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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to evaluate how effectively a lifestyle program helps Black or African American men who have survived prostate cancer improve body composition by decreasing fat and increasing muscle. Participants will join a four-month program with twice-weekly sessions focused on nutrition and exercise, following guidelines from the American Cancer Society. The trial seeks men who completed prostate cancer treatment at least six months ago, are not meeting exercise or nutrition guidelines, and can engage in moderate physical activities. As an unphased trial, this study offers participants a unique opportunity to enhance their health and well-being through a structured lifestyle program.

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 prior data suggests that this lifestyle program is safe for prostate cancer survivors?

Research has shown that lifestyle programs, like the one in this study, are generally safe and easy to follow. Previous studies found that home-based diet and exercise plans can help older cancer survivors improve their habits without causing major problems. Participants can expect a positive and safe experience.

These programs often include learning about lifestyle changes and participating in supervised exercise sessions. The goal is to help participants get healthier through better eating and physical activity. So far, no serious issues have been reported from these types of programs.

In summary, the lifestyle program being tested is known for its safety. It is designed to be supportive and helpful, making it a promising choice for those considering joining the trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Lifestyle Program for Prostate Cancer Survivors because it focuses on empowering patients through education and physical activity, rather than relying solely on medical or surgical treatments like hormone therapy or surgery. This program is unique because it combines lifestyle change education with supervised exercise sessions, offering a holistic approach to improving health. By targeting lifestyle factors, the program aims to enhance overall well-being and potentially improve outcomes for prostate cancer survivors. Additionally, the use of text message support and personalized informational binders provides ongoing motivation and guidance, which is a fresh approach compared to existing treatments.

What evidence suggests that this lifestyle program is effective for prostate cancer survivors?

This trial will compare an Immediate Guided Lifestyle Program Intervention with a Waitlist Control for prostate cancer survivors. Research has shown that lifestyle programs like Men Moving Forward (MMF) can benefit cancer survivors. Studies have found that diet and exercise plans improve the habits of older cancer survivors, leading to healthier eating, more regular exercise, and potentially better body health, such as reduced body fat and increased muscle. These programs can enhance quality of life and assist with weight management, which is important for prostate cancer survivors. While specific results for MMF and prostate cancer survivors are still under investigation, similar programs have demonstrated positive health benefits. ^{1 2 4 6 7}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

Citations

1. withpower.com withpower.com/trial/phase-prostatic-neoplasms-5-2019-e0d32

Lifestyle Program for Prostate Cancer Survivors (MMF Trial) This study will examine the efficacy of Men Moving Forward (MMF), a four-month community-based lifestyle intervention designed for AA PC survivors.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC1532928/

Lifestyle Intervention Development Study to Improve ... Conclusion. These findings suggest that home-based diet and exercise interventions hold promise in improving lifestyle behaviors among older cancer survivors, ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7685923/

Web-Based Lifestyle Interventions for Prostate Cancer ... In this report, we aim to explore the insights of prostate cancer survivors who engaged with a web-based lifestyle intervention and to provide ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S0022316622090447

Lifestyle Interventions in Cancer Survivors Lifestyle factors, such as a healthy diet, regular exercise, and smoking cessation may prevent these conditions and improve survivors' quality of life.

5. clinicaltrials.gov clinicaltrials.gov/study/NCT07093177

Multimodal Telerehabilitation of Rural Patients With ... This study is a pilot study to assess usability, acceptability, and exercise adherence in 12-week multimodal telerehabilitation in patients receiving ADT with ...

6. cancer.gov cancer.gov/research/participate/clinical-trials-search/v?id=NCI-2023-03141

Internet-Based Lifestyle Intervention to Eradicate Obese ... Androgen deprivation therapy increases the risk of frailty, weight gain and obesity in prostate cancer survivors. The combination of frailty and obesity can ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3641190/

LONG-TERM PHYSICAL ACTIVITY OUTCOMES OF HOME ... This study provides evidence that mailed-print exercise interventions result in significant and sustainable improvements in MVPA among newly-diagnosed cancer ...