Clinical trial · Interventional
Prostate Cancer - Patient Empowerment Program
Randomized Clinical Trial of an Early vs Late Patient Empowerment Program for Men Undergoing Curative Treatment for Prostate Cancer
- 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 study aims to educate and teach pre- (as opposed to most common post-) habilitation - preventive life habits aimed to empower men and address many of the issues faced by men undergoing radical prostatectomy or other active forms of prostate cancer treatments. The investigators hypothesize that daily text and email reminders, in addition to connecting men with other men undergoing similar challenges, will improve participant adherence to the pre-habilitation program. Secondary objectives will assess change in mental health, physical fitness, urological symptoms, state of relaxation, and quality of life parameters before and after the program.
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 |
|---|---|---|---|
| PC-PEP | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm A - Early Intervention
- description
- For 180 days participants in this arm will be exposed to the intervention and 180 days afterwards they will be exposed to the standard of care.
- interventionNames
- Behavioral: PC-PEP
- type
- ACTIVE_COMPARATOR
- label
- Arm B - Late Intervention
- description
- For 180 days participants in this arm will be exposed to the standard of care and 180 days afterwards they will be exposed to the intervention.
- interventionNames
- Behavioral: PC-PEP
Primary outcomes (1)
- measure
- Proportion of Participants With Clinically Significant Psychological Distress (Kessler Psychological Distress Scale-10 ≥20)
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * History of prostate cancer diagnosis * Non-metastatic stage at start of study * Approval from screening physician to participant in study * Existing (or willingness to create) email account * Ability to access and use daily email +/- text messages * Ability to understand and speak English language * Ability to participate in low to moderate levels of physical activity * Scheduled for a Radical Prostatectomy (RP) or curative intent Radiotherapy (RT)(external bean or bratty) or adjuvant or salvage RT post RP. Patient on Hormone therapy are eligible if they are scheduled to undergo RP or RT. * If deemed necessary by study physician, approval from family physician or oncologist to participate in the study Exclusion Criteria: * Unable to travel to Halifax for study visits (3 in total) * Unable to access the internet and lack of a computer/cellphone to receive emails required for study intervention * Patients being treated with Hormone therapy only * Patients on Active Surveillance * Patients deemed unfit to participate in low level exercise
References
Publications (2)
- DERIVEDPower B, Smith NK, Ilie G, Rendon RA, Mason R, Kokorovic A, MacDonald C, Patil N, Bowes D, Bailly G, Wilke D, Langley E, Rutledge R. Diet and Physical Activity as Mediators of Weight Loss in a Digital Prostate Cancer Survivorship Intervention for Men: Secondary Analysis of the PC-PEP Randomized Trial. Am J Mens Health. 2026 Jul-Aug;20(4):15579883261457532. doi: 10.1177/15579883261457532. Epub 2026 Aug 5. PMID 42552876
- DERIVEDBurgher C, Ilie G, Mason R, Rendon R, Kokorovic A, Bailly G, Patil N, Bowes D, Wilke D, MacDonald C, Tsirigotis M, Butler C, Bell D, Spooner J, Rutledge RDH. Assessing the Impact of the Prostate Cancer Patient Empowerment Program (PC-PEP) on Relationship Satisfaction, Quality of Life, and Support Group Participation: A Randomized Clinical Trial. Curr Oncol. 2024 Oct 21;31(10):6445-6474. doi: 10.3390/curroncol31100479. PMID 39451783