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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
86
University Health Network
Toronto, Ontario, Canada
McGill University Health Centre
Montreal, Quebec, Canada
Recruitment
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.
Time frame: When recruitment is complete (approximately 12 months after study initiation; January 2015)
Adherence to Prehabilitation Program
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.
Time frame: 26 weeks postoperatively
Contamination
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.
Time frame: 26 weeks postoperatively
Study Retention
Retention will be assessed by measuring attrition throughout the intervention period and at each assessment.
Time frame: 26 weeks postoperatively
Physical Fitness
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.
Time frame: At baseline, within 1 week prior to surgery, and at 4, 12, and 26 weeks postoperatively.
Quality of Life
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).
Time frame: At baseline, within 1 week prior to surgery, and at 4, 12, and 26 weeks postoperatively.
Psychosocial Wellbeing
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.
Time frame: At baseline, within 1 week prior to surgery, and at 4, 12, and 26 weeks postoperatively.
Physical Activity
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).
Time frame: At baseline, within 1 week prior to surgery, and at 4, 12, and 26 weeks postoperatively.
Treatment Complications
The number and type of peri-operative complications will be extracted from medical records.
Time frame: 26 weeks postoperatively
Length of stay
We will collect the postoperative length of stay information for all participants from the patient record.
Time frame: From time of surgery to discharge (typically 1 week)
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