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.

Trial Health

At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date

Timeline

Completed

Started Nov 2014

Status

withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

1.1 years study duration

Study Start

First participant enrolled

November 1, 2014

Completed

1.1 years until next milestone

First Submitted

Initial submission to the registry

November 25, 2015

Completed

6 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed

2 days until next milestone

First Posted

Study publicly available on registry

December 3, 2015

Completed

Last Updated

January 29, 2016

Status Verified

January 1, 2016

Enrollment Period

1.1 years

First QC Date

November 25, 2015

Last Update Submit

January 28, 2016

Conditions

Prostatectomy Prostate Cancer

Outcome Measures

Primary Outcomes (4)

Recruitment rate comparisons between physician referral and community advertisement
Completion of study (approximately 3.5 years)
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
Completion of study (approximately 3.5 years)
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)
-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.
Completion of study (approximately 3.5 years)

Study Arms (3)

Arm 1: Aerobics

EXPERIMENTAL

* 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

Other: Community Health Activities Model Program for Seniors (CHAMPS)Other: Lifetime Total Physical Activity QuestionnaireOther: Expanded Prostate Cancer Index Composite (EPIC)Other: International Physical Activity Prevalence Study Environmental ModuleOther: Godin Leisure-Time Exercise Questionnaire (GLTEQ)Other: Questionnaire regarding behavior/lifestyle changes since diagnosisOther: 12 week Walking Program

Arm 2: Resistance training

EXPERIMENTAL

* 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

ACTIVE COMPARATOR

Interventions

Community Health Activities Model Program for Seniors (CHAMPS)OTHER

* 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