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Physical Activity Intervention in African American Men After Radical Prostatectomy

Primary Purpose

Prostatectomy, Prostate Cancer

Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Community Health Activities Model Program for Seniors (CHAMPS)
Lifetime Total Physical Activity Questionnaire
Expanded Prostate Cancer Index Composite (EPIC)
International Physical Activity Prevalence Study Environmental Module
Godin Leisure-Time Exercise Questionnaire (GLTEQ)
Questionnaire regarding behavior/lifestyle changes since diagnosis
12 week Walking Program
12 week Resistance Training Program
Sponsored by
Washington University School of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Prostatectomy

Eligibility Criteria

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

Inclusion Criteria:

  • Speaks English
  • African American
  • Radical prostatectomy for treatment of prostate cancer within the past 12 months
  • Cleared by physician to safely participate in a physical exercise program

Exclusion Criteria:

  • Does not speak English
  • Non-African American
  • Previously undergone radiation treatment to the pelvis
  • Previously undergone major pelvic surgery
  • Known urethral stricture, colostomy, or inability to urinate requiring chronic urinary catheter

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Experimental

    Active Comparator

    Arm Label

    Arm 1: Aerobics

    Arm 2: Resistance training

    Arm 3: Usual care

    Arm Description

    Complete baseline questionnaires either online or on paper Questionnaires will also be completed at 6 weeks, 12 weeks, and 16 weeks after baseline Participants will be asked to wear an accelerometer for 7 days at baseline, 12 weeks, and 16 weeks. Receive printed materials from the American Cancer Society about cancer management and standard physical activity recommendations. Require physical evaluation and orientation to the WellAware gym 12 week walking program at the WellAware Center required to check in with gym staff to check attendance advised to walk at own pace for 3 days per week 15 minutes per day for the first 2 weeks 30 minutes per day for the next 2 weeks 50 minutes or more for remaining weeks

    Complete baseline questionnaires either online or on paper Questionnaires will also be completed at 6 weeks, 12 weeks, and 16 weeks after baseline Participants will be asked to wear an accelerometer for 7 days at baseline, 12 weeks, and 16 weeks. Receive printed materials from the American Cancer Society about cancer management and standard physical activity recommendations. Require physical evaluation and orientation to the WellAware gym 12 week weight lifting program at WellAware Center exercise physiologists will work with each patient to develop a custom routine exercise load will start at 60% of one-repetition maximum and progress from 8 to 12 repetitions 2-4 sets of repetition exercises will be performed to target upper & lower muscle groups resistance load will be added by 5 pounds when patients can complete more than 12 repetitions

    Complete baseline questionnaires either online or on paper Questionnaires will also be completed at 6 weeks, 12 weeks, and 16 weeks after baseline Participants will be asked to wear an accelerometer for 7 days at baseline, 12 weeks, and 16 weeks. Receive printed materials from the American Cancer Society about cancer management and standard physical activity recommendations.

    Outcomes

    Primary Outcome Measures

    Recruitment rate comparisons between physician referral and community advertisement
    Attrition rate in each arm
    Evaluate percentage of finished duration of walking in each session and percentage of total finished session in the aerobic exercise arm. Evaluate the percentage of attended sessions in the resistance training arm
    Intervention effectiveness as measured by change in accelerometer measured physical activity
    Intervention effectiveness as measured by change in self-reported urinary/sexual function as measured by Expanded Prostate Cancer Index Composite (EPIC)
    -Intervention effectiveness will be compared between the three arms by comparing the change in self-reported urinary and sexual function. Mixed effects regression will be used to account for the longitudinal design.

    Secondary Outcome Measures

    Full Information

    First Posted
    November 25, 2015
    Last Updated
    January 28, 2016
    Sponsor
    Washington University School of Medicine
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02621684
    Brief Title
    Physical Activity Intervention in African American Men After Radical Prostatectomy
    Official Title
    A Pilot Study of Physical Activity Intervention in African American Men After Radical Prostatectomy
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2016
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    Not able to enroll any participants due to disinterest
    Study Start Date
    November 2014 (undefined)
    Primary Completion Date
    December 2015 (Anticipated)
    Study Completion Date
    December 2015 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Washington University School of Medicine

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The purpose of this pilot study is to evaluate the feasibility of recruiting African American prostate cancer survivors to a 12 week physical activity intervention study of three arms (aerobics, resistance training, and usual care) through physician referral and community advertisement strategies. In addition, the investigators will investigate the acceptance rate of the intervention and gather preliminary results on the effect of exercise on African American men's urinary and sexual functions. These data can then be used to refine the intervention and its implementation model, and to inform the submission of a larger grant to the National Institutes of Health.

