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

Study Overview
=================
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.

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

Conditions
-----------------
Prostate Cancer

Intervention / Treatment
-----------------
* Behavioral: Immediate Guided Lifestyle Program Intervention


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Participants will be randomized to either a guided or self-guided lifestyle intervention
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Immediate Lifestyle program<br>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<br>* 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.<br>|
| Other: Waitlist Control<br>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<br>* 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.<br>|

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 |