Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000761662
Ethics application status
Approved
Date submitted
13/04/2023
Date registered
12/07/2023
Date last updated
29/07/2024
Date data sharing statement initially provided
12/07/2023
Type of registration
Retrospectively registered

Titles & IDs
Public title
EMERGE: An Ehealth Model of Care for Paediatric Patients and Families at the End-of-Treatment for Acute Lymphoblastic Leukaemia
Scientific title
EMERGE: An Ehealth Model of Care for Paediatric Patients and Families at the End-of-Treatment for Acute Lymphoblastic Leukaemia
Secondary ID [1] 303770 0
None
Universal Trial Number (UTN)
U1111-1272-5457
Trial acronym
EMERGE
Linked study record
N/A

Health condition
Health condition(s) or problem(s) studied:
Paediatric Acute Lymphoblastic Leukaemia 321613 0
Lymphoblastic Lymphoma 330204 0
Condition category
Condition code
Cancer 319353 319353 0 0
Children's - Leukaemia & Lymphoma
Public Health 326533 326533 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This study will utilise a pragmatic hybrid, non-randomised controlled trial design to evaluate the implementation of a telehealth care program, facilitated by a nurse practitioner (NP) and psycho-social clinician (PSC). An extensive consumer engagement and healthcare service consultation process has been undertaken to inform the development of the program and informational resources to optimise implementation of the program beyond the study period as a clinical standard of care. The program will support young survivors of childhood acute lymphoblastic leukaemia (ALL) and their families through the early survivorship period and into long-term survivorship programs that provide transition to adult services.

There are 2 participant groups in this trial:
a. Intervention participants: Patients and their primary caregiver(s)
b. Stakeholder representatives: Health-care professionals involved in the primary care of these patients

Intervention participants will be patients aged between 2-18 years, and their primary caregiver(s), who are nearing the end of treatment for paediatric ALL at one of the Children's Cancer Centres at the Royal Children's Hospital (RCH) or Monash Children's Hospital (MCH) in Victoria, Australia. To ensure inclusivity, in this trial ALL will be taken to include patients with Lymphoblastic Lymphoma (LLy) who present with similar disease features and undergo identical treatment protocols to ALL patients. Given the high similarities shared by these disease entities, and for ease of reference, we will refer to all patients as having ALL in this protocol.

The Emerge model specifically addresses several areas of need, and incorporates the recommendations of the paediatric oncology psychosocial standards developed in 2015 [1] by including four main components:

1. Screening: The Emerge clinicians will establish a risk profile for each patient/family at the end of active treatment. This will be based on an assessment of psychosocial risk, child/adolescent and parent factors and family adjustment/quality of life using validated questionnaires from multiple informants. Screening measures will be administered at baseline (pre-intervention) to inform the first telehealth session, and repeated pre-telehealth session 2 to inform the second consultation. These screening measures form the basis of the eHealth consultation but are not part of the evaluated outcomes for the study. The primary caregiver for the patient will be asked to fill in the screening measures for each timepoint.

2. Psychoeducation/Resource Provision: Psychoeducation and counselling will be provided directly by the Emerge nurse practitioner/clinical nurse consultant and psychosocial clinician during the scheduled telehealth session. An interdisciplinary survivorship care plan (SCP), treatment summary and tailored information will be provided to families based upon identified areas of need/risk. Referrals will be logged on the Emerge database and suitable local providers (e.g., general practitioner (GP), community psychologist, education services etc.) identified for the family. When appropriate, interventions/goals will be set to guide their engagement in a program.

3. Monitoring and Review: Follow-up surveys, goal/intervention adherence and health service utilisation will be monitored, with the Emerge clinicians reviewing this data on a routine basis in the 2 weeks prior to the telehealth consultations to determine risk level, referral needs and updated recommendations. Follow-up care will then be provided by the clinicians as required via telehealth appointments, face-to-face consultations, or communication with other healthcare providers in the 2-4 weeks post consultation (however this may vary depending on need and service requirements).

4. Specialist Intervention: For patients and families with significant risk factors (e.g. Targeted – moderate risk, and Clinical – high risk), referrals will be actioned to hospital or community-based specialists (e.g., clinical psychology, neuropsychology, occupational therapy, education liaison, medical oncologist etc.). The telehealth platform will allow for group consultations to be organised to assist with specialist support from the tertiary care team. For example, a joint consultation between the family, clinicians, and local GP may form an additional review session to provide an opportunity for clinicians to consult on care requirements, and key recommendations.

