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

Anxiety Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06363266
• Other study ID #: 190211_1
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 1, 2024
• Est. completion date: August 31, 2028

Study information

• Verified date: April 2024
• Source: St. Mary's Research Center, Canada
• Contact: Sylvie Lambert, PhD
• Phone: 514-398-3685
• Email: sylvie.lambert[@]mcgill.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 study is a Sequential Multiple Assignment Randomized Trial (SMART) with two sequential intervention stages, cost-effectiveness analysis, and exit qualitative interviews. 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). Dyads will initially be randomized to 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).

Patient inclusion criteria are:

• Received treatment for prostate cancer (excluding active surveillance) within the past two years

• Identified a primary caregiver willing to participate in the study

• One member of the dyad has anxiety symptoms

• Has access to the internet,

• Understands English or French. Eligible caregivers will be those identified by the patient as his primary source of support. Caregivers also need to be able to read English or French.

Dyads exclusion criteria are:

• Either member of the dyad is hospitalized at recruitment

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 Centre Hospitalier de l'Université de Montréal. 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 376
• Est. completion date: August 31, 2028
• Est. primary completion date: August 31, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• treatment for prostate cancer (excluding active surveillance) received within the past 2 years

• participate with a self-identified caregiver

• one member of the dyad has anxiety symptoms

• Patients and caregivers need to be able to read English or French

• internet access

Exclusion Criteria:

• either member of the dyad is hospitalized at recruitment

Related Conditions & MeSH terms

• Anxiety
• Cancer of the Prostate
• Prostatic Neoplasms

Intervention

Behavioral:
• TEMPO
Stage 1 interventions (week 1-12): After 12 weeks, response will be determined. At recruitment, at least one member of the dyad must report anxiety symptoms defined as a Hospital Anxiety and Depression Scale (HADS)-Anxiety subscale score > 6. After Stage 1, for the dyad to be "TEMPO Responder", both members' anxiety scores on the HADS-Anxiety must be < 6 or decreased by at least 2 points. If both members of the dyad had anxiety symptoms at recruitment, then both must meet a response criterion. As soon as one dyad member does not meet the response criterion, the dyad is "TEMPO non-responder". Stage 2 interventions (week 14-25): TEMPO responders continue with TEMPO. Non-responders will be re-randomized to: a) more time with TEMPO or b) add non-health care professional guidance (8 x 20-minute telephone calls). Guides' training will include TEMPO review, their role and the manual. Semi-structured exit interview will gather guides' experiences.

Other:
• 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 14-25): 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.

Locations

Country	Name	City	State
Canada	St. Mary's Research Centre	Montreal	Quebec
Canada	St Mary's Hospital Research Centre	Montréal

Sponsors (11)

Lead Sponsor	Collaborator
St. Mary's Research Center, Canada	Centre intégré de santé et de services sociaux (CISSS) de Laval, McGill University, Memorial University of Newfoundland, Princess Margaret Hospital, Canada, Simon Fraser University, Sunnybrook Health Sciences Centre, Université de Montréal, Université de Sherbrooke, University of British Columbia, University of Calgary

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HADS-Anxiety	Patients and caregivers will each complete their own self-administered questionnaire at T0-T2 via Qualtrics, a secure electronic data capture system. HADS-Anxiety has strong reliability and validity to assess anxiety symptoms among dyads, including responsiveness. Our previous studies supported its ability to discriminate between anxiety and depression. To avoid testing effect, the HADS-Anxiety score obtained at eligibility screening will be used as baseline, if completed within 2 weeks of baseline, consistent with the HADS' test-retest reliability. In our SMART Coping-Together pilot, most dyads completed eligibility and baseline questionnaires within 1 week.	Baseline, 12 weeks post-baseline and 24 weeks post-baseline
Secondary	TEMPO's key mechanisms of action	We will document TEMPO's key mechanisms of action: Primary appraisal = Perceived Stress Scale; secondary appraisal = PROMIS self-efficacy scale and the Multidimensional Self-Efficacy for Exercise Scale; self-management = Health Education Impact Questionnaire and Godin Leisure-Time Exercise Questionnaire (GLTEQ); coping = Dyadic Coping Inventory; depression = HADS-depression, and quality of life = SF-12. All measures were used in our pilot and have demonstrated psychometric properties. For physical activity, the modified GLTEQ is moderately correlated with pedometer and accelerometer derived activity data. Dyads will log weekly their step count in a Participant Steps Diary using the pedometer provided or their own devices.	Baseline, 12 weeks post-baseline and 24 weeks post-baseline