A SMART Design to Optimize the Delivery of TEMPO for Men With Prostate Cancer and Their Caregivers

NCT ID: NCT06363266

Last Updated: 2025-05-06

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 376 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-05-31
• Study Completion Date: 2028-08-31

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.

Detailed Description

BACKGROUND : Up to 60% of men with prostate cancer report some level of anxiety, with clinical levels exceeding population norm. Anxiety results from reactions to the diagnosis, treatment side effects, and the multitude of other anxiety-provoking physical and psychosocial challenges (e.g., treatment decision-making) men face daily. These challenges can be successfully mitigated through self-management, defined as one's actions and decisions to confidently manage medical aspects of cancer, cope with emotions, adjust everyday life, and enhance recovery (e.g., via lifestyle changes). Cancer care lags in the implementation of self-management support, mostly because it requires clinicians' engagement, which conflicts with their limited availability, even if self-management is cost-effective. Men then often lack knowledge for effective self-management; cancer challenges often persist, along with the anxiety they provoke. Cancer challenges are not self-managed in a vacuum; family caregivers are often relied on. The impact of caregiving is substantial, but often dismissed, resulting in high caregiver anxiety. TEMPO, a self-directed, dyadic Tailored, wEb-based psychosocial and physical activity self-Management PrOgram, was developed because staff shortages necessitate innovative models to deliver sustainable self-management support, without compromising efficacy. TEMPO is a tool to help address the quadruple aim of healthcare: enhance dyads' and clinicians' experiences and improve health outcomes at low cost. However, in a pilot study, some dyads needed more guidance to use TEMPO. Barriers to use were mostly motivational, which the investigators previously found can be effectively addressed by guidance from non-health care professionals to spare clinical resources.

OBJECTIVES : The goal of this study is to determine the most efficacious and cost-effective way of adapting TEMPO to dyads' needs for guidance. The primary hypotheses are that a) TEMPO dyads will experience lower anxiety than active monitoring dyads, but dyads needing guidance will report lower anxiety post guided TEMPO than if they had continued with TEMPO self-directed; and b) TEMPO will be cost-effective compared to active monitoring; adding guidance will demonstrate cost-effectiveness among those needing it. For the secondary hypotheses, same effects are expected of TEMPO and guidance on the secondary outcomes and between-group differences in anxiety will be higher among caregivers who are mostly females and women.

METHODOLOGY : This multicenter study is a stratified Sequential Multiple Assignment Randomized Trial (SMART) across Canada with two sequential intervention stages, cost-effectiveness analysis, and exit qualitative interviews. Study activities will be coordinated out of St Mary's Research Centre in Montreal. 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). At each centre, clinical collaborators (physicians, nurses, trial nurse, secretaries etc) may provide brief information on the study to the target population before, during or after an appointment. At this time, interested individuals may be given a study pamphlet or be directed to a displayed poster and the clinical collaborator will obtain permission for a RA to approach them. Further recruitment strategies may include: direct approaches of patients by the RA in the waiting room; invitation letters sent to all patients in the target population matching certain key inclusion criteria without specifically singling out any individual patients including RA contact information; advertisement of the study on social media including contact information of the research team; contact by email of individuals within the target population who have been identified by the investigators during previous research activities.

Depending on the way interested individuals were identified, the RA will use the content of the consent form and the study pamphlet to explain the study in detail. All screening will be done as a structured interview in-person or over the phone where the RA will complete the eligibility form with patients and their caregivers. The form might be sent to potential participants directly to complete online. If the caregiver is not present, the RA will provide study information to the patient and obtain his/her verbal consent to follow-up by phone within the next week to determine the caregiver's interest in the study. In addition, each site will display study posters giving potential participants the ability to self-refer.

