Clinical trial NCT03971591: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Prostate Cancer
Lead sponsor: Medical College of Wisconsin
Sponsor class: OTHER
Collaborators: name: Loyola University Chicago
name: Marquette University
name: University of Illinois at Chicago
First posted: 2019-06-03
Enrollment: 200
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomized to either a guided or self-guided lifestyle intervention
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Change in body composition
timeFrame: Change from Baseline to 4 month
measure: Change in body composition
timeFrame: Change from Baseline to 12 month
measure: Increase in intake of fruits and vegetables
timeFrame: Change from Baseline to 4 month
measure: Increase in intake of fruits and vegetables
timeFrame: Change from Baseline to 12 month
measure: Decrease of intake of red meat/processed meat
timeFrame: Change from Baseline to 4 month
measure: Decrease of intake of red meat/processed meat
timeFrame: Change from Baseline to 12 month
measure: Increase in levels of physical activity- minutes per week
timeFrame: Change from Baseline to 4 month
measure: Increase in levels of physical activity- minutes per week
timeFrame: Change from Baseline to 12 month
measure: Increase in levels of physical activity- #times per week
timeFrame: Change from Baseline to 4 month
measure: Increase in levels of physical activity- #times per week
timeFrame: Change from Baseline to 12 month
measure: Increase in resistance training- Lower extremity strength
timeFrame: Change from Baseline to 4 month
measure: Increase in resistance training- Lower extremity strength
timeFrame: Change from Baseline to 12 month
measure: Increase in resistance training- Handgrip strength
timeFrame: Change from Baseline to 4 month
measure: Increase in resistance training- Handgrip strength
timeFrame: Change from Baseline to 12 month
measure: Increase in resistance training- Strength and endurance
timeFrame: Change from Baseline to 4 month
measure: Increase in resistance training- Strength and endurance
timeFrame: Change from Baseline to 12 month
measure: Change in Quality of Life- PROMIS
timeFrame: Change from Baseline to 4 month
measure: Change in Quality of Life-PROMIS
timeFrame: Change from Baseline to 4 month
measure: Change in Urban life stress inventory- Crisys
timeFrame: Change from Baseline to 4 month
measure: Change in Urban life stress inventory-Crisys
timeFrame: Change from Baseline to 12 month
measure: Changes in Blood Pressure
timeFrame: Change from Baseline to 4 month
measure: Change in Blood Pressure
timeFrame: Change from Baseline to 12 month
measure: Change in Biomarkers- Hemoglobin
timeFrame: Change from Baseline to 4 month
measure: Change in Biomarkers-Hemoglobin
timeFrame: Change from Baseline to 12 month
measure: Change in Biomarkers- A1C
timeFrame: Change from Baseline to 4 month
measure: Change in Biomarkers- A1C
timeFrame: Change from Baseline to 12 month
measure: Change in Biomarkers- Hormones-Testosterone
timeFrame: Change from Baseline to 4 month
measure: Change in Biomarkers- Hormones-Testosterone
timeFrame: Change from Baseline to 12 month
measure: Change in Biomarkers- Hormones- Estradiol
timeFrame: Change from Baseline to 4 month
measure: Change in Biomarkers- Hormones- Estradiol
timeFrame: Change from Baseline to 12 month
measure: Change in Biomarkers- Hormones- SHBG
timeFrame: Change from Baseline to 4 month
measure: Change in Biomarkers- Hormones- SHBG
timeFrame: Change from Baseline to 12 month
measure: Change in Biomarkers-Adipokines- Leptin
timeFrame: Change from Baseline to 4 month
measure: Change in Biomarkers-Adipokines- Leptin
timeFrame: Change from Baseline to 12 month
measure: Change in Biomarkers-Adipokines-Adiponectin
timeFrame: Change from Baseline to 4 month
measure: Change in Biomarkers-Adipokines-Adiponectin
timeFrame: Change from Baseline to 12 month
measure: Change in Biomarkers-Inflammation- IL-6
timeFrame: Change from Baseline to 4 month
measure: Change in Biomarkers-Inflammation- IL-6
timeFrame: Change from Baseline to 12 month
measure: Change in Biomarkers-Inflammation-TNFα
timeFrame: Change from Baseline to 4 month
measure: Change in Biomarkers-Inflammation-TNFα
timeFrame: Change from Baseline to 12 month
measure: Change in Biomarkers-Insulin Resistance-C-Peptide
timeFrame: Change from Baseline to 4 month
measure: Change in Biomarkers-Insulin Resistance- C-Peptide
timeFrame: Change from Baseline to 12 month
measure: Change in Biomarkers-Insulin Resistance-IGF-1
timeFrame: Change from Baseline to 4 month
measure: Change in Biomarkers Insulin Resistance-IGF-1
timeFrame: Change from Baseline to 12 month
Secondary outcomes:
Other outcomes:
Locations:
city: Milwaukee
country: United States
facility: Medical College of Wisconsin
state: Wisconsin
Study officials:
References: