Prehabilitation for Prostate Cancer Surgery

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by University of Guelph-Humber
Sponsor:
Collaborators:
University Health Network, Toronto
Princess Margaret Hospital, Canada
McGill University Health Center
Information provided by (Responsible Party):
Daniel Santa Mina, University of Guelph-Humber
ClinicalTrials.gov Identifier:
NCT02036684
First received: November 16, 2013
Last updated: April 14, 2014
Last verified: April 2014
  Purpose

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.


Condition Intervention Phase
Prostate Cancer Patients Undergoing Radical Prostatectomy
Behavioral: Prehabilitation (PREHAB)
Phase 1
Phase 2

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by University of Guelph-Humber:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 100
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)
Arms Assigned Interventions
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 20 per day during weeks 1-2, 60 per day during weeks 3-4, and 100 per day during weeks 5-6. The total number of repetitions of the PFMXs will be divided equally between the rhythmic and sustained contractions.
Behavioral: Prehabilitation (PREHAB)

  Eligibility

Ages Eligible for Study:   45 Years to 85 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Men with localized prostate cancer (stage cT1- cT2) who have consented for radical prostatectomy
  • between the ages of 45 and 85 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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02036684

Contacts
Contact: Daniel Santa Mina, PhD 1(416)798-1331 ext 6065 daniel.santamina@guelphhumber.ca
Contact: Andrew G Matthew, PhD 1(416)946-2332 andrew.matthew@uhn.ca

Locations
Canada, Ontario
University Health Network Recruiting
Toronto, Ontario, Canada, M5G2C4
Contact: Daniel Santa Mina, Ph.D.    1(416)798-1331 ext 6065    daniel.santamina@guelphhumber.ca   
Contact: Andrew G Matthew, Ph.D. C.Psych    1(416)946-2332    andrew.matthew@uhn.ca   
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         
Canada, Quebec
McGill University Health Centre Not yet recruiting
Montreal, Quebec, Canada, H3G 1A4
Contact: Franco Carli, MD    1(519)934-1934 ext 43274    Franco.carli@mcgill.ca   
Contact: Sruthi Ramachandran       shruthir81@gmail.com   
Principal Investigator: Franco Carli, MD         
Sponsors and Collaborators
University of Guelph-Humber
University Health Network, Toronto
Princess Margaret Hospital, Canada
McGill University Health Center
  More Information

No publications provided

Responsible Party: Daniel Santa Mina, Assistant Program Head, University of Guelph-Humber
ClinicalTrials.gov Identifier: NCT02036684     History of Changes
Other Study ID Numbers: D-201327
Study First Received: November 16, 2013
Last Updated: April 14, 2014
Health Authority: Canada: Health Canada

Keywords provided by University of Guelph-Humber:
Prostate cancer
Radical prostatectomy
Prehabilitation
Pelvic floor muscle exercises

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases

ClinicalTrials.gov processed this record on July 31, 2014