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

Primary Purpose

Prostate Cancer

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Immediate Guided Lifestyle Program Intervention
Sponsored by
Medical College of Wisconsin
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Prostate Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • Medical College of WisconsinRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Immediate Lifestyle program

Waitlist Control

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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 in body composition
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
VioScreen's dietary analysis of self reported food consumption
Increase in intake of fruits and vegetables
VioScreen's dietary analysis of self reported food consumption
Decrease of intake of red meat/processed meat
VioScreen's dietary analysis of self reported food consumption
Decrease of intake of red meat/processed meat
VioScreen's dietary analysis of self reported food consumption
Increase in levels of physical activity- minutes per week
Change of ActiGraph monitored activity
Increase in levels of physical activity- minutes per week
Change of ActiGraph monitored activity
Increase in levels of physical activity- #times per week
Change of ActiGraph monitored activity
Increase in levels of physical activity- #times per week
Change of ActiGraph monitored activity
Increase in resistance training- Lower extremity strength
Isokinetic dynamometer (HUMAC Norm, Stoughton, MA).
Increase in resistance training- Lower extremity strength
Isokinetic dynamometer (HUMAC Norm, Stoughton, MA).
Increase in resistance training- Handgrip strength
Takei 5401 Hand Grip Digital Dynamometer
Increase in resistance training- Handgrip strength
Takei 5401 Hand Grip Digital Dynamometer
Increase in resistance training- Strength and endurance
30-Second Chair Stand (Sit to Stand)
Increase in resistance training- Strength and endurance
30-Second Chair Stand (Sit to Stand)
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 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 in Urban life stress inventory- Crisys
Measure change of mean in positive/negative/neutral and resolved/ongoing
Change in Urban life stress inventory-Crisys
Measure change of mean in positive/negative/neutral and resolved/ongoing
Changes in Blood Pressure
Participants blood pressure will be measured using a digital, automated unit
Change in Blood Pressure
Participants blood pressure will be measured using a digital, automated unit
Change in Biomarkers- Hemoglobin
Hemoglobin blood tests measured by Wisconsin Diagnostic Laboratory
Change in Biomarkers-Hemoglobin
Hemoglobin blood tests measured by Wisconsin Diagnostic Laboratory
Change in Biomarkers- A1C
A1C blood tests measured by Wisconsin Diagnostic Laboratory
Change in Biomarkers- A1C
A1C blood tests measured by Wisconsin Diagnostic Laboratory
Change in Biomarkers- Hormones-Testosterone
Testosterone blood test measured by Wisconsin Diagnostic Laboratory
Change in Biomarkers- Hormones-Testosterone
Testosterone blood test measured by Wisconsin Diagnostic Laboratory
Change in Biomarkers- Hormones- Estradiol
Estradiol blood test measured by Wisconsin Diagnostic Laboratory
Change in Biomarkers- Hormones- Estradiol
Estradiol blood test measured by Wisconsin Diagnostic Laboratory
Change in Biomarkers- Hormones- SHBG
SHBG blood test measured by Wisconsin Diagnostic Laboratory
Change in Biomarkers- Hormones- SHBG
SHBG blood test measured by Wisconsin Diagnostic Laboratory
Change in Biomarkers-Adipokines- Leptin
Leptin blood test measured by Wisconsin Diagnostic Laboratory
Change in Biomarkers-Adipokines- Leptin
Leptin,blood test measured by Wisconsin Diagnostic Laboratory
Change in Biomarkers-Adipokines-Adiponectin
Adiponectin blood test measured by Wisconsin Diagnostic Laboratory
Change in Biomarkers-Adipokines-Adiponectin
Adiponectin blood test measured by Wisconsin Diagnostic Laboratory
Change in Biomarkers-Inflammation- IL-6
IL-6 blood test measured by Wisconsin Diagnostic Laboratory
Change in Biomarkers-Inflammation- IL-6
IL-6 blood test measured by Wisconsin Diagnostic Laboratory Wisconsin
Change in Biomarkers-Inflammation-TNFα
TNFα blood test measured by Wisconsin Diagnostic Laboratory
Change in Biomarkers-Inflammation-TNFα
TNFα blood test measured by Wisconsin Diagnostic Laboratory
Change in Biomarkers-Insulin Resistance-C-Peptide
C-Peptide blood test measured by Wisconsin Diagnostic Laboratory
Change in Biomarkers-Insulin Resistance- C-Peptide
C-Peptide blood test measured by Wisconsin Diagnostic Laboratory
Change in Biomarkers-Insulin Resistance-IGF-1
IGF-1 blood test measured by Wisconsin Diagnostic Laboratory
Change in Biomarkers Insulin Resistance-IGF-1
IGF-1 blood test measured by Wisconsin Diagnostic Laboratory

