A SMART Design to Optimize the Delivery of TEMPO for Men With Prostate Cancer and Their Caregivers
Launched by ST. MARY'S RESEARCH CENTER, CANADA · Apr 9, 2024
Trial Information
Current as of June 26, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is studying a program called TEMPO, designed to help men with prostate cancer and their caregivers manage both the physical and emotional challenges that come with the disease. Prostate cancer and its treatments can lead to high levels of anxiety for both patients and their caregivers, and TEMPO aims to provide support through online resources. The program includes coping skills training and a home-based exercise plan, making it easy for participants to use without needing a healthcare professional's guidance.
To be eligible for the trial, men must have a diagnosis of prostate cancer and be receiving treatment (with certain exceptions) while also reporting moderate to high anxiety. They must also have a caregiver willing to participate, who is typically a spouse, partner, or family member. Participants will be randomly assigned to either use the TEMPO program or to just monitor their anxiety for 12 weeks. After this period, those needing extra support will have the chance to access TEMPO. Throughout the trial, all participants will complete surveys to help researchers understand how well TEMPO improves their health and well-being.
Gender
ALL
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
About St. Mary's Research Center, Canada
St. Mary's Research Center, located in Canada, is a leading institution dedicated to advancing medical research and improving patient care through innovative clinical trials. Committed to fostering collaboration among healthcare professionals, researchers, and industry partners, the center focuses on a diverse range of therapeutic areas, including cardiology, neurology, and oncology. With a robust infrastructure and a patient-centered approach, St. Mary's Research Center aims to translate scientific discoveries into practical applications, enhancing treatment outcomes and contributing to the overall health of the community.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Montréal, , Canada
Montreal, Quebec, Canada
Patients applied
Trial Officials
Sylvie Lambert, PhD
Principal Investigator
McGill University
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported