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

NCT03971591 | Active Not Recruiting DMC

• 1 other identifier: PRO00031416
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (44)

• Change in body composition

  Ratio of percent lean mass to percent adiposity as measured by DEXA. More lean mass and less adiposity is favorable.

  Change from Baseline to 4 month

• Change in body composition

  Ratio of percent lean mass to percent adiposity as measured by DEXA. More lean mass and less adiposity is favorable.

  Change from Baseline to 12 month

• Increase in intake of fruits and vegetables

  VioScreen's dietary analysis of self reported food consumption

  Change from Baseline to 4 month

• Increase in intake of fruits and vegetables

  VioScreen's dietary analysis of self reported food consumption

  Change from Baseline to 12 month

• Decrease of intake of red meat/processed meat

  VioScreen's dietary analysis of self reported food consumption

  Change from Baseline to 4 month

• Decrease of intake of red meat/processed meat

  VioScreen's dietary analysis of self reported food consumption

  Change from Baseline to 12 month

• Increase in levels of physical activity- minutes per week

  Change of ActiGraph monitored activity

  Change from Baseline to 4 month

• Increase in levels of physical activity- minutes per week

  Change of ActiGraph monitored activity

  Change from Baseline to 12 month

• Increase in levels of physical activity- #times per week

  Change of ActiGraph monitored activity

  Change from Baseline to 4 month

• Increase in levels of physical activity- #times per week

  Change of ActiGraph monitored activity

  Change from Baseline to 12 month

• Increase in resistance training- Lower extremity strength

  Isokinetic dynamometer (HUMAC Norm, Stoughton, MA).

  Change from Baseline to 4 month

• Increase in resistance training- Lower extremity strength

  Isokinetic dynamometer (HUMAC Norm, Stoughton, MA).

  Change from Baseline to 12 month

• Increase in resistance training- Handgrip strength

  Takei 5401 Hand Grip Digital Dynamometer

  Change from Baseline to 4 month

• Increase in resistance training- Handgrip strength

  Takei 5401 Hand Grip Digital Dynamometer

  Change from Baseline to 12 month

• Increase in resistance training- Strength and endurance

  30-Second Chair Stand (Sit to Stand)

  Change from Baseline to 4 month

• Increase in resistance training- Strength and endurance

  30-Second Chair Stand (Sit to Stand)

  Change from Baseline to 12 month

• Change in Quality of Life- PROMIS

  PROMIS T-score metric in which 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population. PROMIS measures physical function, depression, anxiety, fatigue, sleep disturbance, social roles, pain interference, social isolation, cognitive function, support, self-efficacy and sexual function.

  Change from Baseline to 4 month

• Change in Quality of Life-PROMIS

  PROMIS T-score metric in which 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population. PROMIS measures physical function, depression, anxiety, fatigue, sleep disturbance, social roles, pain interference, social isolation, cognitive function, support, self-efficacy and sexual function.

