Recruiting

TEMPO

Sponsor:

St. Mary's Research Center, Canada

Code:

NCT06363266

Conditions

Cancer of the Prostate

Anxiety

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

TEMPO

Active Monitoring dyads' anxiety

Study Details

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.

Conditions

Cancer of the Prostate

Anxiety

Study ID

NCT06363266

Start date

Aug 1, 2025

Status verified date

Jun, 2026

Completion date

Aug 31, 2028

Anticipated

Primary completion date

Oct 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Patient inclusion criteria: Prostate cancer diagnosis; Treatment for prostate cancer (excluding active surveillance) scheduled to start or received within the past 2 years; Nominate a caregiver willing to participate; Report at least moderate anxiety (ESAS-r Anxiety 3+); Be able to read English or French; Have access to the internet

Caregiver inclusion criteria: Are nominated by patient as primary support person; Are patients' spouse, partner, or other family member; If patient does not report moderate anxiety, caregiver needs to; Be able to read English or French; Have access to the internet

Exclusion criteria for patient and caregiver: Hospitalized

Study Design

Enrollment

376 participants

Anticipated

Allocation

Randomized

Intervention Model

Sequential

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

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.

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.

Primary outcome measure

  • Anxiety [ Time Frame: T0: Baseline; T1: 13 weeks post-baseline; T2: 25 weeks post-baseline ]

Central Contacts and Locations

Central contacts

Sylvie Lambert, PhD

514-398-3685sylvie.lambert@mcgill.ca

Margit Fuchs, PhD

514-396-2847margit.fuchs@mcgill.ca

Locations

St Mary's Hospital Research Centre

Recruiting

Montreal, Canada, Canada

Contacts

Manon de Raad

manon.deraad@ssss.gouv.qc.ca

St. Mary's Research Centre

Recruiting

Montreal, Quebec, Canada, H3T1M5

Contacts

Sylvie Lambert, PhD

514-398-3685sylvie.lambert@mcgill.ca

More Information

Sponsor

St. Mary's Research Center, Canada

Last update posted

Jun 11, 2026

Last verified

Jun, 2026

Keywords

  • Behavior Change
  • Caregivers
  • Coping
  • E-Health
  • Illness Self-Management
  • Physical Activity
  • Psychosocial Oncology
  • Self-Directed Interventions
  • Web-Based Interventions

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by St. Mary's Research Center, Canada on 2026-06-11.