Prostate Cancer
Conditions
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.
Interventions
BEHAVIORALImmediate 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.
Sponsors
Medical College of Wisconsin
Loyola University Chicago
Marquette University
University of Illinois at Chicago
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention model description
Participants will be randomized to either a guided or self-guided lifestyle intervention
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in body composition | 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. |
| Increase in intake of fruits and vegetables | Change from Baseline to 4 month | VioScreen's dietary analysis of self reported food consumption |
| Decrease of intake of red meat/processed meat | Change from Baseline to 4 month | VioScreen's dietary analysis of self reported food consumption |
| Increase in levels of physical activity- minutes per week | Change from Baseline to 4 month | Change of ActiGraph monitored activity |
| Increase in levels of physical activity- #times per week | Change from Baseline to 4 month | Change of ActiGraph monitored activity |
| Increase in resistance training- Lower extremity strength | Change from Baseline to 4 month | Isokinetic dynamometer (HUMAC Norm, Stoughton, MA). |
| Increase in resistance training- Handgrip strength | Change from Baseline to 4 month | Takei 5401 Hand Grip Digital Dynamometer |
| Increase in resistance training- Strength and endurance | Change from Baseline to 4 month | 30-Second Chair Stand (Sit to Stand) |
| Change in Quality of Life- PROMIS | 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 | 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 | Change from Baseline to 4 month | Measure change of mean in positive/negative/neutral and resolved/ongoing |
| Change in Urban life stress inventory-Crisys | Change from Baseline to 12 month | Measure change of mean in positive/negative/neutral and resolved/ongoing |
| Changes in Blood Pressure | Change from Baseline to 4 month | Participants blood pressure will be measured using a digital, automated unit |
| Change in Blood Pressure | Change from Baseline to 12 month | Participants blood pressure will be measured using a digital, automated unit |
| Change in Biomarkers- Hemoglobin | Change from Baseline to 4 month | Hemoglobin blood tests measured by Wisconsin Diagnostic Laboratory |
| Change in Biomarkers-Hemoglobin | Change from Baseline to 12 month | Hemoglobin blood tests measured by Wisconsin Diagnostic Laboratory |
| Change in Biomarkers- A1C | Change from Baseline to 4 month | A1C blood tests measured by Wisconsin Diagnostic Laboratory |
| Change in Biomarkers- Hormones-Testosterone | Change from Baseline to 4 month | Testosterone blood test measured by Wisconsin Diagnostic Laboratory |
| Change in Biomarkers- Hormones- Estradiol | Change from Baseline to 4 month | Estradiol blood test measured by Wisconsin Diagnostic Laboratory |
| Change in Biomarkers- Hormones- SHBG | Change from Baseline to 4 month | SHBG blood test measured by Wisconsin Diagnostic Laboratory |
| Change in Biomarkers-Adipokines- Leptin | Change from Baseline to 4 month | Leptin blood test measured by Wisconsin Diagnostic Laboratory |
| Change in Biomarkers-Adipokines-Adiponectin | Change from Baseline to 4 month | Adiponectin blood test measured by Wisconsin Diagnostic Laboratory |
| Change in Biomarkers-Inflammation- IL-6 | Change from Baseline to 4 month | IL-6 blood test measured by Wisconsin Diagnostic Laboratory |
| Change in Biomarkers-Inflammation-TNFα | Change from Baseline to 4 month | TNFα blood test measured by Wisconsin Diagnostic Laboratory |
| Change in Biomarkers-Insulin Resistance-C-Peptide | Change from Baseline to 4 month | C-Peptide blood test measured by Wisconsin Diagnostic Laboratory |
| Change in Biomarkers-Insulin Resistance- C-Peptide | Change from Baseline to 12 month | C-Peptide blood test measured by Wisconsin Diagnostic Laboratory |
| Change in Biomarkers-Insulin Resistance-IGF-1 | Change from Baseline to 4 month | IGF-1 blood test measured by Wisconsin Diagnostic Laboratory |
| Change in Biomarkers Insulin Resistance-IGF-1 | Change from Baseline to 12 month | IGF-1 blood test measured by Wisconsin Diagnostic Laboratory |
Countries
United States
Outcome results
None listed