NCT06363266 A SMART Design to Optimize the Delivery of TEMPO for Men With Prostate Cancer and Their Caregivers
| NCT ID | NCT06363266 |
| Status | Recruiting |
| Phase | — |
| Sponsor | St. Mary's Research Center, Canada |
| Condition | Cancer of the Prostate |
| Study Type | INTERVENTIONAL |
| Enrollment | 376 participants |
| Start Date | 2025-08-01 |
| Primary Completion | 2026-10-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 376 participants in total. It began in 2025-08-01 with a primary completion date of 2026-10-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Men with prostate cancer and their family caregivers face many physical and emotional challenges from the cancer itself and its treatment(s), which often lead to high anxiety. The pandemic has highlighted the importance of protecting our physical and mental health, and the complex responsibilities that caregivers have in supporting their loved ones. To improve the health of men with prostate cancer and of their caregivers, the research team developed TEMPO: a self-directed Tailored, wEb-based, psychosocial and physical activity self-Management PrOgram. TEMPO was developed with men with prostate cancer and their caregivers over the past 8 years. It also combines the investigators' research conducted over the past decade on providing the best support to those affected by cancer. Because the cancer care workforce is already overstretched, the research team designed TEMPO to be used without guidance from a health care professional. TEMPO is one-of-a kind in its support of both patients and caregivers, and the integration of coping skills training on a wide range of cancer challenges along with a home-based exercise program. Patients and caregivers who have used TEMPO said they improved their communication, learned new skills to cope with both physical and emotional challenges of cancer, and increased their physical activity. The present project builds on this work to further evaluate the cost and impact of TEMPO on men's and caregivers' health. Men with prostate cancer and their caregivers will be assigned by chance to one of two groups a) TEMPO or b) monitor their anxiety for 12 weeks. After 12 weeks, patients' and caregivers' needing more support will be identified based on an assessment of their anxiety level. For those already using TEMPO and needing more support, non-health care professional guidance might be offered. All those in the monitoring group needing more support will now have access to TEMPO. All participants complete surveys to determine whether TEMPO led to improved health outcomes.
Eligibility 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
Contact & Investigator
Sylvie Lambert, PhD
PRINCIPAL INVESTIGATOR
McGill University
Frequently Asked Questions
Who can join the NCT06363266 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Cancer of the Prostate. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06363266 currently recruiting?
Yes, NCT06363266 is actively recruiting participants. Contact the research team at sylvie.lambert@mcgill.ca for enrollment information.
Where is the NCT06363266 trial being conducted?
This trial is being conducted at Montreal, Canada, Montreal, Canada.
Who is sponsoring the NCT06363266 clinical trial?
NCT06363266 is sponsored by St. Mary's Research Center, Canada. The principal investigator is Sylvie Lambert, PhD at McGill University. The trial plans to enroll 376 participants.
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