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A SMART Design to Optimize the Delivery of TEMPO for Men With Prostate Cancer and Their Caregivers
Sponsor: St. Mary's Research Center, Canada
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.
Official title: 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
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
376
Start Date
2025-05
Completion Date
2028-08-31
Last Updated
2025-05-06
Healthy Volunteers
No
Conditions
Interventions
TEMPO
Stage 1 interventions (weeks 1-12): TEMPO. After 12 weeks, the benefit of the initial assignment will be assessed. Benefit is defined as a score \< 3 on the ESAS-r anxiety item (range 0-10) or a decrease \>= 2 points from eligibility screening. If both dyad members had anxiety symptoms at recruitment, both must meet the benefit criterion. If one member no longer meets the criterion, the dyad is considered "did not benefit." Stage 2 interventions (weeks 13-25): TEMPO or lay guidance. 1. TEMPO responders will continue with TEMPO. Dyads who did not benefit will be re-randomized to: 1. Stepping up to lay guidance (8 x 20-minute calls via phone or Teams). Guides will receive TEMPO training and conduct semi-structured exit interviews. 2. More time with TEMPO for dyads who benefited from it. 2. Non-responders to usual care in Stage 1 will be stepped up to TEMPO.
Active Monitoring dyads' anxiety
Stage 1 interventions (week 1-12): Patients will receive usual care throughout the study. Dyads in this group will not receive any information resources from the research team but will have access to all of those available at their participating center (sites will be asked to provide a description of usual care practices). Stage 2 interventions (week 13-25): Dyads not responding to active monitoring will be stepped up to TEMPO; responders to active monitoring will only be invited to complete the follow-up measures.
Locations (2)
St Mary's Hospital Research Centre
Montreal, Canada, Canada
St. Mary's Research Centre
Montreal, Quebec, Canada