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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Enrollment
106
General exercises will be prescribed along with a specialized pelvic floor program
A general progressive resistance exercise program
Advice on increasing physical activity
University of Alberta
Edmonton, Alberta, Canada
RECRUITINGCompletion Rate
The number of participants completing the study including all planned outcomes
Time frame: Final assessment at one year
Recruitment rate
Percentage of participants who are eligible and agree to participate
Time frame: One year
Adherence rate
Adherence to the intervention components
Time frame: Post-intervention: 12 weeks
24-hour pad test
Mean: Individual's urine loss by measuring weight (grams) of an absorbent pad
Time frame: 24 hours at two time points: immediate post surgery and 12 weeks
Expanded Prostate Cancer Index Composite for Clinical Practice
16-questions: urinary function, sexual and erectile function, bowel and hormonal function; Scores: 0 (no symptoms) to 60 (most severe symptoms); Higher scores indicate worse functioning
Time frame: One-year
International Consultation on Incontinence Questionnaire
13 questions: occurrence and bother of lower urinary tract symptoms, quality of life; Range of scores: 0-20 voiding subscale; 0-20 incontinence symptoms; Higher scores indicate worse functioning
Time frame: One-year
36-Item Short Form Survey
Quality of life measure: Items are scored 0-100 (percentage of total possible score): Higher scores equal better quality of life
Time frame: One-year
Edmonton Symptom Assessment Scale
11-item ordinal scale; Range 0-60; with higher scores indicating higher symptom burden
Time frame: One year
Self-efficacy Questionnaire: Incontinence
6 item ordinal scale: Range 0-60; Higher scores indicating higher self-efficacy
Time frame: One year
Grip Strength
Dyanometer: mean in kgs
Time frame: 12 weeks
Lower body strength
Sit-to-stand: mean number completed in 30 seconds
Time frame: 12-weeks
Upper limb mobility
Shoulder Range of Motion: mean value in degrees
Time frame: 12 weeks
Flexibility
Sit and reach: mean value in cm
Time frame: 12-weeks
Balance
One-leg stance test: mean time in seconds
Time frame: 12-weeks
Walking endurance
Six-minute walk test: mean distance in metres
Time frame: 12-weeks
Body Mass Index
Height and weight will be combined to calculate BMI: mean: weight in kilograms divided by height in metres squared
Time frame: 12-weeks
Glucose
mmol/L (mean value)
Time frame: 12-weeks
Insulin level
mmol/L (mean value)
Time frame: 12-weeks
Lipid profile
Cholesterol level: mg/dL (mean value)
Time frame: 12-weeks
Hemoglobin A1c
Value in percentage (mean value)
Time frame: 12-weeks
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