A SMART Design to Optimize the Delivery of TEMPO - a Tailored, wEb-based Psychosocial and Physical Activity Self-Management PrOgram for Men With Prostate Cancer and Their Caregivers

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Other, Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
Locations
Other Locations
Canada
St Mary's Hospital Research Centre
RECRUITING
Montreal
St. Mary's Research Centre
RECRUITING
Montreal
Contact Information
Primary
Sylvie Lambert, PhD
sylvie.lambert@mcgill.ca
514-398-3685
Backup
Margit Fuchs, PhD
margit.fuchs@mcgill.ca
514-396-2847
Time Frame
Start Date: 2025-05
Estimated Completion Date: 2028-08-31
Participants
Target number of participants: 376
Treatments
Experimental: TEMPO
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).
Active_comparator: Actively Monitoring dyads' anxiety
Patients will receive usual care throughout the study.
Sponsors
Collaborators: Université de Montréal, CISSS de Laval, Simon Fraser University, McGill University, University of British Columbia, Université de Sherbrooke, University of Calgary, Princess Margaret Hospital, Canada, Sunnybrook Health Sciences Centre, Memorial University of Newfoundland
Leads: St. Mary's Research Center, Canada

This content was sourced from clinicaltrials.gov