Ignite Creation Date:
2024-05-06 @ 7:56 PM
Last Modification Date:
2024-10-26 @ 3:17 PM
Study NCT ID:
NCT06193369
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-01-05
First Post:
2023-12-21
Brief Title:
Digital Peer Navigation for Adolescents and Young Adults With Cancer
Sponsor:
University Health Network Toronto
Organization:
University Health Network Toronto
Study Overview
Official Title:
Digital Peer Navigation for Adolescents and Young Adults With Cancer A Feasibility Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
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:
Adolescents and young adults AYA diagnosed with cancer experience unique challenges after completing treatment and face distinct barriers to optimal care and support These challenges include higher levels of symptom burden and treatment complications interrupted education careers and relationships and financial hardship AYA lack access to peers relevant information and emotional support and report gaps in care when dealing with these difficult challenges
Digital peer navigation could help to address the needs of AYA and overcome barriers to care and support The PI developed True North Peer Navigation TrueNTH-PN an evidence-based digital peer navigation program for men with prostate cancer and online peer navigator training course The goal of this project is to adapt TrueNTH-PN for AYA and evaluate its feasibility to overcome barriers to care and support and enhance patient activation among AYA during the challenging post-treatment phase
In partnership with AYA cancer survivors the Canadian Cancer Society Young Adult Cancer Canada a digital app design firm and technology provider our cross-Canada team will 1 Adapt and evaluate the usability of the TrueNTH-PN app for AYA 2 Adapt and evaluate the effectiveness of the Peer Navigator Training Course for AYA and 3 Determine the feasibility acceptability and preliminary effectiveness of the new AYA-PN program among post-treatment AYA cancer survivors
This project will produce an innovative solution to an important service gap in the lives of AYA with cancer It has the potential to address the support needs of AYA overcome barriers to care and empower AYA to take proactive role in managing their health In addition it will give rise to AYA peer navigators with specialized skills which could fill gaps in disrupted education and career paths and help to attain future goals
Digital peer navigation could help to address the needs of AYA and overcome barriers to care and support The PI developed True North Peer Navigation TrueNTH-PN an evidence-based digital peer navigation program for men with prostate cancer and online peer navigator training course The goal of this project is to adapt TrueNTH-PN for AYA and evaluate its feasibility to overcome barriers to care and support and enhance patient activation among AYA during the challenging post-treatment phase
In partnership with AYA cancer survivors the Canadian Cancer Society Young Adult Cancer Canada a digital app design firm and technology provider our cross-Canada team will 1 Adapt and evaluate the usability of the TrueNTH-PN app for AYA 2 Adapt and evaluate the effectiveness of the Peer Navigator Training Course for AYA and 3 Determine the feasibility acceptability and preliminary effectiveness of the new AYA-PN program among post-treatment AYA cancer survivors
This project will produce an innovative solution to an important service gap in the lives of AYA with cancer It has the potential to address the support needs of AYA overcome barriers to care and empower AYA to take proactive role in managing their health In addition it will give rise to AYA peer navigators with specialized skills which could fill gaps in disrupted education and career paths and help to attain future goals
Detailed Description:
Background Adolescent and young adult AYA cancer survivors experience unique challenges and face distinct barriers to optimal post-treatment survivorship care and support which can impede their recovery These include high levels of symptom burden and treatment-related complications interrupted education careers and relationships and financial toxicity AYA lack access to peers relevant information and emotional support and report gaps in care when dealing with these difficult challenges Previous research has shown that patient navigation improves the timeliness of care and support and reduces healthcare costs Engaging trained volunteer cancer survivors as peer navigators minimizes resource requirements is preferred by AYA over professional support and benefits the navigator by improving their psychosocial health The PI developed True North Peer Navigation TrueNTH-PN an evidence-based digital peer navigation program for men with prostate cancer and online competency-based peer navigator training course Patients are matched through a digital app with a trained peer navigator who assesses needs and barriers to care provides practical informational and emotional support and empowers a proactive approach to health TrueNTH-PN has been shown to be highly acceptable to prostate cancer patients and peer navigators and associated with improvements in patient activation social support and quality of life
