Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000590864
Ethics application status
Approved
Date submitted
18/12/2020
Date registered
18/05/2021
Date last updated
27/09/2023
Date data sharing statement initially provided
18/05/2021
Date results information initially provided
27/09/2023
Type of registration
Retrospectively registered

Titles & IDs
Public title
Engage: A novel multidisciplinary intervention to engage childhood brain cancer survivors
Scientific title
Engage: An effectiveness-implementation study of a novel multidisciplinary intervention evaluating childhood brain cancer survivors' health-related self-efficacy and quality of life
Secondary ID [1] 302284 0
None
Universal Trial Number (UTN)
N/A
Trial acronym
N/A
Linked study record
The record, ACTRN12619000734167 is the pilot study to this trial. The record, ACTRN12619000734167 is the sister study to this trial – it is responsible for recruiting all childhood cancer survivors, while this trial is recruiting just childhood brain cancer survivors.

Health condition
Health condition(s) or problem(s) studied:
Paediatric Brain Cancer 319937 0
Condition category
Condition code
Cancer 317873 317873 0 0
Children's - Brain
Public Health 318032 318032 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This project is a Type II Hybrid effectiveness-implementation study aimed at evaluating a nurse-led, distance delivered intervention for survivors of childhood brain cancer who have become disengaged with their cancer follow-up.

The Engage program will offer ‘disengaged’ survivors of childhood brain cancer (i.e. survivors who have not received specialist survivorship care in the past 2 years), a remotely delivered multidisciplinary case review to identify their risk factors and improve their physical and emotional health.

Engage is a synchronous, i.e. ‘live’, intervention with the option of being delivered online using videoconferencing or alternatively by telephone if requested. Participants will be survivors who were diagnosed with brain cancer prior to the age of 18. For participants aged 14 or younger, parents of survivors will participate instead of the survivor. The most appropriate party (survivor or parent) to participate is at the decision of the family in discussion with the Clinical Nurse Consultant and based on the maturity of the young adult and family preferences.

The intervention involves four components:
1. An online, ‘live’, consultation with a clinical nurse consultant (CNC) specializing in childhood cancer survivorship, to collect the patients’ medical history and assess their personal risk factors. The anticipated duration of the initial ‘live’ consultation with a clinical nurse consultant is 40 to 60 minutes. The ‘e-Health management tool’ has been replaced by an online survey about the survivor’s health and a nurse consultation conducted via zoom. All digital components of the study or e-health use is on an as-needs basis (i.e. dependent on how long it takes to complete the questionnaire or how long the survivor would like to talk to the nurse).
2. Medical case review by a multi-disciplinary team (MDT) specializing in cancer survivorship to determine tailored recommendations for each survivor. Recommendations are to address the survivor’s physical and mental health, as well as early intervention/prevention measures such as surveillance schedules and the discussion of positive health behaviours. The MDT will include at a minimum, a pediatric oncologist, general practitioner, survivorship nurse, social worker, or psychologist. Additional panel members may include an adult oncologist, endocrinologist, neurologist, radiation oncologist, and allied health specialists (e.g. occupational therapists, exercise physiology, or physiotherapy).
3. A written treatment summary and MDT summary report will be sent to the survivor and their GP. The detailed report will outline in lay language the survivor’s risk of developing specific late effects and provide tailored recommendations that reflect the survivor’s health care needs and appropriate surveillance schedules.
4. A second online consultation with the CNC will be provided to ensure that the survivor receives education about their cancer treatment, risks, and the MDT’s recommendations for the care of late effects. It will ensure survivors are engaged and empowered to manage their own health and there are no known barriers to prevent their adherence to the MDTs recommendations. The nurse will also focus on the importance of having a regular primary care physician and maintaining positive health behaviors (such as exercise, diet, sunscreen use, and abstaining from smoking, and excessive alcohol consumption/drug use). The consultation is expected to have a duration of approximately 40 to 60 minutes, but this is dependent on the nature and number of recommendations provided to the participant.
5.A brief booster session will be provided by the CNC 3-months after the MDT review. It will discuss the survivor’s adherence to recommendations and troubleshoot any barriers to care.

Participants will also be invited to complete a questionnaire 1 week prior to the intervention (T1), followed by follow-up questionnaires at 1 month, 6 months, 12 months and 24 months (T2, T3, T4, T5).

Adherence will be monitored in a number of ways. In terms of adherence to the intervention’s delivery, all nurse consults will be audio recorded and transcribed verbatim by a professional transcription service. These transcripts will be coded and independently reviewed to assess intervention fidelity. The nurse will also be required to complete a survey during/after each consultation to report whether or not they adhered to each component of the planned consultation. Consultation length (hours and minutes) will be recorded. Participants’ adherence to the recommendations made by the MDT will be assessed via the research questionnaires (administered at one-, six-, twelve- and twenty-four months post-intervention). The questionnaires will ask the participant whether they have adhered to each individual recommendation, as well as health behaviour guidelines.

