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

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).

Study Overview

• Status: Recruiting
• Conditions: Prostate Cancer
• Intervention / Treatment: Behavioral: Immediate Guided Lifestyle Program Intervention

Detailed 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.

• Study Type: Interventional
• Enrollment (Estimated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jo Bergholte, MLIS; Phone Number: 414-805-6990; Email: jbergholte@mcw.edu
• Study Contact Backup: Name: Kathleen Jensik, MSW; Phone Number: 414-955-2114; Email: kjensik@mcw.edu

Study Locations

• United States
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53226
      • Recruiting
      • Medical College of Wisconsin
      • Principal Investigator: Melinda Stolley, PhD
      • Contact: Kathleen OConnell, PhD; Phone Number: 414-955-2114; Email: kaoconnell@mcw.edu
      • Contact: Margaret Tovar; Phone Number: 414-955-2114; Email: mtovar@mcw.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Immediate Lifestyle program; 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; 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.
Other: Waitlist Control; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Medical College of Wisconsin
• Collaborators: University of Illinois at Chicago; Loyola University Chicago; Marquette University

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2019
• Primary Completion (Estimated): June 30, 2024
• Study Completion (Estimated): June 30, 2024

Study Registration Dates

• First Submitted: May 9, 2019
• First Submitted That Met QC Criteria: May 31, 2019
• First Posted (Actual): June 3, 2019

Study Record Updates

• Last Update Posted (Actual): October 19, 2023
• Last Update Submitted That Met QC Criteria: October 17, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Urogenital Diseases; Male Urogenital Diseases; Genital Diseases, Male; Genital Diseases; Prostatic Neoplasms
• Other Study ID Numbers: PRO00031416

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No