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)

Overview

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.

Interventions

• 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
• Behavioral Physical Activity Counseling
  Advice on increasing physical activity

Primary outcome measures

• Completion Rate [Time frame: Final assessment at one year]

Secondary outcome measures (12)

• Recruitment rate [Time frame: One year]
• Adherence rate [Time frame: Post-intervention: 12 weeks]
• 24-hour pad test [Time frame: 24 hours at two time points: immediate post surgery and 12 weeks]
• Expanded Prostate Cancer Index Composite for Clinical Practice [Time frame: One-year]
• International Consultation on Incontinence Questionnaire [Time frame: One-year]
• 36-Item Short Form Survey [Time frame: One-year]
• Edmonton Symptom Assessment Scale [Time frame: One year]
• Self-efficacy Questionnaire: Incontinence [Time frame: One year]
• Grip Strength [Time frame: 12 weeks]
• Lower body strength [Time frame: 12-weeks]
• Upper limb mobility [Time frame: 12 weeks]
• Flexibility [Time frame: 12-weeks]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Double blind

Primary purpose

Supportive care

Study locations

Canada · 1 center

• University of Alberta — Edmonton

Publications

• Bernard S, Evans H, Hoy NY, Suderman K, Cameron B, Sexsmith J, Kinnaird A, Rourke K, Dean L, Pituskin E, Usmani N, Tandon P, McNeely ML. Control4Life: A randomized controlled trial protocol examining the feasibility and efficacy of a combined pelvic health rehabilitation and exercise fitness program for individuals undergoing prostatectomy. Contemp Clin Trials. 2024 Apr;139:107482. doi: 10.1016/j. PMID 38431130

Identifiers

NCT: NCT06072911 · HREBA.CC-23-0207

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