Prehabilitation for Prostate Cancer Surgery
Radical prostatectomy is the most common and effective treatment for localized prostate cancer. Unfortunately, radical prostatectomy is associated with significant adverse effects, such as urinary incontinence, sexual dysfunction, and reduced physical function that collectively diminish health-related quality of life which may persist for up to two years postoperatively. The primary objective of this trial is to assess the feasibility of conducting of a multi-site randomized controlled trial to test the effect of a comprehensive prehabilitation program versus standard care for men with prostate cancer undergoing radical prostatectomy. We hypothesize that men with prostate cancer undergoing radical prostatectomy in the comprehensive prehabilitation program (full-body exercises and pelvic floor muscle exercises) will report better health-related quality of life, urological symptoms, and physical fitness, physical activity, and pain, as well as a shorter postoperative length of stay than participants receiving standard preoperative care (pelvic floor muscle exercises alone). Our secondary objective is to report estimates of efficacy on several clinically important outcomes for this population that will be used for sample size calculations in an adequately powered trial.
Prostate Cancer Patients Undergoing Radical Prostatectomy
Behavioral: Prehabilitation (PREHAB)
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
|Official Title:||A Multicentre, Pilot Randomized Controlled Trial to Examine the Effects of Prehabilitation on Functional Outcomes After Radical Prostatectomy|
- Recruitment [ Time Frame: When recruitment is complete (approximately 12 months after study initiation; January 2015) ] [ Designated as safety issue: No ]Prior exercise trials in prostate cancer patients on hormone and/or radiation therapy have observed recruitment rates of 25-40%, but no studies have assessed recruitment to a preoperative exercise intervention among prostate cancer survivors. We will measure recruitment-success percentage and will record reasons for non-participation to better understand why men electing radical prostatectomy would not participate in an exercise intervention.
- Adherence to Prehabilitation Program [ Time Frame: 26 weeks postoperatively ] [ Designated as safety issue: No ]Adherence to the home-based exercise program (aerobic and resistance) and pelvic floor muscle exercises will be measured through a logbook completed by the research coordinator during weekly communication.
- Contamination [ Time Frame: 26 weeks postoperatively ] [ Designated as safety issue: No ]The same exercise logbook questions that ask about aerobic and resistance exercise, and pelvic floor muscle exercises, will be administered to both groups to assess contamination.
- Study Retention [ Time Frame: 26 weeks postoperatively ] [ Designated as safety issue: No ]Retention will be assessed by measuring attrition throughout the intervention period and at each assessment.
- Physical Fitness [ Time Frame: At baseline, within 1 week prior to surgery, and at 4, 12, and 26 weeks postoperatively. ] [ Designated as safety issue: No ]Musculoskeletal fitness will be assessed using grip strength (hand dynamometer) and maximal upper body strength (handheld digital dynamometer). Body composition will be assessed via body mass index, waist circumference (midpoint between lowest rib and iliac crest), and body fat percentage (bioelectrical impedance analysis). Aerobic fitness is measured using the 6-Minute Walk Test.
- Quality of Life [ Time Frame: At baseline, within 1 week prior to surgery, and at 4, 12, and 26 weeks postoperatively. ] [ Designated as safety issue: No ]Prostate cancer-specific health related quality of life (HRQOL) will be measured using the Functional Assessment of Cancer Treatment-Prostate (FACT-P) and the Patient-Oriented Prostate Utility Scale (PORPUS).
- Psychosocial Wellbeing [ Time Frame: At baseline, within 1 week prior to surgery, and at 4, 12, and 26 weeks postoperatively. ] [ Designated as safety issue: No ]Depressive symptoms will be measured with the 14-item Hospital Anxiety and Depression Scale (HADS). Cancer-specific fatigue will be measured using the FACT-Fatigue which is a widely used 13-item measure with strong reliability and validity. The Pain Disability Index (PDI) will be used to assess the extent to which persistent pain interferes with an individual's ability to engage in seven different areas of everyday activity.