Secondary Outcome Measures

Full Information

First Posted
May 9, 2019
Last Updated
October 17, 2023
Sponsor
Medical College of Wisconsin
Collaborators
Loyola University Chicago, Marquette University, University of Illinois at Chicago
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1. Study Identification

Unique Protocol Identification Number
NCT03971591
Brief Title
Men Moving Forward: A Lifestyle Program for African-American Prostate Cancer Survivors
Acronym
MMF
Official Title
Men Moving Forward: A Lifestyle Program for African-American Prostate Cancer Survivors
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 1, 2019 (Actual)
Primary Completion Date
June 30, 2024 (Anticipated)
Study Completion Date
June 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical College of Wisconsin
Collaborators
Loyola University Chicago, Marquette University, University of Illinois at Chicago

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Participants will be randomized to either a guided or self-guided lifestyle intervention
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Immediate Lifestyle program
Arm Type
Experimental
Arm Description
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.
Arm Title
Waitlist Control
Arm Type
Other
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Immediate Guided Lifestyle Program Intervention
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in body composition
Description
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
Title
Change in body composition
Description
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
Title
Increase in intake of fruits and vegetables
Description
VioScreen's dietary analysis of self reported food consumption
Time Frame
Change from Baseline to 4 month
Title
Increase in intake of fruits and vegetables
Description
VioScreen's dietary analysis of self reported food consumption
Time Frame
Change from Baseline to 12 month
Title
Decrease of intake of red meat/processed meat
Description
VioScreen's dietary analysis of self reported food consumption
Time Frame
Change from Baseline to 4 month
Title
Decrease of intake of red meat/processed meat
Description
VioScreen's dietary analysis of self reported food consumption
Time Frame
Change from Baseline to 12 month
Title
Increase in levels of physical activity- minutes per week
Description
Change of ActiGraph monitored activity
Time Frame
Change from Baseline to 4 month
Title
Increase in levels of physical activity- minutes per week
Description
Change of ActiGraph monitored activity
Time Frame
Change from Baseline to 12 month
Title
Increase in levels of physical activity- #times per week
Description
Change of ActiGraph monitored activity
Time Frame
Change from Baseline to 4 month
Title
Increase in levels of physical activity- #times per week
Description
Change of ActiGraph monitored activity
Time Frame
Change from Baseline to 12 month
Title
Increase in resistance training- Lower extremity strength
Description
Isokinetic dynamometer (HUMAC Norm, Stoughton, MA).
Time Frame
Change from Baseline to 4 month
Title
Increase in resistance training- Lower extremity strength
Description
Isokinetic dynamometer (HUMAC Norm, Stoughton, MA).
Time Frame
Change from Baseline to 12 month
Title
Increase in resistance training- Handgrip strength
Description
Takei 5401 Hand Grip Digital Dynamometer
Time Frame
Change from Baseline to 4 month
Title
Increase in resistance training- Handgrip strength
Description
Takei 5401 Hand Grip Digital Dynamometer
Time Frame
Change from Baseline to 12 month
Title
Increase in resistance training- Strength and endurance
Description
30-Second Chair Stand (Sit to Stand)
Time Frame
Change from Baseline to 4 month
Title
Increase in resistance training- Strength and endurance
Description
30-Second Chair Stand (Sit to Stand)
Time Frame
Change from Baseline to 12 month
Title
Change in Quality of Life- PROMIS
Description
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
Title
Change in Quality of Life-PROMIS
Description
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
Title
Change in Urban life stress inventory- Crisys
Description
Measure change of mean in positive/negative/neutral and resolved/ongoing
Time Frame
Change from Baseline to 4 month
Title
Change in Urban life stress inventory-Crisys
Description
Measure change of mean in positive/negative/neutral and resolved/ongoing
Time Frame
Change from Baseline to 12 month
Title
Changes in Blood Pressure
Description
Participants blood pressure will be measured using a digital, automated unit
Time Frame
Change from Baseline to 4 month
Title
Change in Blood Pressure
