nctId: NCT06363266 id: 190211_1 briefTitle: A SMART Design to Optimize the Delivery of TEMPO for Men With Prostate Cancer and Their Caregivers overallStatus: NOT_YET_RECRUITING date: 2024-09-01 date: 2026-08-31 date: 2028-08-31 date: 2024-04-12 date: 2024-04-12 name: St. Mary's Research Center, Canada class: OTHER name: Princess Margaret Hospital, Canada name: University of Calgary name: Sunnybrook Health Sciences Centre name: University of British Columbia name: McGill University name: Simon Fraser University name: Université de Sherbrooke name: Memorial University of Newfoundland name: Université de Montréal name: Centre intégré de santé et de services sociaux (CISSS) de Laval briefSummary: 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. conditions: Cancer of the Prostate conditions: Anxiety studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: SEQUENTIAL interventionModelDescription: Using a stepped care approach, TEMPO will be provided across two intervention stages with variations on timing (initial vs. delayed) and intensity (self-directed vs. guided). All dyads will continue to access usual care (a co-intervention measure is included). primaryPurpose: SUPPORTIVE_CARE masking: DOUBLE whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 376 type: ESTIMATED name: TEMPO name: Active Monitoring dyads' anxiety measure: HADS-Anxiety measure: TEMPO's key mechanisms of action sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: St. Mary's Research Centre city: Montreal state: Quebec zip: H3T1M5 country: Canada name: Sylvie Lambert, PhD role: CONTACT phone: 514-398-3685 email: sylvie.lambert@mcgill.ca lat: 45.50884 lon: -73.58781 facility: St Mary's Hospital Research Centre city: Montréal country: Canada name: Manon de Raad role: CONTACT email: manon.deraad@ssss.gouv.qc.ca lat: 45.50884 lon: -73.58781 hasResults: False