Continence, Sexual Function, Fitness and the Health of Men After Surgery for Prostate Cancer (CONTROL4LIFE)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Prostate Cancer; Metabolic Disease; Incontinence
• Intervention / Treatment: Behavioral: Pelvic floor exercise program; Behavioral: General exercise; Behavioral: Physical Activity Counseling

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.

• Study Type: Interventional
• Enrollment (Estimated): 106
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Margaret L McNeely; Phone Number: 780-492-6007; Email: mmcneely@ualberta.ca
• Study Contact Backup: Name: Chris Sellar; Phone Number: 780-492-6007; Email: frmace@ualberta.ca

Study Locations

• Canada
  • Alberta
    • Edmonton, Alberta, Canada, T6G 2G4
      • Recruiting
      • University of Alberta
      • Contact: Margaret McNeely; Phone Number: 7802481531; Email: mmcneely@ualberta.ca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

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

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

Collaborators and Investigators

• Sponsor: University of Alberta
• Investigators: Principal Investigator: Nathan Hoy, MD, University of Alberta; Principal Investigator: Howard Evans, MD, University of Alberta; Principal Investigator: Margaret McNeely, University of Alberta

Study record dates

Study Major Dates

• Study Start (Actual): February 27, 2024
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): June 30, 2026

Study Registration Dates

• First Submitted: September 12, 2023
• First Submitted That Met QC Criteria: October 2, 2023
• First Posted (Actual): October 10, 2023

Study Record Updates

• Last Update Posted (Actual): February 29, 2024
• Last Update Submitted That Met QC Criteria: February 27, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Urogenital Diseases; Male Urogenital Diseases; Genital Diseases, Male; Genital Diseases; Prostatic Neoplasms; Metabolic Diseases
• Other Study ID Numbers: HREBA.CC-23-0207

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Data will be housed on the University of Alberta's Dataverse
• IPD Sharing Time Frame: Following completion of the study and primary publication.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No