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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT02621684
Other study ID # 201410072
Secondary ID
Status Withdrawn
Phase N/A
First received November 25, 2015
Last updated January 28, 2016
Start date November 2014
Est. completion date December 2015

Study information

Verified date January 2016
Source Washington University School of Medicine
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date December 2015
Est. primary completion date December 2015
Accepts healthy volunteers No
Gender Male
Age group 18 Years and older
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care


Related Conditions & MeSH terms


Intervention

Other:
Community Health Activities Model Program for Seniors (CHAMPS)
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
Lifetime Total Physical Activity Questionnaire
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
Expanded Prostate Cancer Index Composite (EPIC)
Measures urinary and sexual function before and after prostate cancer treatment 7 questions about urinary function 9 questions about sexual function
International Physical Activity Prevalence Study Environmental Module
-The 17-item Physical Activity Neighborhood Environment Scale can be used to assess the environmental factors for walking and bicycling in various neighborhoods.
Godin Leisure-Time Exercise Questionnaire (GLTEQ)
-4 item query of usual leisure time exercise habits
Questionnaire regarding behavior/lifestyle changes since diagnosis

12 week Walking Program

12 week Resistance Training Program


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Washington University School of Medicine

Outcome

Type Measure Description Time frame Safety issue
Primary Recruitment rate comparisons between physician referral and community advertisement Completion of study (approximately 3.5 years) No
Primary 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) No
Primary Intervention effectiveness as measured by change in accelerometer measured physical activity Completion of study (approximately 3.5 years) No
Primary 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) No
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