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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06586502




Registration number
NCT06586502
Ethics application status
Date submitted
19/08/2024
Date registered
19/09/2024
Date last updated
19/09/2024

Titles & IDs
Public title
Responding to Late Effects in Survivors of Childhood Cancer
Scientific title
Responding to Late Effects in Survivors of Childhood Cancer (RECOVER)
Secondary ID [1] 0 0
QUT
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Survivorship 0 0
Model of Care 0 0
Support 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - Model of Care

No intervention: Control Group - 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.

Experimental: Intervention Group - 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 interventions: Model of Care
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 code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Caregiver Quality of Life Cancer
Assessment method [1] 0 0
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.
Timepoint [1] 0 0
Baseline, Sixth and twelfth month
Primary outcome [2] 0 0
Pediatric Integrated Care Survey
Assessment method [2] 0 0
Pediatric Integrated Care Survey
Timepoint [2] 0 0
Baseline, Sixth and twelfth month
Primary outcome [3] 0 0
Distress Thermometer for Parents
Assessment method [3] 0 0
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).
Timepoint [3] 0 0
Baseline, Sixth and twelfth month

Eligibility
Key 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
Minimum age
No limit
Maximum age
35 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key 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
Purpose of the study
Other
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/06/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/12/2026
Actual
Sample size
Target
150
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Cente
Recruitment hospital [1] 0 0
Queensland Children's Hospital - Brisbane
Recruitment postcode(s) [1] 0 0
4101 - Brisbane

Funding & Sponsors
Primary sponsor type
Other
Name
Remziye Semerci
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Public notes

Contacts
Principal investigator
Name 0 0
Natalie Bradford, Bradford
Address 0 0
Cancer and Palliative Care Outcomes Centre
Country 0 0
Phone 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT06586502