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Trial Title:
Continence, Sexual Function, Fitness and the Health of Men After Surgery for Prostate Cancer
NCT ID:
NCT06072911
Condition:
Prostate Cancer
Incontinence
Metabolic Disease
Conditions: Official terms:
Prostatic Neoplasms
Metabolic Diseases
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Intervention model description:
Zelen design with randomization
Primary purpose:
Supportive Care
Masking:
Double (Participant, Outcomes Assessor)
Masking description:
The participants will be randomized after the baseline assessment and will have the
option to take part in an additional exercise intervention component.
Intervention:
Intervention type:
Behavioral
Intervention name:
Pelvic floor exercise program
Description:
General exercises will be prescribed along with a specialized pelvic floor program
Arm group label:
Control
Arm group label:
Intervention
Intervention type:
Behavioral
Intervention name:
General exercise
Description:
A general progressive resistance exercise program
Arm group label:
Intervention
Intervention type:
Behavioral
Intervention name:
Physical Activity Counseling
Description:
Advice on increasing physical activity
Arm group label:
Control
Summary:
The Continence, Sexual and Metabolic Health (CONTROL 4 LIFE) study will evaluate the
recovery of continence, sexual function, and health outcomes in individuals who have
undergone surgery for prostate cancer. The purpose of this study is to better understand
the timelines of recovery for these outcomes after surgery for prostate cancer. As part
of this study, all participants will receive resources offered by Alberta Health Services
regarding pre- and post-prostatectomy care, including information on pelvic floor
exercises. Through the CONTROL 4 LIFE study, the investigators will also be evaluating
outcomes related to physical activity, fitness and quality of life. These assessments
will enable the investigators to better understand how well and how long it takes for
individuals to recover after surgery for prostate cancer.
Detailed description:
The investigators aim to conduct a trial examining the feasibility and the effects of a
combined pelvic health rehabilitation and exercise program that can be delivered both
in-person and virtually in individuals who have been treated with prostatectomy for
prostate cancer. This hybrid format will support equitable program delivery regardless of
location of residence. To address issues faced by men with prostate cancer, the
investigators propose an intervention (offered virtually and in-person) that includes: 1)
online education to support continence, sexual and overall health; 2) a group exercise
fitness program that considers the needs and restrictions specific to the early
post-prostatectomy surgical period, and 3) functional and intensive pelvic floor muscle
exercise retraining to promote continence and sexual recovery.
Main objectives of this study
1. Determine the feasibility, defined as the acceptability and appropriateness, of a
combined pelvic health rehabilitation and exercise fitness program that can be
delivered both in-person and virtually.
2. Determine the effects of the program on the primary outcome measure of urinary
continence in comparison with usual care.
Secondary objectives of this study
1. To determine the effects of the program on cardiometabolic indicators in comparison
with usual care.
2. To determine the effects of the program on general fitness, secondary outcomes of
urinary continence, sexual function, self-efficacy, and cancer symptom burden, in
comparison with usual care.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- have a diagnosis of prostate cancer (stage I to IV);
- be scheduled for a prostatectomy surgery (any surgical approach);
- have no restriction to participate in at least mild levels of physical activity, as
confirmed by the Physical Activity Readiness Questionnaire (PAR-Q+);
- speak and understand English.
- adult: 18 years of age or older
- optional exercise component: willing and able to commit to the 12-week intervention
Exclusion Criteria:
- have any medical conditions that may interfere with continence (i.e. neurological
diseases);
- have any contraindications to exercise testing or training;
- have recent (>6 months) modifications to any medication aiming to reduce urinary
incontinence (i.e. Myrbetric);
- do not have regular access to the internet and a smart device or a computer at home/
at their community center;
- are already receiving a pelvic floor exercise program through a pelvic floor
physical therapist from their community.
Gender:
Male
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
University of Alberta
Address:
City:
Edmonton
Zip:
T6G 2G4
Country:
Canada
Status:
Recruiting
Contact:
Last name:
Margaret McNeely
Phone:
7802481531
Email:
mmcneely@ualberta.ca
Start date:
February 27, 2024
Completion date:
June 30, 2026
Lead sponsor:
Agency:
University of Alberta
Agency class:
Other
Source:
University of Alberta
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06072911
