Physical Activity Intervention in African American Men After Radical Prostatectomy

Not Applicable

Withdrawn

• Conditions: Prostate Cancer; Prostatectomy
• Interventions: Other: Community Health Activities Model Program for Seniors (CHAMPS); Other: Lifetime Total Physical Activity Questionnaire; Other: Expanded Prostate Cancer Index Composite (EPIC); Other: International Physical Activity Prevalence Study Environmental Module; Other: Godin Leisure-Time Exercise Questionnaire (GLTEQ); Other: Questionnaire regarding behavior/lifestyle changes since diagnosis; Other: 12 week Walking Program; Other: 12 week Resistance Training Program

• Registration Number: NCT02621684
• Lead Sponsor: Washington University School of Medicine

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-11
• Study First Submitted: 2015-11-25
• Primary Completion: 2015-12
• Study Completion: 2015-12
• Study First Submitted QC: 2015-12-01
• Study First Posted: 2015-12-03
• Status Verified: 2016-01
• Last Update Submitted: 2016-01-28
• Last Update Posted: 2016-01-29

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Male
• Target Recruitment: Not specified

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm 1: Aerobics	Lifetime Total Physical Activity Questionnaire	* 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 1: Aerobics	Godin Leisure-Time Exercise Questionnaire (GLTEQ)	* 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 1: Aerobics	12 week Walking Program	* 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 1: Aerobics	Expanded Prostate Cancer Index Composite (EPIC)	* 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 1: Aerobics	International Physical Activity Prevalence Study Environmental Module	* 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 1: Aerobics	Questionnaire regarding behavior/lifestyle changes since diagnosis	* 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 3: Usual care	Lifetime Total Physical Activity Questionnaire	* 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.
Arm 3: Usual care	Godin Leisure-Time Exercise Questionnaire (GLTEQ)	* 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.
Arm 1: Aerobics	Community Health Activities Model Program for Seniors (CHAMPS)	* 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 2: Resistance training	Lifetime Total Physical Activity Questionnaire	* 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 2: Resistance training	Expanded Prostate Cancer Index Composite (EPIC)	* 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 2: Resistance training	12 week Resistance Training Program	* 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 3: Usual care	Expanded Prostate Cancer Index Composite (EPIC)	* 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.
Arm 3: Usual care	Questionnaire regarding behavior/lifestyle changes since diagnosis	* 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.
Arm 2: Resistance training	International Physical Activity Prevalence Study Environmental Module	* 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 3: Usual care	Community Health Activities Model Program for Seniors (CHAMPS)	* 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.
Arm 2: Resistance training	Community Health Activities Model Program for Seniors (CHAMPS)	* 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 2: Resistance training	Godin Leisure-Time Exercise Questionnaire (GLTEQ)	* 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 2: Resistance training	Questionnaire regarding behavior/lifestyle changes since diagnosis	* 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 3: Usual care	International Physical Activity Prevalence Study Environmental Module	* 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.

Primary Outcome Measures

Name	Time	Method
Intervention effectiveness as measured by change in accelerometer measured physical activity	Completion of study (approximately 3.5 years)
Intervention effectiveness as measured by change in self-reported urinary/sexual function as measured by Expanded Prostate Cancer Index Composite (EPIC)	Completion of study (approximately 3.5 years)	-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.
Recruitment rate comparisons between physician referral and community advertisement	Completion of study (approximately 3.5 years)
Attrition rate in each arm	Completion of study (approximately 3.5 years)	* 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