ProstatectomyNCT02621684
Physical Activity Intervention in African American Men After Radical Prostatectomy
A study testing Community Health Activities Model Program for Seniors (CHAMPS), Lifetime Total Physical Activity Questionnaire and Expanded Prostate Cancer Index Composite (EPIC) in people with Prostatectomy and Prostate Cancer, run by Washington University School of Medicine.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostatectomy, Prostate Cancer
- What is being tested?
- Community Health Activities Model Program for Seniors (CHAMPS), Lifetime Total Physical Activity Questionnaire and Expanded Prostate Cancer Index Composite (EPIC)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Nov 2014to Dec 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
About this study
Official title: 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.
- Conditions
- Prostatectomy, Prostate Cancer
- Being tested
- Community Health Activities Model Program for Seniors (CHAMPS), Lifetime Total Physical Activity Questionnaire, Expanded Prostate Cancer Index Composite (EPIC), International Physical Activity Prevalence Study Environmental Module, Godin Leisure-Time Exercise Questionnaire (GLTEQ)
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
Lifetime Total Physical Activity QuestionnaireOther
- 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)Other
- 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 ModuleOther
-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)Other
-4 item query of usual leisure time exercise habits
Questionnaire regarding behavior/lifestyle changes since diagnosisOther
12 week Walking ProgramOther
12 week Resistance Training ProgramOther
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 |
| 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 Receives: 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 Resistance Training Program |
| Arm 3: Usual care | Active comparator | * 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. Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment rate comparisons between physician referral and community advertisement
Measured: 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
Measured: Completion of study (approximately 3.5 years)
Intervention effectiveness as measured by change in accelerometer measured physical activity
Measured: 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.
Measured: Completion of study (approximately 3.5 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2015 (estimated)
- Study startNov 2014
- Primary completionDec 2015 (estimated)
- Study completionDec 2015 (estimated)
Why it stopped: Not able to enroll any participants due to disinterest
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ProstatectomyStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lin Yang, Ph.D., Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02621684
- Sponsor's protocol ID
- 201410072
- Status last verified
- Jan 2016
- First submitted
- 25 Nov 2015
- Last updated
- 29 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of Physical Activity Intervention in African American Men After Radical Prostatectomy
- ClinicalTrials.gov ID
- NCT02621684
- Acronym / sponsor ID
- 201410072
- Conditions
- Prostatectomy, Prostate Cancer
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Not able to enroll any participants due to disinterest
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Study start
- Nov 2014
- Primary completion
- Dec 2015 (estimated)
- Study completion
- Dec 2015 (estimated)
- First posted
- 3 Dec 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Arm 1: Aerobics | Experimental | 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* 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 | Experimental | 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 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 | Active comparator | 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* 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Arm 1: Aerobics, Arm 2: Resistance training, Arm 3: Usual care |
| 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 | Arm 1: Aerobics, Arm 2: Resistance training, Arm 3: Usual care |
| 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 | Arm 1: Aerobics, Arm 2: Resistance training, Arm 3: Usual care |
| 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 | Arm 1: Aerobics, Arm 2: Resistance training, Arm 3: Usual care |
| Godin Leisure-Time Exercise Questionnaire (GLTEQ)-4 item query of usual leisure time exercise habits | Other | Arm 1: Aerobics, Arm 2: Resistance training, Arm 3: Usual care |
| Questionnaire regarding behavior/lifestyle changes since diagnosis | Other | Arm 1: Aerobics, Arm 2: Resistance training, Arm 3: Usual care |
| 12 week Walking Program | Other | Arm 1: Aerobics |
| 12 week Resistance Training Program | Other | Arm 2: Resistance training |
Primary outcome
Recruitment rate comparisons between physician referral and community advertisement
Time frame: Completion of study (approximately 3.5 years)
Attrition rate in each arm
Time frame: 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
Intervention effectiveness as measured by change in accelerometer measured physical activity
Time frame: 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)
Time frame: 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.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2016.
- Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of MedicineLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lin Yang, Ph.D. principal investigator
Washington University School of Medicine
Questions about this trial
What is this clinical trial studying?
A study testing Community Health Activities Model Program for Seniors (CHAMPS), Lifetime Total Physical Activity Questionnaire and Expanded Prostate Cancer Index Composite (EPIC) in people with Prostatectomy and Prostate Cancer, run by Washington University School of Medicine.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 29 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment rate comparisons between physician referral and community advertisement (time frame: Completion of study (approximately 3.5 years)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jan 2016.