Clinical trial · Interventional
Predictors of Mental Health in Men With Prostate Cancer Undergoing a Patient Empowerment Program
PC-PEP Phase 4: Predictors of Mental Health in Men With Prostate Cancer Undergoing a Patient Empowerment Program
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Patient Empowerment Program | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Intervention Arm
- interventionNames
- Behavioral: Patient Empowerment Program
Primary outcomes (1)
- measure
- Mental Health
- timeFrame
- 6 - 24 months
- description
- Kessler 10 - assessment of psychological distress. Measured through on-line survey.
Secondary outcomes (10)
- measure
- General Health (Physical and Mental) Quality of Life as assessed by the 12-item Short Form Health Survey (SF-12)
- timeFrame
- 6 - 24 months
- description
- The scale has a score range of 0 to 100, with a higher score indicating a better outcome, and a score of 50 indicating the U.S. population average.
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Exclusion Criteria: * 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.
References
Publications (0)
Data not yet available