A program to help men with prostate cancer and their caregivers manage anxiety and health.
Official title: A SMART Design to Optimize the Delivery of TEMPO - a Tailored, wEb-based Psychosocial and Physical Activity Self-Management PrOgram for Men With Prostate Cancer and Their Caregivers
Run by St. Mary's Research Center, Canada · NCT06363266 · Data updated 2026-11-12
This study is testing a web-based program to help men with prostate cancer and their caregivers manage anxiety and improve their health on their own.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 376 (estimated) |
| Sponsor | St. Mary's Research Center, Canada Academic / other |
| Locations | 2 sites (Montreal, Canada and 1 other locations) |
| Status | Recruiting |
| Started | August 1, 2025 |
| Main results expected | October 31, 2026 |
| Study ends | August 31, 2028 |
| Registry record updated | June 11, 2026 |
| Trial ID | NCT06363266 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include men diagnosed with prostate cancer who are currently undergoing treatment and report moderate to high levels of anxiety.
✕Probably not a fit
Patients who are hospitalized or those who do not have a caregiver willing to participate may not benefit from this program.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study focuses on men diagnosed with prostate cancer and their caregivers, addressing the high levels of anxiety they experience due to the disease and its treatment. It utilizes TEMPO, a self-directed, web-based program designed to support both patients and caregivers in managing their physical and emotional health. The program emphasizes self-management strategies that can be implemented without direct healthcare professional guidance, making it accessible and sustainable. By combining psychosocial support with physical activity, TEMPO aims to enhance the overall well-being of both men with prostate cancer and their caregivers.
Why it matters
Potential benefit: If successful, this program could significantly reduce anxiety and improve the quality of life for men with prostate cancer and their caregivers.
How similar studies have gone: Other studies have shown promise in using self-management programs for cancer patients, indicating that this approach could be effective.
Who can join: the full rules
Show full inclusion / exclusion criteria
Patient inclusion criteria: Prostate cancer diagnosis; Treatment for prostate cancer (excluding active surveillance) scheduled to start or received within the past 2 years; Nominate a caregiver willing to participate; Report at least moderate anxiety (ESAS-r Anxiety 3+); Be able to read English or French; Have access to the internet Caregiver inclusion criteria: Are nominated by patient as primary support person; Are patients' spouse, partner, or other family member; If patient does not report moderate anxiety, caregiver needs to; Be able to read English or French; Have access to the internet Exclusion criteria for patient and caregiver: Hospitalized
Where it's running
-
St Mary's Hospital Research Centre
Montreal, Canada, Canada Recruiting -
St. Mary's Research Centre
Montreal, Quebec, Canada Recruiting
Study contacts
- Principal investigator: Sylvie Lambert, PhD — McGill University
- Study coordinator: Sylvie Lambert, PhD
- Email: sylvie.lambert@mcgill.ca
- Phone: 514-398-3685
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.