Clinical trial NCT06072911: Continence, Sexual Function, Fitness and the Health of Men After Surgery for Prostate Cancer
Official title: Continence, Sexual and Metabolic Health Programming to Promote Prostate Cancer Wellness for Life (CONTROL4LIFE)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Prostate Cancer
Incontinence
Metabolic Disease
Lead sponsor: University of Alberta
Sponsor class: OTHER
First posted: 2023-10-10
Enrollment: 106
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Zelen design with randomization
Primary purpose: SUPPORTIVE_CARE

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

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.

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.

Primary outcomes:
measure: Completion Rate
timeFrame: Final assessment at one year
Secondary outcomes:
measure: Recruitment rate
timeFrame: One year
measure: Adherence rate
timeFrame: Post-intervention: 12 weeks
measure: 24-hour pad test
timeFrame: 24 hours at two time points: immediate post surgery and 12 weeks
measure: Expanded Prostate Cancer Index Composite for Clinical Practice
timeFrame: One-year
measure: International Consultation on Incontinence Questionnaire
timeFrame: One-year
measure: 36-Item Short Form Survey
timeFrame: One-year
measure: Edmonton Symptom Assessment Scale
timeFrame: One year
measure: Self-efficacy Questionnaire: Incontinence
timeFrame: One year
measure: Grip Strength
timeFrame: 12 weeks
measure: Lower body strength
timeFrame: 12-weeks
measure: Upper limb mobility
timeFrame: 12 weeks
measure: Flexibility
timeFrame: 12-weeks
measure: Balance
timeFrame: 12-weeks
measure: Walking endurance
timeFrame: 12-weeks
measure: Body Mass Index
timeFrame: 12-weeks
measure: Glucose
timeFrame: 12-weeks
measure: Insulin level
timeFrame: 12-weeks
measure: Lipid profile
timeFrame: 12-weeks
measure: Hemoglobin A1c
timeFrame: 12-weeks
Other outcomes:
Locations:
city: Edmonton
country: Canada
facility: University of Alberta
state: Alberta
Study officials:
affiliation: University of Alberta
name: Nathan Hoy, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Alberta
name: Howard Evans, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Alberta
name: Margaret McNeely
role: PRINCIPAL_INVESTIGATOR
References: