Clinical trial NCT06586502: Responding to Late Effects in Survivors of Childhood Cancer
Official title: Responding to Late Effects in Survivors of Childhood Cancer (RECOVER)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Survivorship
Model of Care
Support
Lead sponsor: Trakya University
Sponsor class: OTHER
First posted: 2024-09-19
Enrollment: 150
Sex: ALL
Maximum age (years): 35
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: SUPPORTIVE_CARE

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.

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.

Primary outcomes:
measure: Caregiver Quality of Life Cancer
timeFrame: Baseline, Sixth and twelfth month
measure: Pediatric Integrated Care Survey
timeFrame: Baseline, Sixth and twelfth month
measure: Distress Thermometer for Parents
timeFrame: Baseline, Sixth and twelfth month
Secondary outcomes:
Other outcomes:
Locations:
city: Brisbane
country: Australia
facility: Queensland Children's Hospital
state: Center
Study officials:
affiliation: Cancer and Palliative Care Outcomes Centre
name: Natalie Bradford, Bradford
role: PRINCIPAL_INVESTIGATOR
References: