protocolSection identificationModule nctId: NCT06363266, orgStudyIdInfo id: 190211_1, briefTitle: A SMART Design to Optimize the Delivery of TEMPO for Men With Prostate Cancer and Their Caregivers, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-09-01, primaryCompletionDateStruct date: 2026-08-31, completionDateStruct date: 2028-08-31, studyFirstPostDateStruct date: 2024-04-12, lastUpdatePostDateStruct date: 2024-04-12, sponsorCollaboratorsModule leadSponsor name: St. Mary's Research Center, Canada, class: OTHER, collaborators name: Princess Margaret Hospital, Canada, collaborators name: University of Calgary, collaborators name: Sunnybrook Health Sciences Centre, collaborators name: University of British Columbia, collaborators name: McGill University, collaborators name: Simon Fraser University, collaborators name: Université de Sherbrooke, collaborators name: Memorial University of Newfoundland, collaborators name: Université de Montréal, collaborators name: Centre intégré de santé et de services sociaux (CISSS) de Laval, descriptionModule 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., conditionsModule conditions: Cancer of the Prostate, conditions: Anxiety, designModule studyType: INTERVENTIONAL, phases: NA, designInfo 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, maskingInfo masking: DOUBLE, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 376, type: ESTIMATED, armsInterventionsModule interventions name: TEMPO, interventions name: Active Monitoring dyads' anxiety, outcomesModule primaryOutcomes measure: HADS-Anxiety, secondaryOutcomes measure: TEMPO's key mechanisms of action, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: St. Mary's Research Centre, city: Montreal, state: Quebec, zip: H3T1M5, country: Canada, contacts name: Sylvie Lambert, PhD, role: CONTACT, phone: 514-398-3685, email: sylvie.lambert@mcgill.ca, geoPoint lat: 45.50884, lon: -73.58781, locations facility: St Mary's Hospital Research Centre, city: Montréal, country: Canada, contacts name: Manon de Raad, role: CONTACT, email: manon.deraad@ssss.gouv.qc.ca, geoPoint lat: 45.50884, lon: -73.58781, hasResults: False