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

• ClinicalTrials.gov Identifier: NCT03971591
• Recruitment Status: Recruiting
• First Posted: June 3, 2019
• Last Update Posted: August 13, 2019
• Sponsor: Medical College of Wisconsin
• Collaborators: Loyola University Chicago; Marquette University; University of Illinois at Chicago
• Information provided by (Responsible Party): Melinda Stolley, Medical College of Wisconsin

Tracking Information

• First Submitted Date: May 9, 2019
• First Posted Date: June 3, 2019
• Last Update Posted Date: August 13, 2019
• Actual Study Start Date: June 1, 2019
• Estimated Primary Completion Date: June 30, 2022 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: May 31, 2019)

• Change in body composition [ Time Frame: Change from Baseline to 4 month ]
  Ratio of percent lean mass to percent adiposity as measured by DEXA. More lean mass and less adiposity is favorable.
• Change in body composition [ Time Frame: Change from Baseline to 12 month ]
  Ratio of percent lean mass to percent adiposity as measured by DEXA. More lean mass and less adiposity is favorable.
• Increase in intake of fruits and vegetables [ Time Frame: Change from Baseline to 4 month ]
  VioScreen's dietary analysis of self reported food consumption
• Increase in intake of fruits and vegetables [ Time Frame: Change from Baseline to 12 month ]
  VioScreen's dietary analysis of self reported food consumption
• Decrease of intake of red meat/processed meat [ Time Frame: Change from Baseline to 4 month ]
  VioScreen's dietary analysis of self reported food consumption
• Decrease of intake of red meat/processed meat [ Time Frame: Change from Baseline to 12 month ]
  VioScreen's dietary analysis of self reported food consumption
• Increase in levels of physical activity- minutes per week [ Time Frame: Change from Baseline to 4 month ]
  Change of ActiGraph monitored activity
• Increase in levels of physical activity- minutes per week [ Time Frame: Change from Baseline to 12 month ]
  Change of ActiGraph monitored activity
• Increase in levels of physical activity- #times per week [ Time Frame: Change from Baseline to 4 month ]
  Change of ActiGraph monitored activity
• Increase in levels of physical activity- #times per week [ Time Frame: Change from Baseline to 12 month ]
  Change of ActiGraph monitored activity
• Increase in resistance training- Lower extremity strength [ Time Frame: Change from Baseline to 4 month ]
  Isokinetic dynamometer (HUMAC Norm, Stoughton, MA).
• Increase in resistance training- Lower extremity strength [ Time Frame: Change from Baseline to 12 month ]
  Isokinetic dynamometer (HUMAC Norm, Stoughton, MA).
• Increase in resistance training- Handgrip strength [ Time Frame: Change from Baseline to 4 month ]
  Takei 5401 Hand Grip Digital Dynamometer
• Increase in resistance training- Handgrip strength [ Time Frame: Change from Baseline to 12 month ]
  Takei 5401 Hand Grip Digital Dynamometer
• Increase in resistance training- Strength and endurance [ Time Frame: Change from Baseline to 4 month ]
  30-Second Chair Stand (Sit to Stand)
• Increase in resistance training- Strength and endurance [ Time Frame: Change from Baseline to 12 month ]
  30-Second Chair Stand (Sit to Stand)
• Change in Quality of Life- PROMIS [ Time Frame: Change from Baseline to 4 month ]
  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 in Quality of Life-PROMIS [ Time Frame: Change from Baseline to 4 month ]
  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 in Urban life stress inventory- Crisys [ Time Frame: Change from Baseline to 4 month ]
  Measure change of mean in positive/negative/neutral and resolved/ongoing
• Change in Urban life stress inventory-Crisys [ Time Frame: Change from Baseline to 12 month ]
  Measure change of mean in positive/negative/neutral and resolved/ongoing
• Changes in Blood Pressure [ Time Frame: Change from Baseline to 4 month ]
  Participants blood pressure will be measured using a digital, automated unit
• Change in Blood Pressure [ Time Frame: Change from Baseline to 12 month ]
  Participants blood pressure will be measured using a digital, automated unit
• Change in Biomarkers- Hemoglobin [ Time Frame: Change from Baseline to 4 month ]
  Hemoglobin blood tests measured by Wisconsin Diagnostic Laboratory
• Change in Biomarkers-Hemoglobin [ Time Frame: Change from Baseline to 12 month ]
  Hemoglobin blood tests measured by Wisconsin Diagnostic Laboratory
• Change in Biomarkers- A1C [ Time Frame: Change from Baseline to 4 month ]
  A1C blood tests measured by Wisconsin Diagnostic Laboratory
• Change in Biomarkers- A1C [ Time Frame: Change from Baseline to 12 month ]
  A1C blood tests measured by Wisconsin Diagnostic Laboratory
• Change in Biomarkers- Hormones-Testosterone [ Time Frame: Change from Baseline to 4 month ]
  Testosterone blood test measured by Wisconsin Diagnostic Laboratory
• Change in Biomarkers- Hormones-Testosterone [ Time Frame: Change from Baseline to 12 month ]
  Testosterone blood test measured by Wisconsin Diagnostic Laboratory
• Change in Biomarkers- Hormones- Estradiol [ Time Frame: Change from Baseline to 4 month ]
  Estradiol blood test measured by Wisconsin Diagnostic Laboratory
• Change in Biomarkers- Hormones- Estradiol [ Time Frame: Change from Baseline to 12 month ]
  Estradiol blood test measured by Wisconsin Diagnostic Laboratory
• Change in Biomarkers- Hormones- SHBG [ Time Frame: Change from Baseline to 4 month ]
  SHBG blood test measured by Wisconsin Diagnostic Laboratory
• Change in Biomarkers- Hormones- SHBG [ Time Frame: Change from Baseline to 12 month ]
  SHBG blood test measured by Wisconsin Diagnostic Laboratory
• Change in Biomarkers-Adipokines- Leptin [ Time Frame: Change from Baseline to 4 month ]
  Leptin blood test measured by Wisconsin Diagnostic Laboratory
• Change in Biomarkers-Adipokines- Leptin [ Time Frame: Change from Baseline to 12 month ]
  Leptin,blood test measured by Wisconsin Diagnostic Laboratory
• Change in Biomarkers-Adipokines-Adiponectin [ Time Frame: Change from Baseline to 4 month ]
  Adiponectin blood test measured by Wisconsin Diagnostic Laboratory
• Change in Biomarkers-Adipokines-Adiponectin [ Time Frame: Change from Baseline to 12 month ]
  Adiponectin blood test measured by Wisconsin Diagnostic Laboratory
• Change in Biomarkers-Inflammation- IL-6 [ Time Frame: Change from Baseline to 4 month ]
  IL-6 blood test measured by Wisconsin Diagnostic Laboratory
• Change in Biomarkers-Inflammation- IL-6 [ Time Frame: Change from Baseline to 12 month ]
  IL-6 blood test measured by Wisconsin Diagnostic Laboratory Wisconsin
• Change in Biomarkers-Inflammation-TNFα [ Time Frame: Change from Baseline to 4 month ]
  TNFα blood test measured by Wisconsin Diagnostic Laboratory
• Change in Biomarkers-Inflammation-TNFα [ Time Frame: Change from Baseline to 12 month ]
  TNFα blood test measured by Wisconsin Diagnostic Laboratory
• Change in Biomarkers-Insulin Resistance-C-Peptide [ Time Frame: Change from Baseline to 4 month ]
  C-Peptide blood test measured by Wisconsin Diagnostic Laboratory
• Change in Biomarkers-Insulin Resistance- C-Peptide [ Time Frame: Change from Baseline to 12 month ]
  C-Peptide blood test measured by Wisconsin Diagnostic Laboratory
• Change in Biomarkers-Insulin Resistance-IGF-1 [ Time Frame: Change from Baseline to 4 month ]
  IGF-1 blood test measured by Wisconsin Diagnostic Laboratory
• Change in Biomarkers Insulin Resistance-IGF-1 [ Time Frame: Change from Baseline to 12 month ]
  IGF-1 blood test measured by Wisconsin Diagnostic Laboratory

• Original Primary Outcome Measures: Same as current
• Change History: Complete list of historical versions of study NCT03971591 on ClinicalTrials.gov Archive Site
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Men Moving Forward: A Lifestyle Program for African-American Prostate Cancer Survivors
• Official Title: Men Moving Forward: A Lifestyle Program for African-American Prostate Cancer Survivors
• 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).

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
• Study Phase: Not Applicable

Study Design

Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

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

Masking: None (Open Label)
Primary Purpose: Supportive Care

• Condition: Prostate Cancer

Intervention

Behavioral: 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.

Study Arms

• Experimental: Guided 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.
  Intervention: Behavioral: Guided Lifestyle Program Intervention
• Active Comparator: Self-Guided Lifestyle program
  In the self-guided weight loss program, participants will be given the sane informational binder with health and exercise information and tools as directed by ACS nutrition and physical activity guidelines but they will not receive in-person classes or text messaging. The study team will call these participants once a month to check in.
  Intervention: Behavioral: Guided Lifestyle Program Intervention

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: May 31, 2019): 200
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: June 30, 2023
• Estimated Primary Completion Date: June 30, 2022 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

Sex/Gender

• Sexes Eligible for Study: Male
• Gender Based Eligibility: Yes
• Gender Eligibility Description: Male Prostate Cancer study participants

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: Jo Bergholte, MLIS; 414-805-6990; jbergholte@mcw.edu

Contact: Kathleen Jensik, MSW; 414-955-2114; kjensik@mcw.edu

• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT03971591
• Other Study ID Numbers: PRO00031416
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

• IPD Sharing Statement: Not Provided
• Responsible Party: Melinda Stolley, Medical College of Wisconsin
• Study Sponsor: Medical College of Wisconsin

Collaborators

• Loyola University Chicago
• Marquette University
• University of Illinois at Chicago

• Investigators: Not Provided
• PRS Account: Medical College of Wisconsin
• Verification Date: August 2019