Physical Activity Intervention in African American Men After Radical Prostatectomy

Prostate Cancer Clinical Trial

Official title:

A Pilot Study of Physical Activity Intervention in African American Men After Radical Prostatectomy

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02621684
• Other study ID #: 201410072
• Status: Withdrawn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• Status: Withdrawn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

• Prostate Cancer
• Prostatectomy

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

External Links

•   Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine