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).
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
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
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.
Medical College of Wisconsin
Milwaukee, Wisconsin, United States
Change in body composition
Ratio of percent lean mass to percent adiposity as measured by DEXA. More lean mass and less adiposity is favorable.
Time frame: 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.
Time frame: Change from Baseline to 12 month
Increase in intake of fruits and vegetables
VioScreen's dietary analysis of self reported food consumption
Time frame: Change from Baseline to 4 month
Increase in intake of fruits and vegetables
VioScreen's dietary analysis of self reported food consumption
Time frame: Change from Baseline to 12 month
Decrease of intake of red meat/processed meat
VioScreen's dietary analysis of self reported food consumption
Time frame: Change from Baseline to 4 month
Decrease of intake of red meat/processed meat
VioScreen's dietary analysis of self reported food consumption
Time frame: Change from Baseline to 12 month
Increase in levels of physical activity- minutes per week
Change of ActiGraph monitored activity
Time frame: Change from Baseline to 4 month
Increase in levels of physical activity- minutes per week
Change of ActiGraph monitored activity
Time frame: Change from Baseline to 12 month
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Masking
NONE
Enrollment
200
Increase in levels of physical activity- #times per week
Change of ActiGraph monitored activity
Time frame: Change from Baseline to 4 month
Increase in levels of physical activity- #times per week
Change of ActiGraph monitored activity
Time frame: Change from Baseline to 12 month
Increase in resistance training- Lower extremity strength
Isokinetic dynamometer (HUMAC Norm, Stoughton, MA).
Time frame: Change from Baseline to 4 month
Increase in resistance training- Lower extremity strength
Isokinetic dynamometer (HUMAC Norm, Stoughton, MA).
Time frame: Change from Baseline to 12 month
Increase in resistance training- Handgrip strength
Takei 5401 Hand Grip Digital Dynamometer
Time frame: Change from Baseline to 4 month
Increase in resistance training- Handgrip strength
Takei 5401 Hand Grip Digital Dynamometer
Time frame: Change from Baseline to 12 month
Increase in resistance training- Strength and endurance
30-Second Chair Stand (Sit to Stand)
Time frame: Change from Baseline to 4 month
Increase in resistance training- Strength and endurance
30-Second Chair Stand (Sit to Stand)
Time frame: 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.
Time frame: 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.
Time frame: Change from Baseline to 4 month
Change in Urban life stress inventory- Crisys
Measure change of mean in positive/negative/neutral and resolved/ongoing
Time frame: Change from Baseline to 4 month
Change in Urban life stress inventory-Crisys
Measure change of mean in positive/negative/neutral and resolved/ongoing
Time frame: Change from Baseline to 12 month
Changes in Blood Pressure
Participants blood pressure will be measured using a digital, automated unit
Time frame: Change from Baseline to 4 month
Change in Blood Pressure
Participants blood pressure will be measured using a digital, automated unit
Time frame: Change from Baseline to 12 month
Change in Biomarkers- Hemoglobin
Hemoglobin blood tests measured by Wisconsin Diagnostic Laboratory
Time frame: Change from Baseline to 4 month
Change in Biomarkers-Hemoglobin
Hemoglobin blood tests measured by Wisconsin Diagnostic Laboratory
Time frame: Change from Baseline to 12 month
Change in Biomarkers- A1C
A1C blood tests measured by Wisconsin Diagnostic Laboratory
Time frame: Change from Baseline to 4 month
Change in Biomarkers- A1C
A1C blood tests measured by Wisconsin Diagnostic Laboratory
Time frame: Change from Baseline to 12 month
Change in Biomarkers- Hormones-Testosterone
Testosterone blood test measured by Wisconsin Diagnostic Laboratory
Time frame: Change from Baseline to 4 month
Change in Biomarkers- Hormones-Testosterone
Testosterone blood test measured by Wisconsin Diagnostic Laboratory
Time frame: Change from Baseline to 12 month
Change in Biomarkers- Hormones- Estradiol
Estradiol blood test measured by Wisconsin Diagnostic Laboratory
Time frame: Change from Baseline to 4 month
Change in Biomarkers- Hormones- Estradiol
Estradiol blood test measured by Wisconsin Diagnostic Laboratory
Time frame: Change from Baseline to 12 month
Change in Biomarkers- Hormones- SHBG
SHBG blood test measured by Wisconsin Diagnostic Laboratory
Time frame: Change from Baseline to 4 month
Change in Biomarkers- Hormones- SHBG
SHBG blood test measured by Wisconsin Diagnostic Laboratory
Time frame: Change from Baseline to 12 month
Change in Biomarkers-Adipokines- Leptin
Leptin blood test measured by Wisconsin Diagnostic Laboratory
Time frame: Change from Baseline to 4 month
Change in Biomarkers-Adipokines- Leptin
Leptin,blood test measured by Wisconsin Diagnostic Laboratory
Time frame: Change from Baseline to 12 month
Change in Biomarkers-Adipokines-Adiponectin
Adiponectin blood test measured by Wisconsin Diagnostic Laboratory
Time frame: Change from Baseline to 4 month
Change in Biomarkers-Adipokines-Adiponectin
Adiponectin blood test measured by Wisconsin Diagnostic Laboratory
Time frame: Change from Baseline to 12 month
Change in Biomarkers-Inflammation- IL-6
IL-6 blood test measured by Wisconsin Diagnostic Laboratory
Time frame: Change from Baseline to 4 month
Change in Biomarkers-Inflammation- IL-6
IL-6 blood test measured by Wisconsin Diagnostic Laboratory Wisconsin
Time frame: Change from Baseline to 12 month
Change in Biomarkers-Inflammation-TNFα
TNFα blood test measured by Wisconsin Diagnostic Laboratory
Time frame: Change from Baseline to 4 month
Change in Biomarkers-Inflammation-TNFα
TNFα blood test measured by Wisconsin Diagnostic Laboratory
Time frame: Change from Baseline to 12 month
Change in Biomarkers-Insulin Resistance-C-Peptide
C-Peptide blood test measured by Wisconsin Diagnostic Laboratory
Time frame: Change from Baseline to 4 month
Change in Biomarkers-Insulin Resistance- C-Peptide
C-Peptide blood test measured by Wisconsin Diagnostic Laboratory
Time frame: Change from Baseline to 12 month
Change in Biomarkers-Insulin Resistance-IGF-1
IGF-1 blood test measured by Wisconsin Diagnostic Laboratory
Time frame: Change from Baseline to 4 month
Change in Biomarkers Insulin Resistance-IGF-1
IGF-1 blood test measured by Wisconsin Diagnostic Laboratory
Time frame: Change from Baseline to 12 month