A SMART Design to Optimize the Delivery of TEMPO for Men With Prostate Cancer and Their Caregivers

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.

NCT Number	NCT06363266
Lead Sponsor	St. Mary's Research Center, Canada Collaborators: Princess Margaret Hospital, Canada, University of Calgary, Sunnybrook Health Sciences Centre, University of British Columbia, McGill University, Simon Fraser University, Université de Sherbrooke, Memorial University of Newfoundland, Université de Montréal, CISSS de Laval
Conditions	Cancer of the Prostate, Anxiety
Enrollment	376 participants
Start Date	2025-08-01
Primary Completion	2026-10-31 (estimated)
Study Completion	2028-08-31 (estimated)
Updated on ClinicalTrials.gov	2026-06-11