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Completed

NCT Number: NCT02036684

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.

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Key information

Conditions

Prostate Cancer Patients Undergoing Radical Prostatectomy Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

40 year–80 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

University Health Network, Toronto, Ontario, Canada

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Prehabilitation (PREHAB)

Behavioral

Primary outcomes

  1. Recruitment

    Time frame: When recruitment is complete (approximately 12 months after study initiation; January 2015)

    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.

  2. Adherence to Prehabilitation Program

    Time frame: 26 weeks postoperatively

    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.

  3. Contamination

    Time frame: 26 weeks postoperatively

    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.

  4. Study Retention

    Time frame: 26 weeks postoperatively

    Retention will be assessed by measuring attrition throughout the intervention period and at each assessment.

Secondary outcomes

  1. Physical Fitness

    Time frame: At baseline, within 1 week prior to surgery, and at 4, 12, and 26 weeks postoperatively.

    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.

  2. Quality of Life

    Time frame: At baseline, within 1 week prior to surgery, and at 4, 12, and 26 weeks postoperatively.

    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).

  3. Psychosocial Wellbeing

    Time frame: At baseline, within 1 week prior to surgery, and at 4, 12, and 26 weeks postoperatively.

    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.

  4. Physical Activity

    Time frame: At baseline, within 1 week prior to surgery, and at 4, 12, and 26 weeks postoperatively.

    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).

  5. Treatment Complications

    Time frame: 26 weeks postoperatively

    The number and type of peri-operative complications will be extracted from medical records.

  6. Length of stay

    Time frame: From time of surgery to discharge (typically 1 week)

    We will collect the postoperative length of stay information for all participants from the patient record.

Sponsors and collaborators

Lead sponsor

University of Guelph-Humber

Other

Collaborators

  • McGill University Health Centre/Research Institute of the McGill University Health Centre
  • Princess Margaret Hospital, Canada
  • University Health Network, Toronto

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Jan 15, 2014
Registry last updated
Aug 23, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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