Telehealth sessions will occur approximately 3-4 months apart for families in all risk categories (i.e., minimum 2 consultations per year at 3-months (Telehealth session 1) and 6-8 months (Telehealth session 2) following completion of treatment) and will be scaled up if required for those in the Targeted or Clinical groups. Each session will be approximately 1 hour in length. Patients/families will also be able to escalate their concerns to activate an additional telehealth or face-to-face session with their Emerge clinicians or specialist medical consultants (maximum of 4 sessions available over a 12-month period). The overall duration of the intervention for a participant will be 12-months post telehealth consultation 1. Clinicians will log the outcome of each telehealth session including: participants involved, length of session, topics discussed, use of screening tools, hours required in preparation and following the consultation, referrals made, follow-up required and actioned interventions.

Several implementation outcomes will be collected pre-intervention, post telehealth session 1, post telehealth session 2 and at 12-months post-treatment completion for intervention participants including acceptability, satisfaction and service usage. In addition, stakeholder participants will complete questionnaires evaluating the acceptability, feasibility and appropriateness of the intervention at the commencement of the trial at their site and following 12-months of the intervention being open at their cancer centre. Participants may also attend an optional semi-structured qualitative interview 1-2 months post their second telehealth consultation to discuss the barriers and facilitators to implementation of the Emerge program and address the longer-term health care implications for program sustainability. This will be offered to a subset of participants who will be selected via alternating enrolments (every 3rd participant). Stakeholders will also be interviewed to discuss their experience of the Emerge program following the trial being open for 12 months at their site.

[1] Wiener, L., et al., Standards for the Psychosocial Care of Children With Cancer and Their Families: An Introduction to the Special Issue. Pediatr Blood Cancer, 2015. 62 Suppl 5(Suppl 5): p. S419-24.
Intervention code [1] 320308 0
Prevention
Intervention code [2] 325815 0
Lifestyle
Comparator / control treatment
N/A Single group pre-test and post-test design
Control group
Uncontrolled

Outcomes
Primary outcome [1] 327219 0
Reach measured as:
a) Percentage uptake among eligible families determined by study records
b) Representativeness of participants for Victorian ALL population as compared to Victorian state cancer registry
Timepoint [1] 327219 0
Measured at the end of the trial
Primary outcome [2] 327220 0
Effectiveness measured as:
a) Satisfaction with the clinical intervention measured via the Client Satisfaction Questionnaire (CSQ-8)
b) Experience of clinical care utilising a study specific Experience of Care Survey
Timepoint [2] 327220 0
Measured post telehealth 1 and post telehealth 2.
Primary outcome [3] 334937 0
Adoption measured as:
a) Participation rates determined from study records of number of families approached.
b) Number of staff trained in Emerge delivery as determined from completion of the delegation log
Timepoint [3] 334937 0
Measured at the end of the trial.
Secondary outcome [1] 394271 0
Implementation measured as:
a) Acceptability, appropriateness and feasibility as rated by healthcare providers utilising the Acceptability of Intervention Measure (AIM), Intervention Appropriateness Measure, and the Feasibility of Intervention Measure questionnaire (FIM)
b) Percentage of survivorship care plans provided as documented in study records
c) Adherence (uptake of recommendations/referrals) as reported in study surveys
d) Percentage of participants who complete 2 telehealth sessions as documented in study records
Timepoint [1] 394271 0
AIM, IAM, FIM survey will be administered at baseline and 12 months. Care plans, adherence and trial participation will be measured at end of the trial.
Secondary outcome [2] 394272 0
Maintenance measured as:
a) Administration time per patient as documented in study records
b) Length of consultations as documented in study records
c) Time spent on follow up (referrals, information packs, data entry, etc.) as documented in study records
Timepoint [2] 394272 0
Measured post telehealth 1 and post telehealth 2
Secondary outcome [3] 422512 0
Acceptability of the telehealth platform (from the perspective of families and healthcare providers) will be evaluated as part of the study specific survey and attendance rates,
Timepoint [3] 422512 0
Measured post telehealth 1 and post telehealth 2
Secondary outcome [4] 422513 0
Semi-structured qualitative interviews will be conducted in a subset (n=20) of trial participants to determine acceptability of the model.
Timepoint [4] 422513 0
Measured post telehealth 2 for trial participants.
Secondary outcome [5] 422518 0
Semi-structured qualitative interviews will be conducted in a subset (n=15) of stakeholders (healthcare clinicians and champions) to explore the constructs of: Outer setting, Inner Setting, Characteristics of Individuals and Process.
Timepoint [5] 422518 0
Measured at 12-18 months following commencement of trial for stakeholders.
Secondary outcome [6] 422519 0
Clinical effectiveness of the Emerge intervention will be determined by change in unmet information needs for patients 16 years and older measured by a study specific Information Needs Survey.
Timepoint [6] 422519 0
Measured at baseline, post telehealth 1 and post telehealth 2.
Secondary outcome [7] 422520 0
Clinical effectiveness of the Emerge intervention will be determined by change in unmet information needs for parent caregivers measured by a study specific Information Needs Survey.
Timepoint [7] 422520 0
Measured at baseline, post telehealth 1 and post telehealth 2
Secondary outcome [8] 422521 0
Health economic analyses will be undertaken by calculating quality adjusted life years using a composite of the Child Health Utility Index (CHU9D) and the Australian Quality of Life Instrument (AQoL 4D).
Timepoint [8] 422521 0
Measured pre-intervention, post telehealth 2 and at 12 months following end of treatment.
Secondary outcome [9] 422522 0
Health economic analyses will be undertaken by analysis of intervention metrics (e.g., time taken to deliver intervention, number of patient contacts, healthcare utilisation) collected via study records.
Timepoint [9] 422522 0
Measured at the end of the trial.

