Ignite Creation Date:
2024-10-26 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06586502
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
None
First Post:
2024-08-19
Brief Title:
Responding to Late Effects in Survivors of Childhood Cancer
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Responding to Late Effects in Survivors of Childhood Cancer RECOVER
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Survivors of childhood cancer need ongoing support to navigate their needs after cancer treatment Using technology may offer us new ways to collect and share information about cancer survivorship follow-up with young survivors their carers and primary care providers
Through the support of the Kids Cancer Project in Phase 1 of this study will co-design an electronic survivorship portal that links young survivors with their cancer treatment information and health care teams In later Phases we will implement and evaluate the survivorship portal
Through the support of the Kids Cancer Project in Phase 1 of this study will co-design an electronic survivorship portal that links young survivors with their cancer treatment information and health care teams In later Phases we will implement and evaluate the survivorship portal
Detailed Description:
The RECOVER study aims to develop and implement a comprehensive Model of Care for childhood cancer survivors integrating technology and a human-centered co-design approach to provide continuous holistic care Our primary objectives are to assess the feasibility and acceptability of the RECOVER Model of Care in routine pediatric oncology practice Secondary objectives include evaluating preliminary efficacy results and identifying factors that influence the successful adoption and integration of the model
Data Sources This project will be conducted in three settings in Australia The study will use a mixed methods approach starting with a feasibility study Phase 1 following implementation science methods to assess the integration of the new Model of Care Phase 2 and culminating in a Type 2 Hybrid ImplementationEffectiveness non-randomized controlled trial Phase 3 to compare historical and prospective data The quantitative component of RECOVER non-randomized controlled study will involve the use of digital technologies to 1 enable multimodal real-world data collection 2 provide patients and caregivers with an interactive supportive digital interface and 3 equip healthcare professionals with a comprehensive patient-monitoring system The qualitative component will determine end-user feasibility and acceptability through focus group workshops surveys and interviews
Data Sources This project will be conducted in three settings in Australia The study will use a mixed methods approach starting with a feasibility study Phase 1 following implementation science methods to assess the integration of the new Model of Care Phase 2 and culminating in a Type 2 Hybrid ImplementationEffectiveness non-randomized controlled trial Phase 3 to compare historical and prospective data The quantitative component of RECOVER non-randomized controlled study will involve the use of digital technologies to 1 enable multimodal real-world data collection 2 provide patients and caregivers with an interactive supportive digital interface and 3 equip healthcare professionals with a comprehensive patient-monitoring system The qualitative component will determine end-user feasibility and acceptability through focus group workshops surveys and interviews
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None