Eligible patients and caregivers will be issued a consent form in their preferred format, depending on the recruitment context. Once the consent form is received, the link to the online baseline (T0) questionnaire will be emailed. Patient-caregiver dyads returning their consent forms and baseline questionnaires (T0) will be initially randomized by the study coordinator to either a) TEMPO self-directed or b) active monitoring of anxiety. After 12 weeks, TEMPO dyads still reporting anxiety will be re-randomized to more time with TEMPO or TEMPO plus guidance, and active monitoring dyads will be offered TEMPO. All participating dyads will continue to access usual care (a co-intervention measure is included). Group allocation will not be blinded. Dyads will be blinded to hypotheses to reduce bias. Research assistants (RAs) will not interact with randomized participants until the exit interview. Guides are not therapists; they focus on adherence, using TEMPO to answer dyads' questions. Phone calls start with the guide and dyad setting an agenda. Guides then ask about TEMPO's use since the last call. Guides conclude calls by reviewing dyad's goals until the next call. Stages 1 and 2 are 12 weeks each. Outcomes are assessed prior to randomization (baseline, T0) and at completion of Stage 1 (11 weeks post-randomization, T1) and Stage 2 (22 weeks post-randomization, T2).

SIGNIFICANCE :This proposal builds on the investigators' innovative work on efficient, evidence-based dyadic self-management interventions that spare clinical resources but remains efficacious. Clinician partners emphasize the value of TEMPO in their letters of support. Twice as many centres are participating in this trial, compared to the pilot. The research team will make cost-effectiveness recommendations with clinical implementation in mind. Importantly, TEMPO has significant generalizability, as the tools and approaches can readily be adapted to other cancer populations (see letter from Stuart Edmond, Canadian Cancer Society). TEMPO is currently being adapted for use among patients with a head and neck cancer and their caregivers for implementation at the Hospital Center of the University of Montreal. Several Cancer Agencies are exploring TEMPO's integration in their resource infrastructure. However, a definitive trial on efficacy, cost-effectiveness, and adaptation to meet dyad's needs for guidance is needed. The research team will also contribute to the emerging literature on SMARTs for behavioral interventions.

Conditions

Cancer of the Prostate; Anxiety

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: DOUBLE

Study Groups

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).

Group Type: EXPERIMENTAL

TEMPO

Intervention Type: BEHAVIORAL

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.

Actively Monitoring dyads' anxiety

Patients will receive usual care throughout the study.

Group Type: ACTIVE_COMPARATOR

Active Monitoring dyads' anxiety

Intervention Type: OTHER

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.

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.

Intervention Type: BEHAVIORAL

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.

Intervention Type: OTHER

Other Intervention Names

Tailored, wEb-based, Psychosocial and Physical Activity Self- Management PrOgramme

Eligibility Criteria

Inclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Princess Margaret Hospital, Canada

OTHER

Sponsor Role: collaborator

University of Calgary

OTHER

Sponsor Role: collaborator

Sunnybrook Health Sciences Centre

OTHER

Sponsor Role: collaborator

University of British Columbia

OTHER

Sponsor Role: collaborator

McGill University

OTHER

Sponsor Role: collaborator

Simon Fraser University

OTHER

Sponsor Role: collaborator

Université de Sherbrooke

OTHER

Sponsor Role: collaborator

Memorial University of Newfoundland

OTHER

Sponsor Role: collaborator

Université de Montréal

OTHER

Sponsor Role: collaborator

CISSS de Laval

UNKNOWN

Sponsor Role: collaborator

St. Mary's Research Center, Canada

OTHER

Sponsor Role: lead

Responsible Party

Sylvie Lambert

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sylvie Lambert, PhD

Role: PRINCIPAL_INVESTIGATOR

McGill University

Locations

St Mary's Hospital Research Centre

Montreal, Canada, Canada

Site Status: RECRUITING

St. Mary's Research Centre

Montreal, Quebec, Canada

Site Status: RECRUITING

Countries

Canada

Central Contacts

Sylvie Lambert, PhD

Role: CONTACT

sylvie.lambert@mcgill.ca

514-398-3685

Margit Fuchs, PhD

Role: CONTACT

margit.fuchs@mcgill.ca

514-396-2847

Facility Contacts

Manon de Raad

Role: primary

manon.deraad@ssss.gouv.qc.ca

Sylvie Lambert, PhD

Role: primary

sylvie.lambert@mcgill.ca

514-398-3685

Other Identifiers

MP-18-2025-1156

Identifier Type: -

Identifier Source: org_study_id