Actively Recruiting
A SMART Design to Optimize the Delivery of TEMPO for Men With Prostate Cancer and Their Caregivers
Led by St. Mary's Research Center, Canada · Updated on 2025-05-06
376
Participants Needed
2
Research Sites
174 weeks
Total Duration
On this page
Sponsors
S
St. Mary's Research Center, Canada
Lead Sponsor
P
Princess Margaret Hospital, Canada
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
A SMART Design to Optimize the Delivery of TEMPO for Men With Prostate Cancer and Their Caregivers
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Men diagnosed with prostate cancer
- Scheduled to start or received prostate cancer treatment (excluding active surveillance) within the past 2 years
- Able to read English or French
- Have access to the internet
- Report at least moderate anxiety (ESAS-r Anxiety score 3 or higher)
- Have a nominated caregiver willing to participate
- Caregivers must be the patient's spouse, partner, or other family member
- Caregivers able to read English or French
- Caregivers have access to the internet
- If the patient does not report moderate anxiety, the caregiver must have moderate anxiety
You will not qualify if you...
- Currently hospitalized (applies to both patients and caregivers)
AI-Screening
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Trial Site Locations
Total: 2 locations
1
St Mary's Hospital Research Centre
Montreal, Canada, Canada
Actively Recruiting
2
St. Mary's Research Centre
Montreal, Quebec, Canada, H3T1M5
Actively Recruiting
Research Team
S
Sylvie Lambert, PhD
CONTACT
M
Margit Fuchs, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
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