Responding to Late Effects in Survivors of Childhood Cancer

Not Applicable

Active, not recruiting

• Conditions: Survivorship; Model of Care; Support

• Registration Number: NCT06586502
• Lead Sponsor: Remziye Semerci

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.

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.

Study Timeline

• Study Start: 2024-06-01
• Study First Submitted: 2024-08-19
• Status Verified: 2024-09
• Study First Submitted QC: 2024-09-03
• Last Update Submitted: 2024-09-03
• Study First Posted: 2024-09-06
• Last Update Posted: 2024-09-06
• Primary Completion: 2026-09
• Study Completion: 2026-12

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 150

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Primary Outcome Measures

Name	Time	Method
Caregiver Quality of Life Cancer	Baseline, Sixth and twelfth month	The scale is a validated and reliable measure, comprising 35 items on a 5-point Likert scale, which we have widely used in other studies with this population (Weitzner et al., 1999). We will compare outcomes of a historical control group (N=100), matched for child age and diagnosis, as closely as possible to identify any significant differences between groups that may be attributed to the RECOVER Model of care.
Distress Thermometer for Parents	Baseline, Sixth and twelfth month	The DT-P is a valid and reliable short screening tool for identifying parental distress. It was developed to determine parents' distress who had chronically ill children (0-18 years). The DT-P consists of a thermometer score from 0 (no distress) to 10 (extreme distress) and a problem list (practical, social, emotional, physical, cognitive, and parenting domains) (Haverman et al., 2013).
Pediatric Integrated Care Survey	Baseline, Sixth and twelfth month	Pediatric Integrated Care Survey

Trial Locations

Locations (1)

Queensland Children's Hospital; 🇦🇺 Brisbane, Center, Australia