Continence, Sexual Function, Fitness and the Health of Men After Surgery for Prostate Cancer

Study Overview
=================
Brief 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 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. Determine the effects of the program on the primary outcome measure of urinary continence in comparison with usual care. Secondary objectives of this study To determine the effects of the program on cardiometabolic indicators in comparison with usual care. 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.

Official Title
-----------------
Continence, Sexual and Metabolic Health Programming to Promote Prostate Cancer Wellness for Life (CONTROL4LIFE)

Conditions
-----------------
Prostate Cancer, Incontinence, Metabolic Disease

Intervention / Treatment
-----------------
* Behavioral: Pelvic floor exercise program
* Behavioral: General exercise
* Behavioral: Physical Activity Counseling


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Zelen design with randomization
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>Pelvic floor exercise program and general exercise programming | Behavioral: Pelvic floor exercise program<br>* General exercises will be prescribed along with a specialized pelvic floor program<br>Behavioral: General exercise<br>* A general progressive resistance exercise program<br>|
| Active Comparator: Control<br>Pelvic floor exercises and standard care (physical activity counseling) | Behavioral: Pelvic floor exercise program<br>* General exercises will be prescribed along with a specialized pelvic floor program<br>Behavioral: Physical Activity Counseling<br>* Advice on increasing physical activity<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Completion Rate | The number of participants completing the study including all planned outcomes | Final assessment at one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recruitment rate | Percentage of participants who are eligible and agree to participate | One year | 
| Adherence rate | Adherence to the intervention components | Post-intervention: 12 weeks | 
| 24-hour pad test | Mean: Individual's urine loss by measuring weight (grams) of an absorbent pad | 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 | 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 | 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 | One-year | 
| Edmonton Symptom Assessment Scale | 11-item ordinal scale; Range 0-60; with higher scores indicating higher symptom burden | One year | 
| Self-efficacy Questionnaire: Incontinence | 6 item ordinal scale: Range 0-60; Higher scores indicating higher self-efficacy | One year | 
| Grip Strength | Dyanometer: mean in kgs | 12 weeks | 
| Lower body strength | Sit-to-stand: mean number completed in 30 seconds | 12-weeks | 
| Upper limb mobility | Shoulder Range of Motion: mean value in degrees | 12 weeks | 
| Flexibility | Sit and reach: mean value in cm | 12-weeks | 
| Balance | One-leg stance test: mean time in seconds | 12-weeks | 
| Walking endurance | Six-minute walk test: mean distance in metres | 12-weeks | 
| Body Mass Index | Height and weight will be combined to calculate BMI: mean: weight in kilograms divided by height in metres squared | 12-weeks | 
| Glucose | mmol/L (mean value) | 12-weeks | 
| Insulin level | mmol/L (mean value) | 12-weeks | 
| Lipid profile | Cholesterol level: mg/dL (mean value) | 12-weeks | 
| Hemoglobin A1c | Value in percentage (mean value) | 12-weeks |