    6. Conditions and Keywords

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

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Arm 1: Aerobics
    Arm Type
    Experimental
    Arm Description
    Complete baseline questionnaires either online or on paper Questionnaires will also be completed at 6 weeks, 12 weeks, and 16 weeks after baseline Participants will be asked to wear an accelerometer for 7 days at baseline, 12 weeks, and 16 weeks. Receive printed materials from the American Cancer Society about cancer management and standard physical activity recommendations. Require physical evaluation and orientation to the WellAware gym 12 week walking program at the WellAware Center required to check in with gym staff to check attendance advised to walk at own pace for 3 days per week 15 minutes per day for the first 2 weeks 30 minutes per day for the next 2 weeks 50 minutes or more for remaining weeks
    Arm Title
    Arm 2: Resistance training
    Arm Type
    Experimental
    Arm Description
    Complete baseline questionnaires either online or on paper Questionnaires will also be completed at 6 weeks, 12 weeks, and 16 weeks after baseline Participants will be asked to wear an accelerometer for 7 days at baseline, 12 weeks, and 16 weeks. Receive printed materials from the American Cancer Society about cancer management and standard physical activity recommendations. Require physical evaluation and orientation to the WellAware gym 12 week weight lifting program at WellAware Center exercise physiologists will work with each patient to develop a custom routine exercise load will start at 60% of one-repetition maximum and progress from 8 to 12 repetitions 2-4 sets of repetition exercises will be performed to target upper & lower muscle groups resistance load will be added by 5 pounds when patients can complete more than 12 repetitions
    Arm Title
    Arm 3: Usual care
    Arm Type
    Active Comparator
    Arm Description
    Complete baseline questionnaires either online or on paper Questionnaires will also be completed at 6 weeks, 12 weeks, and 16 weeks after baseline Participants will be asked to wear an accelerometer for 7 days at baseline, 12 weeks, and 16 weeks. Receive printed materials from the American Cancer Society about cancer management and standard physical activity recommendations.
    Intervention Type
    Other
    Intervention Name(s)
    Community Health Activities Model Program for Seniors (CHAMPS)
    Intervention Description
    Physical activity questionnaire for older adults Asks about activities in the past 4 weeks 41 questions and asks to notate how long the activity took
    Intervention Type
    Other
    Intervention Name(s)
    Lifetime Total Physical Activity Questionnaire
    Intervention Description
    Questions about leisure time (27) and household activities (5) Mark if participated in the activity during the past year, ages 51-65, 35-50, 23-34, and onset of puberty through 21 years
    Intervention Type
    Other
    Intervention Name(s)
    Expanded Prostate Cancer Index Composite (EPIC)
    Intervention Description
    Measures urinary and sexual function before and after prostate cancer treatment 7 questions about urinary function 9 questions about sexual function
    Intervention Type
    Other
    Intervention Name(s)
    International Physical Activity Prevalence Study Environmental Module
    Intervention Description
    -The 17-item Physical Activity Neighborhood Environment Scale can be used to assess the environmental factors for walking and bicycling in various neighborhoods.
    Intervention Type
    Other
    Intervention Name(s)
    Godin Leisure-Time Exercise Questionnaire (GLTEQ)
    Intervention Description
    -4 item query of usual leisure time exercise habits
    Intervention Type
    Other
    Intervention Name(s)
    Questionnaire regarding behavior/lifestyle changes since diagnosis
    Intervention Type
    Other
    Intervention Name(s)
    12 week Walking Program
    Intervention Type
    Other
    Intervention Name(s)
    12 week Resistance Training Program
    Primary Outcome Measure Information:
    Title
    Recruitment rate comparisons between physician referral and community advertisement
    Time Frame
    Completion of study (approximately 3.5 years)
    Title
    Attrition rate in each arm
    Description
    Evaluate percentage of finished duration of walking in each session and percentage of total finished session in the aerobic exercise arm. Evaluate the percentage of attended sessions in the resistance training arm
    Time Frame
    Completion of study (approximately 3.5 years)
    Title
    Intervention effectiveness as measured by change in accelerometer measured physical activity
    Time Frame
    Completion of study (approximately 3.5 years)
    Title
    Intervention effectiveness as measured by change in self-reported urinary/sexual function as measured by Expanded Prostate Cancer Index Composite (EPIC)
    Description
    -Intervention effectiveness will be compared between the three arms by comparing the change in self-reported urinary and sexual function. Mixed effects regression will be used to account for the longitudinal design.
    Time Frame
    Completion of study (approximately 3.5 years)

    10. Eligibility

    Sex
    Male
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Speaks English African American Radical prostatectomy for treatment of prostate cancer within the past 12 months Cleared by physician to safely participate in a physical exercise program Exclusion Criteria: Does not speak English Non-African American Previously undergone radiation treatment to the pelvis Previously undergone major pelvic surgery Known urethral stricture, colostomy, or inability to urinate requiring chronic urinary catheter
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Lin Yang, Ph.D.
    Organizational Affiliation
    Washington University School of Medicine
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Links:
    URL
    http://www.siteman.wustl.edu
    Description
    Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine

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