Description
Participants blood pressure will be measured using a digital, automated unit
Time Frame
Change from Baseline to 12 month
Title
Change in Biomarkers- Hemoglobin
Description
Hemoglobin blood tests measured by Wisconsin Diagnostic Laboratory
Time Frame
Change from Baseline to 4 month
Title
Change in Biomarkers-Hemoglobin
Description
Hemoglobin blood tests measured by Wisconsin Diagnostic Laboratory
Time Frame
Change from Baseline to 12 month
Title
Change in Biomarkers- A1C
Description
A1C blood tests measured by Wisconsin Diagnostic Laboratory
Time Frame
Change from Baseline to 4 month
Title
Change in Biomarkers- A1C
Description
A1C blood tests measured by Wisconsin Diagnostic Laboratory
Time Frame
Change from Baseline to 12 month
Title
Change in Biomarkers- Hormones-Testosterone
Description
Testosterone blood test measured by Wisconsin Diagnostic Laboratory
Time Frame
Change from Baseline to 4 month
Title
Change in Biomarkers- Hormones-Testosterone
Description
Testosterone blood test measured by Wisconsin Diagnostic Laboratory
Time Frame
Change from Baseline to 12 month
Title
Change in Biomarkers- Hormones- Estradiol
Description
Estradiol blood test measured by Wisconsin Diagnostic Laboratory
Time Frame
Change from Baseline to 4 month
Title
Change in Biomarkers- Hormones- Estradiol
Description
Estradiol blood test measured by Wisconsin Diagnostic Laboratory
Time Frame
Change from Baseline to 12 month
Title
Change in Biomarkers- Hormones- SHBG
Description
SHBG blood test measured by Wisconsin Diagnostic Laboratory
Time Frame
Change from Baseline to 4 month
Title
Change in Biomarkers- Hormones- SHBG
Description
SHBG blood test measured by Wisconsin Diagnostic Laboratory
Time Frame
Change from Baseline to 12 month
Title
Change in Biomarkers-Adipokines- Leptin
Description
Leptin blood test measured by Wisconsin Diagnostic Laboratory
Time Frame
Change from Baseline to 4 month
Title
Change in Biomarkers-Adipokines- Leptin
Description
Leptin,blood test measured by Wisconsin Diagnostic Laboratory
Time Frame
Change from Baseline to 12 month
Title
Change in Biomarkers-Adipokines-Adiponectin
Description
Adiponectin blood test measured by Wisconsin Diagnostic Laboratory
Time Frame
Change from Baseline to 4 month
Title
Change in Biomarkers-Adipokines-Adiponectin
Description
Adiponectin blood test measured by Wisconsin Diagnostic Laboratory
Time Frame
Change from Baseline to 12 month
Title
Change in Biomarkers-Inflammation- IL-6
Description
IL-6 blood test measured by Wisconsin Diagnostic Laboratory
Time Frame
Change from Baseline to 4 month
Title
Change in Biomarkers-Inflammation- IL-6
Description
IL-6 blood test measured by Wisconsin Diagnostic Laboratory Wisconsin
Time Frame
Change from Baseline to 12 month
Title
Change in Biomarkers-Inflammation-TNFα
Description
TNFα blood test measured by Wisconsin Diagnostic Laboratory
Time Frame
Change from Baseline to 4 month
Title
Change in Biomarkers-Inflammation-TNFα
Description
TNFα blood test measured by Wisconsin Diagnostic Laboratory
Time Frame
Change from Baseline to 12 month
Title
Change in Biomarkers-Insulin Resistance-C-Peptide
Description
C-Peptide blood test measured by Wisconsin Diagnostic Laboratory
Time Frame
Change from Baseline to 4 month
Title
Change in Biomarkers-Insulin Resistance- C-Peptide
Description
C-Peptide blood test measured by Wisconsin Diagnostic Laboratory
Time Frame
Change from Baseline to 12 month
Title
Change in Biomarkers-Insulin Resistance-IGF-1
Description
IGF-1 blood test measured by Wisconsin Diagnostic Laboratory
Time Frame
Change from Baseline to 4 month
Title
Change in Biomarkers Insulin Resistance-IGF-1
Description
IGF-1 blood test measured by Wisconsin Diagnostic Laboratory
Time Frame
Change from Baseline to 12 month

10. Eligibility

Sex
Male
Gender Based
Yes
Gender Eligibility Description
Male Prostate Cancer study participants
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jo Bergholte, MLIS
Phone
414-805-6990
Email
jbergholte@mcw.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Kathleen Jensik, MSW
Phone
414-955-2114
Email
kjensik@mcw.edu
Facility Information:
Facility Name
Medical College of Wisconsin
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kathleen OConnell, PhD
Phone
414-955-2114
Email
kaoconnell@mcw.edu
First Name & Middle Initial & Last Name & Degree
Margaret Tovar
Phone
414-955-2114
Email
mtovar@mcw.edu
First Name & Middle Initial & Last Name & Degree
Melinda Stolley, PhD

12. IPD Sharing Statement

Learn more about this trial

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

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