A SMART Design to Optimize the Delivery of TEMPO for Men With Prostate Cancer and Their Caregivers
1 other identifier
interventional
376
1 country
2
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started May 2025
Longer than P75 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 9, 2024
CompletedFirst Posted
Study publicly available on registry
April 12, 2024
CompletedStudy Start
First participant enrolled
May 1, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 31, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
August 31, 2028
May 6, 2025
May 1, 2025
1.5 years
April 9, 2024
May 1, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Anxiety
The primary outcome is anxiety to compare TEMPO vs. usual care at 13 weeks and within the TEMPO group, the impact of re-randomizing those who do not benefit from TEMPO to 1a) TEMPO + lay guidance vs. 1b) continue with TEMPO at 25 weeks. The primary measure will be the 7-item Hospital Anxiety and Depression Scale (HADS) - Anxiety subscale, which was used in the research teams' pilot and has strong and validity to assess anxiety symptoms among dyads, including responsiveness. A psychometric review of anxiety and depression questionnaires used with patients with cancer identified the HADS as one of the questionnaires with the strongest psychometric properties. The scale range is 0-21. Subscale scores of 0-7 are categorized as normal, subscale scores of 8 to 10 are categorized as borderline and scores of 11 to 21 as clinical anxiety.
T0: Baseline; T1: 13 weeks post-baseline; T2: 25 weeks post-baseline
Secondary Outcomes (7)
Perceived Stress Scale (PSS)
T0: Baseline; T1: 13 weeks post-baseline; T2: 25 weeks post-baseline
Patient-Reported Outcome Measurement Information System (PROMIS) Self-Efficacy Scale
T0: Baseline; T1: 13 weeks post-baseline; T2: 25 weeks post-baseline
Health Education Impact Questionnaire (heiQ)
T0: Baseline; T1: 13 weeks post-baseline; T2: 25 weeks post-baseline
Godin Leisure-Time Exercise Questionnaire (GLTEQ)
T0: Baseline; T1: 13 weeks post-baseline; T2: 25 weeks post-baseline
Dyadic Coping Inventory (DCI)
T0: Baseline; T1: 13 weeks post-baseline; T2: 25 weeks post-baseline
- +2 more secondary outcomes
Study Arms (2)
TEMPO
EXPERIMENTALUsing 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).
Actively Monitoring dyads' anxiety
ACTIVE COMPARATORPatients will receive usual care throughout the study.
Interventions
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.
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.
Eligibility Criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- St. Mary's Research Center, Canadalead
- Princess Margaret Hospital, Canadacollaborator
- University of Calgarycollaborator
- Sunnybrook Health Sciences Centrecollaborator
- University of British Columbiacollaborator
- McGill Universitycollaborator
- Simon Fraser Universitycollaborator
- Université de Sherbrookecollaborator
- Memorial University of Newfoundlandcollaborator
- Université de Montréalcollaborator
- CISSS de Lavalcollaborator
Study Sites (2)
St Mary's Hospital Research Centre
Montreal, Canada, Canada
St. Mary's Research Centre
Montreal, Quebec, H3T1M5, Canada
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Sylvie Lambert, PhD
McGill University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
April 9, 2024
First Posted
April 12, 2024
Study Start
May 1, 2025
Primary Completion (Estimated)
October 31, 2026
Study Completion (Estimated)
August 31, 2028
Last Updated
May 6, 2025
Record last verified: 2025-05