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Active, Not Recruiting

NCT Number: NCT06586502

Responding to Late Effects in Survivors of Childhood Cancer

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Survivorship Model of Care Support

Age range

Up to 35 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Queensland Children's Hospital

Brisbane, Center, 4101, Australia

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Model of Care

Other

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.

Primary outcomes

  1. Caregiver Quality of Life Cancer

    Time frame: 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.

  2. Pediatric Integrated Care Survey

    Time frame: Baseline, Sixth and twelfth month

    Pediatric Integrated Care Survey

  3. Distress Thermometer for Parents

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

Remziye Semerci

Other

Registry information

Official study title

Responding to Late Effects in Survivors of Childhood Cancer (RECOVER)

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Sep 19, 2024
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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