Predictors of Mental Health in Men With Prostate Cancer Undergoing a Patient Empowerment Program
PC-PEP
PC-PEP Phase 4: Predictors of Mental Health in Men With Prostate Cancer Undergoing a Patient Empowerment Program
1 other identifier
interventional
2,130
5 countries
16
Brief Summary
Each year over 20,000 men are diagnosed with prostate cancer in Canada with the majority undergoing some form of treatment option. Radical prostatectomy and/or radiation therapy are common procedures that are effective in the treatment of prostate cancer. However, they typically incur both short- and long-term side effects (e.g. urinary incontinence, sexual dysfunction, reduced physical function, etc) that can negatively impact one's quality of life. This program of research aims to address the most critical needs of PC survivors: the development and evaluation of interventions to address the quality of life impact of PC. This study will test the Prostate Cancer Patient Empowerment Program (PC-PEP) in 400 men, a comprehensive intervention aimed at educating and teaching the men life skills/habits in order to improve their mental health issues, fitness levels and overall quality of life, and to decrease treatment related side effects. The program also aims to improve the overall health of the participants in the long term.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable prostate-cancer
Started Sep 2021
Longer than P75 for not_applicable prostate-cancer
16 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 13, 2021
CompletedFirst Posted
Study publicly available on registry
May 20, 2021
CompletedStudy Start
First participant enrolled
September 29, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2030
ExpectedStudy Completion
Last participant's last visit for all outcomes
October 1, 2031
March 18, 2026
March 1, 2026
8.5 years
May 13, 2021
March 16, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Mental Health
Kessler 10 - assessment of psychological distress. Measured through on-line survey.
6 - 24 months
Secondary Outcomes (10)
General Health (Physical and Mental) Quality of Life as assessed by the 12-item Short Form Health Survey (SF-12)
6 - 24 months
Disease Specific Health-Related Quality of Life as assessed by the Functional Assessment of Cancer Therapy-Prostate (FACT-P)
6 - 24 months
Urinary, Bowel, Hormonal, and Sexual Function as assessed by the Expanded Prostate Cancer Index Composite (EPIC)
6 - 24 months
Urinary Bother as assessed by the International Prostate Symptom Score (IPSS)
6 - 24 months
Health Care Utilization
6 - 24 months
- +5 more secondary outcomes
Study Arms (1)
Intervention Arm
EXPERIMENTALInterventions
The 6 months "at home" program focuses on aerobic and strength training, pelvic floor muscle exercises, meditation, social connection, and overall healthy lifestyle practices supported with daily text message/email reminders. The aerobic (5 times/week) and strength (2 times/week) program will comprise of a single 30-minute session daily and will be individualized to each participant. Pelvic floor muscle training will include three, 10-minute sessions and mediation for 10 minutes daily. Intimacy and Connection component of PC-PEP consists of engaging in at least one form of intimacy practice prescribed, per day. Social connection will be fostered by pairing participants up with peers from the study. To encourage program compliance, study participants will receive 3 daily reminders to do their pelvic floor muscle exercises per day plus an additional motivational email daily containing helpful tips.
Eligibility Criteria
You may qualify if:
- Age \>18
- History of a prostate cancer diagnosis
- Safe to exercise and do strength training (participants who have recovered from a minor stroke or heart condition in the past will require approval from their Family Physician or Cardiologist to participate in the study. Participants with advanced prostate cancer will need approval from the Study Physician or their Urologist or Oncologist to participate)
- Existing (or willingness to create) email account
- Willingness to access and use daily email and/or text messages
- Ability to follow website links to watch YouTube videos
- Ability to understand and speak English
- Ability to participate in low to moderate levels of physical activity
- Ability and willingness to fill out an online survey at baseline, and 6, 12 and 24 months, and a weekly compliance survey for the six months of the program.
- Deemed to have an expected survival greater than 2 years
You may not qualify if:
- Patients deemed unfit to participate in low level exercise eg. including but not limited to a myocardial infarction or stroke within the last year, without approval from their Family Physician or Cardiologist that they are safe to exercise.
- Unable to access the internet and lack of a computer or cellphone to receive emails required for study intervention, or unable to click on a link to successfully watch a YouTube video.
- Men with a predicted survival less than 2 years.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Gabriela Ilielead
- Dalhousie Universitycollaborator
Study Sites (16)
University Hospital Ghent
Ghent, East Flanders, 9000, Belgium
Dianne and Irving Kipnes Urology Centre
Edmonton, Alberta, T6G 1Z1, Canada
BC Cancer - Kelowna (Sindi Ahluwalia Hawkins Centre)
Kelowna, British Columbia, V1Y 5L3, Canada
Men's Health Clinic Manitoba
Winnipeg, Manitoba, R3K 1M3, Canada
Saint John Regional Hospital
Saint John, New Brunswick, E2L 4L4, Canada
Health Sciences Centre
St. John's, Newfoundland and Labrador, A1B 3V6, Canada
QEII Health Sciences Centre
Halifax, Nova Scotia, B3H 2Y9, Canada
Mount Sinai Hospital
Toronto, Ontario, M5G 1X5, Canada
Whitby Health Centre - Dr. Ernest Chan Medicine Professional Corporation
Whitby, Ontario, L1P 0P9, Canada
Queen Elizabeth Hospital
Charlottetown, Prince Edward Island, C1A 8T5, Canada
Hôpital de l'Enfant-Jésus
Québec, Quebec, G1J 1Z4, Canada
Saskatoon Health Authority
Saskatoon, Saskatchewan, S7M 2W2, Canada
Prostate Cancer Foundation of New Zealand
Auckland, 0632, New Zealand
Medisprof Cancer Center
Cluj-Napoca, Transylvania, 400124, Romania
Sefako Makgatho Health University
Ga-Rankuwa, Gauteng, 2193, South Africa
Charlotte Maxeke Johannesburg Academic Hospital
Johannesburg, Gauteng, 2193, South Africa
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Affiliate Scientist (Associate Professor, Dalhousie University)
Study Record Dates
First Submitted
May 13, 2021
First Posted
May 20, 2021
Study Start
September 29, 2021
Primary Completion (Estimated)
April 1, 2030
Study Completion (Estimated)
October 1, 2031
Last Updated
March 18, 2026
Record last verified: 2026-03