Men Moving Forward: A Lifestyle Program for African-American Prostate Cancer Survivors (MMF)

Medical College of Wisconsin

Status: Active, not recruiting

Conditions: Prostate Cancer

Treatments: Behavioral: Immediate Guided Lifestyle Program Intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT03971591

PRO00031416

Details and patient eligibility

About

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).

Full description

Aim 1. To examine the efficacy of the Men Moving Forward guided intervention, as compared to a self-guided control intervention, in producing significant post-intervention changes in body composition in 200 AA PC survivors.

Hypothesis: Men randomized to the guided arm will exhibit significant post-intervention decreases in adiposity and increases in lean body mass compared to men randomized to the control arm.

Aim 2. To investigate the effects of participation in the Men Moving Forward guided intervention on health behaviors and quality of life outcomes.

Hypothesis: Men in the guided program will exhibit increased intake of fruits and vegetables and decreased intake of red meat/processed meat, greater levels of physical activity (minutes per week and #times/wk resistance training) and improved quality of life (targeting physical function, social isolation, sexual functioning) compared to men in the control arm.

Aim 3. To explore the effects of the intervention program on blood pressure, blood lipids, fasting glucose, and biomarkers associated with comorbidities and carcinogenesis (i.e adiponectin, leptin, C-peptide, IGF-1, IGFBP-3, C-Reactive Protein, estradiol, testosterone and sex hormone binding globulin)

Hypothesis: Men in the guided arm will exhibit greater improvements in biomarkers associated with chronic disease and carcionogenesis compared to men in the self-guided control arm.

Men Moving Forward supports PC survivors in adopting physical activity and eating patterns that will improve their body composition, bolster QOL and reduce risk for comorbidities and, potentially, PC recurrence.

Enrollment: 200 estimated patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age 18 years and older
• Self-identify as Black or African American
• Diagnosed with non-metastatic Prostate Cancer (cancer that has NOT spread elsewhere in the body)
• Completed all treatments (including Androgen Deprivation Therapy) at least six months prior to enrollment
• BMI > 25 kg/m2
• Able to participate in moderate physical activity as assessed by healthcare provider
• Exercise less than the ACS recommended guideline of 150 min/week or 30 min/day.
• Fruit and vegetable consumption is less than 5 servings each day.
• Lift Weights or engage in strength training less than twice a week.
• Can walk continuously for 5 minutes without stopping because of pain or shortness of breath.
• Have access to a mobile phone
• Approval from Primary Care Provider/Medical Oncologist
• Available to attend intervention

Exclusion criteria

• • Does not meet the Inclusion Criteria

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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200 participants in 2 patient groups

Immediate Lifestyle program

Experimental group

Description:

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.

Treatment:

Behavioral: Immediate Guided Lifestyle Program Intervention

Waitlist Control

Other group

Description:

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.

Treatment:

Behavioral: Immediate Guided Lifestyle Program Intervention