Ignite Creation Date:
2024-05-06 @ 8:23 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06363266
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-12
First Post:
2024-04-09
Brief Title:
A SMART Design to Optimize the Delivery of TEMPO for Men With Prostate Cancer and Their Caregivers
Sponsor:
St Marys Research Center Canada
Organization:
St Marys Research Center Canada
Study Overview
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
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Men with prostate cancer and their family caregivers face many physical and emotional challenges from the cancer itself and its treatments 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 mens 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 eg treatment decision-making men face daily These challenges can be successfully mitigated through self-management defined as ones actions and decisions to confidently manage medical aspects of cancer cope with emotions adjust everyday life and enhance recovery eg 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 TEMPOs use since the last call Guides conclude calls by reviewing dyads 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 lUniversité de Montréal Several Cancer Agencies are exploring TEMPOs integration in their resource infrastructure However a definitive trial on efficacy cost-effectiveness and adaptation to meet dyads needs for guidance is needed The research team will also contribute to the emerging literature on SMARTs for behavioral interventions
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 TEMPOs use since the last call Guides conclude calls by reviewing dyads 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 lUniversité de Montréal Several Cancer Agencies are exploring TEMPOs integration in their resource infrastructure However a definitive trial on efficacy cost-effectiveness and adaptation to meet dyads needs for guidance is needed The research team will also contribute to the emerging literature on SMARTs for behavioral interventions
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None