Prehabilitation for Prostate Cancer Surgery

Prostate Cancer Patients Undergoing Radical Prostatectomy Clinical Trial

Official title:

A Multicentre, Pilot Randomized Controlled Trial to Examine the Effects of Prehabilitation on Functional Outcomes After Radical Prostatectomy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02036684
• Other study ID #: D-201327
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: November 16, 2013
• Last updated: August 22, 2017
• Start date: November 2013
• Est. completion date: May 17, 2016

Study information

• Verified date: August 2017
• Source: University of Guelph-Humber
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 86
• Est. completion date: May 17, 2016
• Est. primary completion date: May 17, 2016
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 40 Years to 80 Years

Eligibility

Inclusion Criteria:

• Men with localized prostate cancer (stage cT1- cT2) who have consented for radical prostatectomy

• between the ages of 40 and 80 years.

Exclusion Criteria:

• i) severe coronary artery disease (Canadian Cardiovascular Society class III or greater);

• ii) significant congestive heart failure (New York Heart Association class III or greater);

• iii) uncontrolled pain;

• iv) neurological or musculoskeletal co-morbidity inhibiting exercise;

• v) diagnosed psychotic, addictive, or major cognitive disorders;

• vi) no more than two of the following Coronary Risk Factors as defined by the American College of Sports Medicine : family history of coronary disease, cigarette smoking, hypertension (SBP > 140 mmHg; DBP > 90 mmHg), known dyslipidemia, known impaired fasting, glucose (>110 mg/dL), obesity (BMI > 30 kg/m2 or waist circumference > 102cm), or physically inactive (<150 min of moderate intensity physical activity per week).

Related Conditions & MeSH terms

• Prostate Cancer Patients Undergoing Radical Prostatectomy
• Prostatic Neoplasms

Intervention

Behavioral:
• Prehabilitation (PREHAB)

Locations

Country	Name	City	State
Canada	McGill University Health Centre	Montreal	Quebec
Canada	University Health Network	Toronto	Ontario

Sponsors (4)

Lead Sponsor	Collaborator
University of Guelph-Humber	McGill University Health Center, Princess Margaret Hospital, Canada, University Health Network, Toronto

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	When recruitment is complete (approximately 12 months after study initiation; January 2015)
Primary	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.	26 weeks postoperatively
Primary	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.	26 weeks postoperatively
Primary	Study Retention	Retention will be assessed by measuring attrition throughout the intervention period and at each assessment.	26 weeks postoperatively
Secondary	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.	At baseline, within 1 week prior to surgery, and at 4, 12, and 26 weeks postoperatively.
Secondary	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).	At baseline, within 1 week prior to surgery, and at 4, 12, and 26 weeks postoperatively.
Secondary	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.	At baseline, within 1 week prior to surgery, and at 4, 12, and 26 weeks postoperatively.
Secondary	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).	At baseline, within 1 week prior to surgery, and at 4, 12, and 26 weeks postoperatively.
Secondary	Treatment Complications	The number and type of peri-operative complications will be extracted from medical records.	26 weeks postoperatively
Secondary	Length of stay	We will collect the postoperative length of stay information for all participants from the patient record.	From time of surgery to discharge (typically 1 week)