  Change from Baseline to 4 month

• Change in Urban life stress inventory- Crisys

  Measure change of mean in positive/negative/neutral and resolved/ongoing

  Change from Baseline to 4 month

• Change in Urban life stress inventory-Crisys

  Measure change of mean in positive/negative/neutral and resolved/ongoing

  Change from Baseline to 12 month

• Changes in Blood Pressure

  Participants blood pressure will be measured using a digital, automated unit

  Change from Baseline to 4 month

• Change in Blood Pressure

  Participants blood pressure will be measured using a digital, automated unit

  Change from Baseline to 12 month

• Change in Biomarkers- Hemoglobin

  Hemoglobin blood tests measured by Wisconsin Diagnostic Laboratory

  Change from Baseline to 4 month

• Change in Biomarkers-Hemoglobin

  Hemoglobin blood tests measured by Wisconsin Diagnostic Laboratory

  Change from Baseline to 12 month

• Change in Biomarkers- A1C

  A1C blood tests measured by Wisconsin Diagnostic Laboratory

  Change from Baseline to 4 month

• Change in Biomarkers- A1C

  A1C blood tests measured by Wisconsin Diagnostic Laboratory

  Change from Baseline to 12 month

• Change in Biomarkers- Hormones-Testosterone

  Testosterone blood test measured by Wisconsin Diagnostic Laboratory

  Change from Baseline to 4 month

• Change in Biomarkers- Hormones-Testosterone

  Testosterone blood test measured by Wisconsin Diagnostic Laboratory

  Change from Baseline to 12 month

• Change in Biomarkers- Hormones- Estradiol

  Estradiol blood test measured by Wisconsin Diagnostic Laboratory

  Change from Baseline to 4 month

• Change in Biomarkers- Hormones- Estradiol

  Estradiol blood test measured by Wisconsin Diagnostic Laboratory

  Change from Baseline to 12 month

• Change in Biomarkers- Hormones- SHBG

  SHBG blood test measured by Wisconsin Diagnostic Laboratory

  Change from Baseline to 4 month

• Change in Biomarkers- Hormones- SHBG

  SHBG blood test measured by Wisconsin Diagnostic Laboratory

  Change from Baseline to 12 month

• Change in Biomarkers-Adipokines- Leptin

  Leptin blood test measured by Wisconsin Diagnostic Laboratory

  Change from Baseline to 4 month

• Change in Biomarkers-Adipokines- Leptin

  Leptin,blood test measured by Wisconsin Diagnostic Laboratory

  Change from Baseline to 12 month

• Change in Biomarkers-Adipokines-Adiponectin

  Adiponectin blood test measured by Wisconsin Diagnostic Laboratory

  Change from Baseline to 4 month

• Change in Biomarkers-Adipokines-Adiponectin

  Adiponectin blood test measured by Wisconsin Diagnostic Laboratory

  Change from Baseline to 12 month

• Change in Biomarkers-Inflammation- IL-6

  IL-6 blood test measured by Wisconsin Diagnostic Laboratory

  Change from Baseline to 4 month

• Change in Biomarkers-Inflammation- IL-6

  IL-6 blood test measured by Wisconsin Diagnostic Laboratory Wisconsin

  Change from Baseline to 12 month

• Change in Biomarkers-Inflammation-TNFα

  TNFα blood test measured by Wisconsin Diagnostic Laboratory

  Change from Baseline to 4 month

• Change in Biomarkers-Inflammation-TNFα

  TNFα blood test measured by Wisconsin Diagnostic Laboratory

  Change from Baseline to 12 month

• Change in Biomarkers-Insulin Resistance-C-Peptide

  C-Peptide blood test measured by Wisconsin Diagnostic Laboratory

  Change from Baseline to 4 month

• Change in Biomarkers-Insulin Resistance- C-Peptide

  C-Peptide blood test measured by Wisconsin Diagnostic Laboratory

  Change from Baseline to 12 month

• Change in Biomarkers-Insulin Resistance-IGF-1

  IGF-1 blood test measured by Wisconsin Diagnostic Laboratory

  Change from Baseline to 4 month

• Change in Biomarkers Insulin Resistance-IGF-1

  IGF-1 blood test measured by Wisconsin Diagnostic Laboratory

  Change from Baseline to 12 month

Study Arms (2)

Immediate Lifestyle program

EXPERIMENTAL

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.

Behavioral: Immediate Guided Lifestyle Program Intervention

Waitlist Control

OTHER

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.

Behavioral: Immediate Guided Lifestyle Program Intervention

Interventions

Immediate Guided Lifestyle Program Intervention BEHAVIORAL

The Guided Lifestyle Program will receive sessions that meet twice weekly and 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.

Immediate Lifestyle program; Waitlist Control

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Male Prostate Cancer study participants
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

Sponsors & Collaborators

• Marquette University: collaborator
• University of Illinois at Chicago: collaborator
• Medical College of Wisconsin: lead
• Loyola University Chicago: collaborator

Study Sites (1)

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

Related Publications (1)

• Awoyinka I, Sheean P, Papanek P, Flynn KE, Bylow K, Kilari D, Gann P, Banerjee A, Stolley M. Study design and methodologies for the men moving forward lifestyle intervention trial with black prostate cancer survivors. Contemp Clin Trials. 2026 Feb;161:108205. doi: 10.1016/j.cct.2025.108205. Epub 2025 Dec 24.

  PMID: 41453520 DERIVED

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Director for Cancer Prevention and Control

Model Details: Participants will be randomized to either a guided or self-guided lifestyle intervention

Study Record Dates

• First Submitted: May 9, 2019
• First Posted: June 3, 2019
• Study Start: June 1, 2019
• Primary Completion (Estimated): May 30, 2026
• Study Completion (Estimated): May 30, 2026
• Last Updated: January 12, 2026

Record last verified: 2025-09

Locations

US (1)