Physical Activity Intervention in African American Men After Radical Prostatectomy

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

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.

Study Overview

• Status: Withdrawn
• Conditions: Prostate Cancer; Prostatectomy
• Intervention / Treatment: 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

• Study Type: Interventional
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm 1: Aerobics; 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 Centerrequired to check in with gym staff to check attendanceadvised to walk at own pace for 3 days per week15 minutes per day for the first 2 weeks30 minutes per day for the next 2 weeks50 minutes or more for remaining weeks	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; Other: 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; Other: 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; Other: 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.; Other: Godin Leisure-Time Exercise Questionnaire (GLTEQ); -4 item query of usual leisure time exercise habits; Other: Questionnaire regarding behavior/lifestyle changes since diagnosis; Other: 12 week Walking Program
Experimental: Arm 2: Resistance training; 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 Centerexercise physiologists will work with each patient to develop a custom routineexercise load will start at 60% of one-repetition maximum and progress from 8 to 12 repetitions2-4 sets of repetition exercises will be performed to target upper & lower muscle groupsresistance load will be added by 5 pounds when patients can complete more than 12 repetitions	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; Other: 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; Other: 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; Other: 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.; Other: Godin Leisure-Time Exercise Questionnaire (GLTEQ); -4 item query of usual leisure time exercise habits; Other: Questionnaire regarding behavior/lifestyle changes since diagnosis; Other: 12 week Resistance Training Program
Active Comparator: Arm 3: Usual care; 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.	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; Other: 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; Other: 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; Other: 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.; Other: Godin Leisure-Time Exercise Questionnaire (GLTEQ); -4 item query of usual leisure time exercise habits; Other: Questionnaire regarding behavior/lifestyle changes since diagnosis

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)

Collaborators and Investigators

• Sponsor: Washington University School of Medicine
• Investigators: Principal Investigator: Lin Yang, Ph.D., Washington University School of Medicine

Publications and helpful links

Helpful Links

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

Study record dates

Study Major Dates

• Study Start: November 1, 2014
• Primary Completion (Anticipated): December 1, 2015
• Study Completion (Anticipated): December 1, 2015

Study Registration Dates

• First Submitted: November 25, 2015
• First Submitted That Met QC Criteria: December 1, 2015
• First Posted (Estimate): December 3, 2015

Study Record Updates

• Last Update Posted (Estimate): January 29, 2016
• Last Update Submitted That Met QC Criteria: January 28, 2016
• Last Verified: January 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Prostatic Neoplasms
• Other Study ID Numbers: 201410072