Responding to Late Effects in Survivors of Childhood Cancer

Trial Title: Responding to Late Effects in Survivors of Childhood Cancer

NCT ID: NCT06586502

Condition: Survivorship
Model of Care
Support

Study type: Interventional

Study phase: N/A

Overall status: Active, not recruiting

Study design:

Allocation: Non-Randomized

Intervention model: Sequential Assignment

Primary purpose: Supportive Care

Masking: None (Open Label)

Intervention:

Intervention type: Other
Intervention name: Model of Care
Description: The intervention described in the RECOVER study involves developing, implementing, and evaluating a comprehensive Model of Care for childhood cancer survivors. This model, known as the RECOVER Model of Care, integrates digital health solutions and is co-designed with input from childhood cancer survivors, caregivers, and clinical experts. The intervention aims to address the long-term and late effects of cancer treatment by providing continuous, risk-based, interdisciplinary care. It includes steps such as identifying patients nearing the end of treatment, conducting health assessments, creating personalized care plans, and coordinating follow-up care through digital platforms. The study will assess the feasibility, acceptability, and effectiveness of this model in improving the quality of life and care experience for survivors and their families.
Arm group label: Intervention Group

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.

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 Implementation/Effectiveness 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.

Criteria for eligibility:
Criteria:
Inclusion Criteria: - Patients aged 15-39 years who have completed cancer treatment. - Ability to read and understand English. - Willingness to comply with study procedures and provide informed consent. - Clinicians (doctors, nurses, allied health professionals) providing care through *Queensland Health public hospitals Exclusion Criteria: - Patients deemed unsuitable by their clinical treatment team due to potential distress or lack of cognitive or communicative capacity. - None specified, as long as they meet the inclusion criteria.

Gender: All

Minimum age: N/A

Maximum age: 35 Years

Healthy volunteers: Accepts Healthy Volunteers

Locations:

Facility:
Name: Queensland Children's Hospital

Address:
City: Brisbane
Zip: 4101
Country: Australia

Start date: June 1, 2024

Completion date: December 2026

Lead sponsor:
Agency: Remziye Semerci
Agency class: Other

Source: Trakya University

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06586502