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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
Secondary objectives of this study
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | Pelvic floor exercise program and general exercise programming |
|
| Control | Active Comparator | Pelvic floor exercises and standard care (physical activity counseling) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pelvic floor exercise program | Behavioral | General exercises will be prescribed along with a specialized pelvic floor program |
|
| Measure | Description | Time Frame |
|---|---|---|
| Completion Rate | The number of participants completing the study including all planned outcomes | Final assessment at one year |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Margaret L McNeely | Contact | 780-492-6007 | mmcneely@ualberta.ca | |
| Chris Sellar | Contact | 780-492-6007 | frmace@ualberta.ca |
| Name | Affiliation | Role |
|---|---|---|
| Nathan Hoy, MD | University of Alberta | Principal Investigator |
| Howard Evans, MD | University of Alberta | Principal Investigator |
| Margaret McNeely |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alberta | Recruiting | Edmonton | Alberta | T6G 2G4 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38431130 | Derived | 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.cct.2024.107482. Epub 2024 Feb 29. |
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Data will be housed on the University of Alberta's Dataverse
Following completion of the study and primary publication.
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| D008659 | Metabolic Diseases |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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Zelen design with randomization
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The participants will be randomized after the baseline assessment and will have the option to take part in an additional exercise intervention component.
| General exercise | Behavioral | A general progressive resistance exercise program |
|
| Physical Activity Counseling | Behavioral | Advice on increasing physical activity |
|
| 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 |
| University of Alberta |
| Principal Investigator |
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
| D009750 | Nutritional and Metabolic Diseases |