Lifestyle Program for Prostate Cancer Survivors

(MMF Trial)

Overseen By Kathleen Jensik, MSW

Age: 18+

Sex: Male

Trial Phase: Academic

Sponsor: Medical College of Wisconsin

Disqualifiers: Non-black, Metastatic cancer, others

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

Compensation: Varies

Number of Visits: 32

Duration: 16 weeks

200 Participants Needed

Trial Summary

What is the purpose of this trial?

This study will examine the efficacy of Men Moving Forward (MMF), a four-month community-based lifestyle intervention designed for AA PC survivors. MMF is rooted in the evidence-based Moving Forward lifestyle intervention developed with and for AA breast cancer survivors. This intervention was adapted in collaboration with AA PC survivors. It will offer twice weekly sessions aimed at supporting adherence to the ACS nutrition and physical activity guidelines to promote improved body composition (i.e., decreased adiposity, increased lean mass).

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with your healthcare provider.

What data supports the effectiveness of the treatment Guided Lifestyle Program Intervention for prostate cancer survivors?

Research suggests that adopting healthier lifestyle habits, such as improved diet and physical activity, can enhance the quality of life and health outcomes for prostate cancer survivors. These changes may also potentially improve their prognosis, making lifestyle programs a promising approach for aftercare. ^{1 2 3 4 5}

Is the Lifestyle Program for Prostate Cancer Survivors safe for participants?

The available research does not specifically address safety concerns, but lifestyle programs focusing on diet and physical activity are generally considered safe and beneficial for improving quality of life and health outcomes in prostate cancer survivors. ^{2 3 4 6 7}

How is the Guided Lifestyle Program Intervention different from other treatments for prostate cancer survivors?

The Guided Lifestyle Program Intervention is unique because it focuses on improving diet and physical activity to enhance the quality of life and health outcomes for prostate cancer survivors, rather than relying on medication or surgery. This approach is designed to be sustainable and integrated into routine practice, offering a holistic way to manage survivorship. ^{2 3 4 5 8}

Eligibility Criteria

This trial is for African-American men who are overweight, have had non-metastatic prostate cancer, and finished treatment at least six months ago. They should be able to do moderate exercise but currently don't meet the recommended physical activity levels or fruit and vegetable intake. Participants need a mobile phone, approval from their doctor, and must commit to attending the program.

Inclusion Criteria

My doctor says I can do moderate exercise.

You identify yourself as a Black or African American.

You don't exercise your muscles by lifting weights or doing strength training at least twice a week.

Exclusion Criteria

Does not meet the Inclusion Criteria

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants engage in the Men Moving Forward guided intervention, with twice weekly sessions focusing on lifestyle change education and supervised exercise

16 weeks

32 visits (in-person)

Follow-up

Participants are monitored for changes in biomarkers, physical activity, and quality of life outcomes

12 months

Treatment Details

Interventions

• Guided Lifestyle Program Intervention
• Immediate Guided Lifestyle Program Intervention

Trial Overview The study tests 'Men Moving Forward', a lifestyle intervention designed for African-American prostate cancer survivors. It includes twice-weekly sessions over four months that encourage following nutrition and physical activity guidelines to improve body composition.

Participant Groups

Group I: Waitlist Control Experimental Treatment 1 Intervention

In the waitlist control arm, the men will not receive any intervention for 16-weeks. After the 16-week assessment, men randomized to this arm will crossover to the intervention arm.

Group II: Immediate Lifestyle program Experimental Treatment 1 Intervention

The Intervention will be conducted in cohorts of 15-20. We anticipate there will be 5-6 cohorts over the course of the study. Men assigned to the Guided Lifestyle Program will participate in twice weekly sessions - the first weekly session will be 120 minutes in length with the first hour addressing lifestyle change education and strategies, the second hour will be supervised exercise with strength training. The second weekly session will be a one-hour supervised exercise session with strength training. Men will also receive 2-3 text messages weekly. They will also receive a participant informational binder with health and exercise information and tools as directed by ACS nutrition and physical activity guidelines.

Who Is Running the Clinical Trial?

Medical College of Wisconsin

Lead Sponsor

Trials

645

Recruited

1,180,000+

University of Illinois at Chicago

Collaborator

Trials

653

Recruited

1,574,000+

Marquette University

Collaborator

Trials

68

Recruited

202,000+

Loyola University Chicago

Collaborator

Trials

23

Recruited

13,100+

Findings from Research

A scoping review of 16 studies identified key barriers for prostate cancer survivors in making lifestyle changes, including a perceived lack of evidence for dietary guidelines, treatment side effects, and time constraints.

Facilitators for lifestyle changes included support from health professionals and family, viewing diagnosis as a motivation for change, and using lifestyle adjustments as coping strategies to manage side effects and enhance well-being.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Facilitators and barriers to participation in lifestyle modification for men with prostate cancer: A scoping review. Yannitsos, D., Murphy, RA., Pollock, P., et al.[2020]

The Community of Wellness is a Web-based intervention designed to support prostate cancer survivors in improving their physical activity and dietary habits, with a randomized controlled trial currently enrolling 200 participants to assess its feasibility and acceptability.

Preliminary results will help determine the most effective level of online support needed to promote health behavior changes in men with prostate cancer, potentially informing future scalable health interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of Increasing Levels of Web-Based Behavioral Support on Changes in Physical Activity, Diet, and Symptoms in Men With Prostate Cancer: Protocol for a Randomized Controlled Trial. Winters-Stone, KM., Kenfield, SA., Van Blarigan, EL., et al.[2020]

References

1. Germany pubmed.ncbi.nlm.nih.gov

Prostate cancer progression and mortality: a review of diet and lifestyle factors. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Feasibility, acceptability, and behavioral outcomes of a multimodal intervention for prostate cancer patients: Experience from the MARTINI lifestyle program. [2023]

3. England pubmed.ncbi.nlm.nih.gov

Facilitators and barriers to participation in lifestyle modification for men with prostate cancer: A scoping review. [2020]

4. Canada pubmed.ncbi.nlm.nih.gov

Effect of Increasing Levels of Web-Based Behavioral Support on Changes in Physical Activity, Diet, and Symptoms in Men With Prostate Cancer: Protocol for a Randomized Controlled Trial. [2020]

5. Switzerland pubmed.ncbi.nlm.nih.gov

The Problem of Underrepresentation: Black Participants in Lifestyle Trials Among Patients with Prostate Cancer. [2022]

6. England pubmed.ncbi.nlm.nih.gov

Comprehensive Lifestyle Improvement Program for Prostate Cancer (CLIPP) is associated with improvement in weight and components of metabolic syndrome in men exposed to androgen deprivation therapy for prostate cancer. [2023]

7. United States pubmed.ncbi.nlm.nih.gov

Qualitative Evaluation of a Community-Based Physical Activity and Yoga Program for Men Living With Prostate Cancer: Survivor Perspectives. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Prostate cancer survivorship care guideline: American Society of Clinical Oncology Clinical Practice Guideline endorsement. [2022]