- Physical Activity [ Time Frame: At baseline, within 1 week prior to surgery, and at 4, 12, and 26 weeks postoperatively. ] [ Designated as safety issue: No ]Physical activity level will be measured through the Community Health Activities Model Program for Seniors (CHAMPS) questionnaire. In-hospital and in-home physical activity during the acute postoperative period will be measured by the Actiwatch-64, a small wristwatch-like accelerometer device. The Actiwatch will be worn from admission to the in-patient unit until the patient returns to the hospital for catheter removal (approximately 7 days).
- Treatment Complications [ Time Frame: 26 weeks postoperatively ] [ Designated as safety issue: No ]The number and type of peri-operative complications will be extracted from medical records.
- Length of stay [ Time Frame: From time of surgery to discharge (typically 1 week) ] [ Designated as safety issue: No ]We will collect the postoperative length of stay information for all participants from the patient record.
|Study Start Date:||November 2013|
|Estimated Study Completion Date:||April 2015|
|Estimated Primary Completion Date:||April 2015 (Final data collection date for primary outcome measure)|
No Intervention: Healthy Lifestyle Booklet
Standard care for radical prostatectomy (RP) patients includes the provision of preoperative information from a urology nurse educator. Usual care (UC) participants will be given generic instructions by the research coordinator about pelvic floor muscle exercises (PFMX), mobilization and general timeframes for a return to normal activities. The UC group will receive the same PFMX prescription as the PREHAB (Experimental) group and will receive weekly communication from the research coordinator regarding compliance with the PFMX prescription to provide an attentional-control. These instructions are provided in a healthy lifestyle booklet for men with prostate cancer.
Experimental: Prehabilitation (PREHAB)
The prehabilitation (PREHAB) program focuses on total-body physical exercises and pelvic floor muscle exercises (PFMX). The total-body exercise prescription will consist of 60 minutes of home-based, unsupervised exercise on 3-4 days per week, alternating between aerobic and resistance training. Each session will include: a 5-minute warm-up, 25 minutes of aerobic exercise, 25 minutes of resistance training (5 exercises targeting major muscle groups), and a 5-minute cool-down. Training intensity progression will occur throughout the intervention. Participants will be provided with resistance bands, a stability ball, and an exercise mat. The PFMX prescription will include a gradual increase in PFMX exercises from 60 per day during weeks 1-2, 120 per day during weeks 3-4, and 180 per day during weeks 5-6 until the surgery date. The total number of repetitions of the PFMXs will be divided equally between the rhythmic and sustained contractions.
|Behavioral: Prehabilitation (PREHAB)|
Please refer to this study by its ClinicalTrials.gov identifier: NCT02036684
|Contact: Daniel Santa Mina, PhD||1(416)798-1331 ext firstname.lastname@example.org|
|Contact: Andrew G Matthew, PhD||1(416)email@example.com|
|University Health Network||Recruiting|
|Toronto, Ontario, Canada, M5G2C4|
|Contact: Daniel Santa Mina, Ph.D. 1(416)798-1331 ext 6065 firstname.lastname@example.org|
|Contact: Andrew G Matthew, Ph.D. C.Psych 1(416)946-2332 email@example.com|
|Principal Investigator: Daniel Santa Mina, Ph.D.|
|Principal Investigator: Andrew G Matthew, Ph.D. C.Psych|
|Sub-Investigator: Hance Clarke|
|Sub-Investigator: Paul Ritvo, Ph.D. C.Psych|
|Sub-Investigator: Antonio Finelli|
|Sub-Investigator: Leslie E Stefanyk, Ph.D.|
|Sub-Investigator: Franco Carli|
|Sub-Investigator: John Trachtenberg|
|Sub-Investigator: Neil Fleshner|
|Sub-Investigator: Shabbir M.H. Alibhai|
|McGill University Health Centre||Recruiting|
|Montreal, Quebec, Canada, H3G 1A4|
|Contact: Franco Carli, MD 1(519)934-1934 ext 43274 Franco.firstname.lastname@example.org|
|Contact: Sruthi Ramachandran email@example.com|
|Principal Investigator: Franco Carli, MD|