Aim This study aims to adapt and evaluate a digital peer navigation program for AYA cancer survivors to overcome barriers to care and support and enhance patient activation during the post-treatment survivorship phase
Specific Objectives This 3-phase project will 1 Adapt and evaluate the usability of the TrueNTH-PN app for AYA 2 Adapt and evaluate the effectiveness of TrueNTH-PN peer navigator training course for AYA and 3 Determine the feasibility acceptability and preliminary effectiveness of the new AYA peer navigation program AYA-PN
Methods We will adopt an iKT approach with patients Canadian Cancer Society and Young Adult Cancer Canada as partners along with a digital app design firm and technology provider For objective 1 informed by Barrera and Castros cultural adaptation framework and user-centred design we will engage AYA in a critical assessment of the existing TrueNTH-PN app to identify areas in need of adaptation for AYA co-design content and processes adaptations and conduct user-testing For objective 2 we will tailor and validate the relevance of the course content for AYA recruit screen and train 20 AYA cancer survivors to be peer navigators and informed by the Kirkpatrick training program framework evaluate the training course using pre-post questionnaires to assess knowledge and self-efficacy for navigator competencies For objective 3 we will conduct a pilot RCT of the new AYA-PN program compared to wait list control with an embedded process evaluation to determine 1 feasibility 2 acceptability and 3 preliminary effectiveness on patent activation supportive care needs quality of life anxietydepression social support and post-traumatic growth Eighty AYA n40 per arm will be recruited after completing treatment Outcomes will be assessed at baseline T0 and 3-months T1 In addition we will evaluate patient-navigator interactions app usage and cost-effectiveness and conduct semi-structured interviews with patients and navigators informed by the Consolidated Framework for Implementation Research to capture experiences explore mechanisms of action and identify implementation barriers and facilitators
Significance This study will produce an innovative solution to an important service gap in the lives of AYA with cancer It is highly aligned with the CCS priority in AYA survivorship care the Pan-Canadian Cancer Survivorship Research Agenda and the SPOR mandate to make research more responsive to the needs of Canadians
Aim This study aims to adapt and evaluate a digital peer navigation program for AYA cancer survivors to overcome barriers to care and support and enhance patient activation during the post-treatment survivorship phase
Specific Objectives This 3-phase project will 1 Adapt and evaluate the usability of the TrueNTH-PN app for AYA 2 Adapt and evaluate the effectiveness of TrueNTH-PN peer navigator training course for AYA and 3 Determine the feasibility acceptability and preliminary effectiveness of the new AYA peer navigation program AYA-PN
Methods We will adopt an iKT approach with patients Canadian Cancer Society and Young Adult Cancer Canada as partners along with a digital app design firm and technology provider For objective 1 informed by Barrera and Castros cultural adaptation framework and user-centred design we will engage AYA in a critical assessment of the existing TrueNTH-PN app to identify areas in need of adaptation for AYA co-design content and processes adaptations and conduct user-testing For objective 2 we will tailor and validate the relevance of the course content for AYA recruit screen and train 20 AYA cancer survivors to be peer navigators and informed by the Kirkpatrick training program framework evaluate the training course using pre-post questionnaires to assess knowledge and self-efficacy for navigator competencies For objective 3 we will conduct a pilot RCT of the new AYA-PN program compared to wait list control with an embedded process evaluation to determine 1 feasibility 2 acceptability and 3 preliminary effectiveness on patent activation supportive care needs quality of life anxietydepression social support and post-traumatic growth Eighty AYA n40 per arm will be recruited after completing treatment Outcomes will be assessed at baseline T0 and 3-months T1 In addition we will evaluate patient-navigator interactions app usage and cost-effectiveness and conduct semi-structured interviews with patients and navigators informed by the Consolidated Framework for Implementation Research to capture experiences explore mechanisms of action and identify implementation barriers and facilitators
Significance This study will produce an innovative solution to an important service gap in the lives of AYA with cancer It is highly aligned with the CCS priority in AYA survivorship care the Pan-Canadian Cancer Survivorship Research Agenda and the SPOR mandate to make research more responsive to the needs of Canadians
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