Responding to Late Effects in Survivors of Childhood Cancer

Remziye Semerci

Status: Active, not recruiting

Conditions: Survivorship; Model of Care; Support

Treatments: Other: Model of Care

Study type: Interventional

Funder types: Other

Identifiers

NCT06586502

QUT

Details and patient eligibility

About

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.

Full 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.

Enrollment: 150 estimated patients

Sex: All

Ages: Under 35 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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150 participants in 2 patient groups

Control Group

No Intervention group

Description:

We will compare outcomes of a historical control group, 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.

Intervention Group

Experimental group

Description:

The intervention group in the RECOVER study consists of cancer survivors aged 15-39 years who have completed treatment, along with their carers or parents, and health professionals. The survivors will undergo a comprehensive health assessment, including both physical and psychological aspects, to inform the development of a personalized care plan. Carers or parents, who must be able to read and understand English or work with an interpreter, will be actively involved in the assessment process and subsequent consultations to help shape the care plan. Health professionals, including doctors, nurses, and allied health providers from Queensland Health public hospitals, will participate in multidisciplinary team meetings, review health assessments, and contribute to the creation and implementation of the care plan. These groups together form the core of the intervention, engaging in both the application and evaluation of the RECOVER Model of Car

Treatment:

Other: Model of Care