Responding to Late Effects in Survivors of Childhood Cancer

NCT06586502 | Active Not Recruiting DMC

• 1 other identifier: QUT
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Survivorship; Model of Care; Support

Outcome Measures

Primary Outcomes (3)

• Caregiver Quality of Life Cancer

  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.

  Baseline, Sixth and twelfth month

• Pediatric Integrated Care Survey

  Pediatric Integrated Care Survey

  Baseline, Sixth and twelfth month

• Distress Thermometer for Parents

  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).

  Baseline, Sixth and twelfth month

Study Arms (2)

Control Group

NO INTERVENTION

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

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

Other: Model of Care

Interventions

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.

Intervention Group

Eligibility Criteria

• Age: Up to 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• Patients deemed unsuitable by their clinical treatment team due to potential distress or lack of cognitive or communicative capacity.

Sponsors & Collaborators

• Remziye Semerci: lead

Study Sites (1)

Queensland Children's Hospital

Brisbane, Center, 4101, Australia

Location

Study Officials

• Natalie Bradford, Bradford

  Cancer and Palliative Care Outcomes Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: August 19, 2024
• First Posted: September 19, 2024
• Study Start: June 1, 2024
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)