A program to help men with prostate cancer and their caregivers manage anxiety and health.
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
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 376 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | St. Mary's Research Center, Canada Academic / other |
| Locations | 2 sites (Montreal, Canada and 1 other locations) |
| Trial ID | NCT06363266 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include men diagnosed with prostate cancer who are currently undergoing treatment and report moderate to high levels of anxiety.
Not a fit: Patients who are hospitalized or those who do not have a caregiver willing to participate may not benefit from this program.
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 performed: Other studies have shown promise in using self-management programs for cancer patients, indicating that this approach could be effective.
Eligibility criteria
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 this trial is running
Montreal, Canada and 1 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.