Ignite Creation Date:
2024-05-06 @ 8:23 PM
Last Modification Date:
2025-12-16 @ 5:29 PM
Study NCT ID:
NCT06363266
Status:
None
Last Update Posted:
2025-05-06 00:00:00
First Post:
2024-04-09 00:00:00
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. Mary's 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:
None
Status Verified Date:
2025-05
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:
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.
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.
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