms, including a family-centered intervention. One study found that family-focused approaches improve mental well-being and communication between patients and their families. This method also promotes healthier habits, such as improved exercise and diet, which are important for overall health. Some studies suggest these healthy habits might help prevent other health problems, like heart disease. Overall, evidence supports the benefits of including family in lifestyle changes for prostate cancer survivors. ^{1 3 6 7 8}

Who Is on the Research Team?

Dalnim Cho, MD

Principal Investigator

MD Andersson Cancer Center

Are You a Good Fit for This Trial?

This trial is for Black prostate cancer survivors who have a caregiver willing to participate. It's designed to see if involving the family can help improve lifestyle habits, physical function, and quality of life compared to just focusing on the survivor or doing nothing.

Inclusion Criteria

Survivors are eligible if they self-identify as Black or African American

I am 18 years old or older.

I had prostate cancer up to stage III, finished treatment, can be active, and have a willing family caregiver.

Exclusion Criteria

I have not had any other type of cancer or metastatic cancer before.

I am not planning to receive any other cancer treatments like immunotherapy or chemotherapy during the study.

I do not meet the recommended physical activity levels and am not in a lifestyle or weight management program.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants receive a family-centered lifestyle intervention including nutrition and PA education sessions, and 12 health-coaching calls

6 months

12 sessions (virtual)

Follow-up

Participants are monitored for maintenance of MVPA and diet quality, and improvements in 6MWT, QoL, and family health climate

6 months

What Are the Treatments Tested in This Trial?

Interventions

• Together Stronger

Trial Overview

The study tests a program where families get education sessions aimed at promoting healthier living and are asked to fill out questionnaires. The goal is to see if this 'family-centered' approach is better than when only the survivor participates or no intervention is given.

How Is the Trial Designed?

Group I: survivor-only intervention Experimental Treatment 2 Interventions

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

Group II: Health education control Experimental Treatment 2 Interventions

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 III: Family-centered intervention Experimental Treatment 2 Interventions

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

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3,107

Recruited

1,813,000+

Citations

1.

withpower.com

withpower.com/trial/phase-prostate-cancer-survivors-1-2026-32a69

Family-Centered Lifestyle Intervention for Prostate Cancer ...

... Together Stronger will have tolerable side effects & efficacy for patients with Family therapy, Melasma and Prostate cancer survivors. Learn more about the

2.

smartpatients.com

smartpatients.com/trials/NCT07164456

A Family-centered Lifestyle Intervention for Black Prostate ...

To establish the efficacy of the family-centered intervention in improving healthy lifestyle behaviors (MVPA and overall diet quality), as well as physical ...

3.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10528560/

Assessing the Efficacy of a 28-Day Comprehensive Online ...

The findings consistently demonstrated significant improvements in psychological aspects among patients receiving these interventions compared ...

4.

ebccp.cancercontrol.cancer.gov

ebccp.cancercontrol.cancer.gov/programDetails.do?programId=102766

Family-based Interventions (The FOCUS Program) for Men ...

The study showed decreased uncertainty and increased communication between patients and their spouses/partners. Program Highlights. Purpose: ...

5.

jamanetwork.com

jamanetwork.com/journals/jamanetworkopen/fullarticle/2839379

Adherence to American Cancer Society Guideline and ...

Some studies suggest that PCSM and CVDM may be preventable through healthy lifestyle behaviors, underscoring the need to investigate modifiable ...

6.

ctv.veeva.com

ctv.veeva.com/study/together-stronger-a-family-centered-lifestyle-intervention-for-black-prostate-cancer-survivors-and

A Family-centered Lifestyle Intervention for Black Prostate ...

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

7.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/39945428/

Couple-based lifestyle intervention for minority prostate ...

Intervention group survivors showed meaningful improvements in diet quality from T1 to T2 (+ 6.56) and a clinically important increase in ...

8.

researchgate.net

researchgate.net/publication/388965540_Couple-based_lifestyle_intervention_for_minority_prostate_cancer_survivors_a_randomized_feasibility_trial

Couple-based lifestyle intervention for minority prostate ...

Intervention group survivors showed meaningful improvements in diet quality from T1 to T2 (+ 6.56) and a clinically important increase in ...