Men Moving Forward: A Lifestyle Program for African-American Prostate Cancer Survivors
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 125
- 试验地点
- 1
- 主要终点
- Change in body composition
研究概览
简要总结
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).
详细描述
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)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •• Does not meet the Inclusion Criteria
研究组 & 干预措施
Immediate 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.
干预措施: Immediate Guided Lifestyle Program Intervention (Behavioral)
Waitlist Control
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.
干预措施: Immediate Guided Lifestyle Program Intervention (Behavioral)
结局指标
主要结局
Change in body composition
时间窗: 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.
Change in Biomarkers-Adipokines- Leptin
时间窗: Change from Baseline to 12 month
Leptin,blood test measured by Wisconsin Diagnostic Laboratory
Increase in resistance training- Strength and endurance
时间窗: Change from Baseline to 12 month
30-Second Chair Stand (Sit to Stand)
Increase in resistance training- Lower extremity strength
时间窗: Change from Baseline to 12 month
Isokinetic dynamometer (HUMAC Norm, Stoughton, MA).
Change in Quality of Life- PROMIS
时间窗: 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 Biomarkers- A1C
时间窗: Change from Baseline to 12 month
A1C blood tests measured by Wisconsin Diagnostic Laboratory
Change in Biomarkers-Adipokines-Adiponectin
时间窗: Change from Baseline to 12 month
Adiponectin blood test measured by Wisconsin Diagnostic Laboratory
Change in Biomarkers-Insulin Resistance-C-Peptide
时间窗: Change from Baseline to 4 month
C-Peptide blood test measured by Wisconsin Diagnostic Laboratory
Change in Biomarkers Insulin Resistance-IGF-1
时间窗: Change from Baseline to 12 month
IGF-1 blood test measured by Wisconsin Diagnostic Laboratory
Decrease of intake of red meat/processed meat
时间窗: Change from Baseline to 12 month
VioScreen's dietary analysis of self reported food consumption
Increase in levels of physical activity- minutes per week
时间窗: Change from Baseline to 12 month
Change of ActiGraph monitored activity
Increase in levels of physical activity- #times per week
时间窗: Change from Baseline to 12 month
Change of ActiGraph monitored activity
Change in Quality of Life-PROMIS
时间窗: 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
时间窗: Change from Baseline to 4 month
Measure change of mean in positive/negative/neutral and resolved/ongoing
Changes in Blood Pressure
时间窗: Change from Baseline to 4 month
Participants blood pressure will be measured using a digital, automated unit
Change in Blood Pressure
时间窗: Change from Baseline to 12 month
Participants blood pressure will be measured using a digital, automated unit
Change in Biomarkers-Hemoglobin
时间窗: Change from Baseline to 12 month
Hemoglobin blood tests measured by Wisconsin Diagnostic Laboratory
Change in Biomarkers-Inflammation- IL-6
时间窗: Change from Baseline to 12 month
IL-6 blood test measured by Wisconsin Diagnostic Laboratory Wisconsin
Change in Biomarkers-Inflammation-TNFα
时间窗: Change from Baseline to 12 month
TNFα blood test measured by Wisconsin Diagnostic Laboratory
Increase in intake of fruits and vegetables
时间窗: Change from Baseline to 12 month
VioScreen's dietary analysis of self reported food consumption
Increase in resistance training- Handgrip strength
时间窗: Change from Baseline to 12 month
Takei 5401 Hand Grip Digital Dynamometer
Change in Biomarkers- Hemoglobin
时间窗: Change from Baseline to 4 month
Hemoglobin blood tests measured by Wisconsin Diagnostic Laboratory
Change in Biomarkers- Hormones- SHBG
时间窗: Change from Baseline to 12 month
SHBG blood test measured by Wisconsin Diagnostic Laboratory
Change in Biomarkers-Insulin Resistance- C-Peptide
时间窗: Change from Baseline to 12 month
C-Peptide blood test measured by Wisconsin Diagnostic Laboratory
Change in Biomarkers-Insulin Resistance-IGF-1
时间窗: Change from Baseline to 4 month
IGF-1 blood test measured by Wisconsin Diagnostic Laboratory
Change in Urban life stress inventory-Crisys
时间窗: Change from Baseline to 12 month
Measure change of mean in positive/negative/neutral and resolved/ongoing
Change in Biomarkers- Hormones-Testosterone
时间窗: Change from Baseline to 12 month
Testosterone blood test measured by Wisconsin Diagnostic Laboratory
Change in Biomarkers- Hormones- Estradiol
时间窗: Change from Baseline to 12 month
Estradiol blood test measured by Wisconsin Diagnostic Laboratory
Change in body composition
时间窗: 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
时间窗: Change from Baseline to 4 month
VioScreen's dietary analysis of self reported food consumption
Decrease of intake of red meat/processed meat
时间窗: Change from Baseline to 4 month
VioScreen's dietary analysis of self reported food consumption
Increase in levels of physical activity- minutes per week
时间窗: Change from Baseline to 4 month
Change of ActiGraph monitored activity
Increase in levels of physical activity- #times per week
时间窗: Change from Baseline to 4 month
Change of ActiGraph monitored activity
Increase in resistance training- Lower extremity strength
时间窗: Change from Baseline to 4 month
Isokinetic dynamometer (HUMAC Norm, Stoughton, MA).
Increase in resistance training- Handgrip strength
时间窗: Change from Baseline to 4 month
Takei 5401 Hand Grip Digital Dynamometer
Increase in resistance training- Strength and endurance
时间窗: Change from Baseline to 4 month
30-Second Chair Stand (Sit to Stand)
Change in Biomarkers- A1C
时间窗: Change from Baseline to 4 month
A1C blood tests measured by Wisconsin Diagnostic Laboratory
Change in Biomarkers- Hormones-Testosterone
时间窗: Change from Baseline to 4 month
Testosterone blood test measured by Wisconsin Diagnostic Laboratory
Change in Biomarkers- Hormones- Estradiol
时间窗: Change from Baseline to 4 month
Estradiol blood test measured by Wisconsin Diagnostic Laboratory
Change in Biomarkers- Hormones- SHBG
时间窗: Change from Baseline to 4 month
SHBG blood test measured by Wisconsin Diagnostic Laboratory
Change in Biomarkers-Adipokines- Leptin
时间窗: Change from Baseline to 4 month
Leptin blood test measured by Wisconsin Diagnostic Laboratory
Change in Biomarkers-Adipokines-Adiponectin
时间窗: Change from Baseline to 4 month
Adiponectin blood test measured by Wisconsin Diagnostic Laboratory
Change in Biomarkers-Inflammation- IL-6
时间窗: Change from Baseline to 4 month
IL-6 blood test measured by Wisconsin Diagnostic Laboratory
Change in Biomarkers-Inflammation-TNFα
时间窗: Change from Baseline to 4 month
TNFα blood test measured by Wisconsin Diagnostic Laboratory
次要结局
未报告次要终点
研究者
Melinda Stolley
Associate Director for Cancer Prevention and Control
Medical College of Wisconsin