Eligibility
Key inclusion criteria
Inclusion criteria for the patient participant group include:
- Aged between 2 and 18 years at the time of enrolment.
- Diagnosed with ALL or LLy.
- Received oncology treatment at the RCH or MCH.
- In the final 4 months of maintenance treatment or has completed treatment within the last 6 months.


Inclusion criteria for the parent/caregiver group include:
• Parent/caregiver of a patient aged between 2 to 18 years who has been treated for ALL/LLy at either the RCH or MCH and is in the maintenance phase or has completed treatment.

Inclusion criteria for clinical stakeholder group include:
• Medical, nursing, social work, allied health, mental health or paediatric integrated cancer service (PICS) staff who work with children treated for ALL/LLy and their families at either the RCH or MCH.
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria for the patient group include:
• Diagnosed with another form of cancer
• Relapsed or refractory disease
• Receiving end-of-life treatment

Exclusion criteria for the parent/caregiver group include:
• Parent/caregiver of a child with another form of cancer or who has relapsed or refractory disease and/or is receiving end-of-life treatment.

Exclusion criteria for clinical stakeholder group include:
• Medical, nursing, social work, allied health, mental health or PICS staff who do not work directly with paediatric patients with leukaemia.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
N/A
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
N/A
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
This implementation study will use a mixed-methods approach to develop and evaluate the eHealth end-of-treatment survivorship model of care. A pragmatic hybrid, non-randomised controlled trial will be utilised. A hybrid design advances knowledge of both the intervention and the implementation factors associated with integration into clinical practice. This study is guided by the RE-AIM framework which theorises that the impact of an intervention is a function of five systems based on socio-ecological factors: Reach, Efficacy, Adoption, Implementation and Maintenance. The proposed method is desirable as randomising children and families to either receive this model of care or not, is considered unethical given the known needs and gaps in service provision for this population of patients. This design is also advantageous in providing the ability to undertake research in real world settings, whilst expediting the translation of findings into clinical practice.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The RCH and MCH collectively treat approximately 70 children annually who are diagnosed with ALL and who are aged 2-18 years. Given that around 15% of these patients may be palliative or die, and recruitment will occur over an 18–24-month period, we anticipate recruitment of approximately 100 families over the course of the project (allowing for some families opting not to participate and some withdrawals due to disease recurrence).

Feasibility and acceptability of the model will be assessed by calculating recruitment and participation rates, acceptability ratings by clinical staff and parents/patient satisfaction measured post intervention (e.g., length, content, information).

Descriptive statistics will be utilised to report sample characteristics and for all quantitative measures. Intention to treat will be utilised to analyse primary outcome measures (information needs and stress ratings).
Change between time-points in information needs and stress ratings will be analysed using paired t-tests, following log or square-root transformation to accommodate anticipated positive skew. In order to detect a clinically meaningful change from baseline of 0.3 of a standard deviation, with 80% power and error rate a = 0.05, a sample size of N=100 is required. With an expected attrition rate of 10%, we will aim to recruit minimally 112 cases. Univariate and multivariate analyses will be used to identify psychosocial, demographic and treatment related variables associated with child and parent information needs and stress ratings. With a sample of N=100 (80% power, a = 0.05), we will be powered to detect a medium size of effect (f2=0.15) in multiple linear regression models with up to 5 predictors. Secondary outcomes such as uptake/adherence to recommendations will be calculated (frequencies and percentages).

The assessment of costs will reflect the resources required for program delivery (as reflected by the type of practitioner involved in the delivery of the program and the time required) and the impact on subsequent healthcare service use (as reported from Medicare data and patient information for psychology services). Costs will be reported on the basis of total and average costs per patient for program delivery, subsequent health care use and overall. Program consequences will be expressed in terms of the impact on unmet needs, satisfaction and quality adjusted life years (QALYs, as separate outcomes).

Implementation interviews will be analysed deductively using the Consolidated Framework for Implementation Research (CFIR) to inform these analyses. Interview data will also be analysed inductively to identify novel or emerging data. De-identified interview transcripts will be imported into NVivo 12 software for coding and analysis. Two members of the Emerge research team will code initial interviews independently using line-by-line coding. These initial codes with be compared and a draft coding scheme will be developed which will be discussed and finalised with the research team. The remaining interviews will be coded using this schema. Parent and healthcare provider interviews will be analysed separately.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
7/11/2022
Date of last participant enrolment
Anticipated
30/04/2025
Actual
Date of last data collection
Anticipated
3/11/2025
Actual
Sample size
Target
100
Accrual to date
62
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 19158 0
The Royal Childrens Hospital - Parkville
Recruitment hospital [2] 19159 0
Monash Children’s Hospital - Clayton
Recruitment postcode(s) [1] 33728 0
3052 - Parkville
Recruitment postcode(s) [2] 33729 0
3168 - Clayton

Funding & Sponsors
Funding source category [1] 308174 0
Government body
Name [1] 308174 0
Victorian Cancer Agency
Country [1] 308174 0
Australia
Primary sponsor type
Other Collaborative groups
Name
The Murdoch Children's Research Institute
Address
Royal Children's Hospital
Flemington Road, Parkville
Victoria 3052
Country
Australia
Secondary sponsor category [1] 308951 0
None
Name [1] 308951 0
N/A
Address [1] 308951 0
N/A
Country [1] 308951 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 308159 0
The Royal Children's Hospital
Ethics committee address [1] 308159 0
Ethics committee country [1] 308159 0
Australia
Date submitted for ethics approval [1] 308159 0
10/02/2022
Approval date [1] 308159 0
30/08/2022
Ethics approval number [1] 308159 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 109742 0
A/Prof Maria McCarthy
Address 109742 0
The Royal Children's Hospital, 50 Flemington Road Parkville Victoria 3052
Country 109742 0
Australia
Phone 109742 0
+61 393456866
Fax 109742 0
Email 109742 0
maria.mccarthy@rch.org.au
Contact person for public queries
Name 109743 0
Maria McCarthy
Address 109743 0
The Royal Children's Hospital, 50 Flemington Road Parkville Victoria 3052
Country 109743 0
Australia
Phone 109743 0
+61 393456866
Fax 109743 0
Email 109743 0
maria.mccarthy@rch.org.au
Contact person for scientific queries
Name 109744 0
Maria McCarthy
Address 109744 0
The Royal Children's Hospital, 50 Flemington Road Parkville Victoria 3052
Country 109744 0
Australia
Phone 109744 0
+61 393456866
Fax 109744 0
Email 109744 0
maria.mccarthy@rch.org.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
• De-identified participant data
• Study protocol, Statistical Analysis Plan, PICF and interview/focus group question guide
When will data be available (start and end dates)?
Beginning 6 month/s following analysis and article publication. No end date.
Available to whom?
Future researchers from a recognised research institution whose proposed use of the data has been ethically reviewed and approved by an independent committee and who accept RCH’s conditions for access.
Available for what types of analyses?
Data will be made available long-term for use
How or where can data be obtained?
A/Prof Maria McCarthy will be the long-term custodian of this study’s data. A/P McCarthy can be contacted at maria.mccarthy@rch.org.au


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
19320Study protocol  maria.mccarthy@rch.org.au This can be obtained by contacting A/P McCarthy at... [More Details]
19321Statistical analysis plan  maria.mccarthy@rch.org.au This can be obtained by contacting A/P McCarthy at... [More Details]
19322Informed consent form  maria.mccarthy@rch.org.au This can be obtained by contacting A/P McCarthy at... [More Details]
19323Other  maria.mccarthy@rch.org.au This can be obtained by contacting A/P McCarthy at... [More Details]



Results publications and other study-related documents

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