Actively Recruiting
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
Led by St. Mary's Research Center, Canada · Updated on 2025-05-06
376
Participants Needed
2
Research Sites
95 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
Researchers are evaluating the TEMPO program, a self-directed, web-based psychosocial and physical activity management tool designed for men with prostate cancer and their family caregivers. The study aims to reduce anxiety and improve coping skills by addressing the physical and emotional challenges caused by prostate cancer and its treatment. This research uses a sequential multiple assignment randomized trial (SMART) design to find the most effective and cost-efficient way to deliver TEMPO, including options for additional guidance when needed. Participants will be randomly assigned to either use the TEMPO program or actively monitor their anxiety for 12 weeks. After this period, those still experiencing anxiety may receive extended TEMPO support or guidance through scheduled phone or online calls from trained non-health care professionals. The study includes two intervention stages, each lasting 12 weeks, with usual care continuing alongside the program. Active monitoring participants who need more support will gain access to TEMPO in the second stage. Throughout the study, participants complete surveys at baseline, 13 weeks, and 25 weeks to assess anxiety and other health outcomes like stress, self-efficacy, exercise habits, and coping. The research team tracks anxiety levels and evaluates the cost-effectiveness of TEMPO compared to active monitoring. The total participation time spans about 25 weeks, with data collected to understand the program's impact on both patients and caregivers.
CONDITIONS
Brief 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...
- Diagnosed with prostate cancer
- Receiving or scheduled to receive treatment for prostate cancer (excluding active surveillance) within the past 2 years
- Have a caregiver willing to participate
- Report at least moderate anxiety (ESAS-r Anxiety score of 3 or higher)
- Able to read English or French
- Have access to the internet
You will not qualify if you...
- Currently hospitalized (for both patient and caregiver)
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 screening visit (in-person or phone) to complete eligibility assessment and consent
Duration - 12 weeks
Participants are randomized to either use TEMPO, a web-based psychosocial and physical activity self-management program, or to active monitoring with usual care for 12 weeks.
Online baseline questionnaire and follow-up assessments at 12 weeks
Duration - 13 weeks
After 12 weeks, participants using TEMPO who continue to experience anxiety are re-randomized to receive either continued self-directed TEMPO or TEMPO plus guidance through eight 20-minute phone or online calls. Participants initially in active monitoring who do not respond are stepped up to TEMPO. This stage lasts 13 weeks.
Eight guidance calls for those receiving guidance; ongoing access to TEMPO for others; follow-up assessments at 25 weeks
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
M
Margit Fuchs, PhD
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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