As well as analyzing the effectiveness of this intervention, we seek to better understand how a clinical intervention such as this is implemented within a hospital setting. As such, our implementation science team will be conducting qualitative interviews with various stakeholders, including hospital management, the clinical team involved in intervention delivery, and participants. This will take a staged approach, initially reflecting on lessons learned from the pilot study, followed by interviews related to the processes necessary to implement the program, and finally, after the completion of the trial, reflections on how to improve future implementation.
Intervention code [1] 319198 0
Prevention
Intervention code [2] 319200 0
Lifestyle
Comparator / control treatment
N/A
Control group
Uncontrolled

Outcomes
Primary outcome [1] 325889 0
To establish clinical effectiveness, there are two primary outcomes for the project:

(1) Self-reported health-related self-efficacy will be assessed using an 8-item Cancer Self Efficacy measure. This was developed through expanding on a valid 3-item General Health Self Efficacy, which originally measured survivor's belief in their sense of control over their environment and behaviour. The 5 additional items were purpose-designed questions to capture self-efficacy and confidence in obtaining the healthcare that childhood brain cancer survivors more specifically require.
Timepoint [1] 325889 0
Follow-ups will occur at the following time points: Baseline (pre-intervention) and at 1 month, 6 months, 12 months (primary timepoint) & 24 months after the second nurse consultation.
Primary outcome [2] 326269 0
(2) Quality of life will be measured by the EQ-5D-5L.
Timepoint [2] 326269 0
Follow-ups will occur at the following time points: Baseline (pre-intervention) and at 1 month, 6 months, 12 months (primary timepoint) & 24 months after the second nurse consultation.
Secondary outcome [1] 389445 0
Implementation outcomes: Acceptability, appropriateness, sustainability and feasibility will be assessed via qualitative interviews with key stakeholders including healthcare professionals involved in the delivery of the program. Fidelity will be assessed by an evaluation of nurse consultations and MDT meetings. We will also assess survivors' program uptake, engagement, and retention rates.
For site-specific context information, we will also collect the following administrative and process data:
i. Number of survivors recruited and any wait times to participate
ii. Composition and attendance and time at each multidisciplinary team meeting.
iii. Duration and fidelity of each nurse consult (i.e. assessing whether Re-engage is being delivered as intended, which will be independently assessed by reviewing recorded Re-engage consults).
iv. Percent of consults for which participants require interpreters.

Cost data will be assessed through health economics analysis on MDT composition (health care professionals present at the MDT, and those contributing either in person or remotely) and timing (time taken to discuss each participant during the MDT in addition to nurse consultation timing).
Timepoint [1] 389445 0
Implementation outcome will be assessed at baseline (pre-intervention) and at 1 month, 6 months, 12 months, and 24 months after the second nurse consultation. The cost consequences of the intervention will only be assessed at the primary end point, i.e. at 12-months after nurse consultation two.
Secondary outcome [2] 390838 0
2) Psychosocial well-being: will be assessed using validated emotion thermometers, approval granted by the tool's author (link to Emotion thermometer tool (see Professor Alex J Mitchell tool - http://www.emotionthermometers.com/)
Timepoint [2] 390838 0
Psychosocial well-being will be assessed at baseline (pre-intervention) and at 1 month, 6 months, 12 months, and 24 months after the second nurse consultation.
Secondary outcome [3] 390839 0
(3) Participation in surveillance programs (e.g. breast or skin screening, cardiac monitoring, neuropsychological assessment, amongst others): This will be assessed through the use of a number of self-reported items indicating whether the survivor has participated in the surveillance program and how long ago. This will be compared to published guidelines defining the appropriate surveillance schedule.
Timepoint [3] 390839 0
Participation in surveillance programs will be assessed at baseline (pre-intervention) and at 1 month, 6 months, 12 months, and 24 months after the second nurse consultation.
Secondary outcome [4] 390840 0
4) Adherence to health behaviour guidelines (including smoking, diet, physical activity, sun protection & alcohol consumption): This will be assessed through the use of a number of self-reported items indicating the extent to which the survivor has participated in each health behaviour, compared to published guidelines defining the appropriate parameters for each health behaviour
Timepoint [4] 390840 0
Adherence to health behaviour guidelines will be assessed at baseline (pre-intervention) and at 1 month, 6 months, 12 months, and 24 months after the second nurse consultation.
Secondary outcome [5] 390841 0
5) Health service utilization (including visits to GPs, specialists, hospitals, use of community support services, and medication usage): This will be assessed through the use of a number of self-reported items indicating the extent to which the survivor has used each service.
Timepoint [5] 390841 0
Health service utilisation will be assessed at baseline (pre-intervention) and at 1 month, 6 months, 12 months, and 24 months after the second nurse consultation.
Secondary outcome [6] 390842 0
6) Participation in survivorship care: This will be assessed through the use of a self-reported item indicating the extent to which the survivor has participated in survivorship care in the past 12 months.
Timepoint [6] 390842 0
Participation in survivorship care will be assessed at baseline (pre-intervention) and 12 months, and 24 months after the second nurse consultation.
Secondary outcome [7] 390843 0
7) The perceived benefits and barriers of participating in the Re-engage intervention, including satisfaction with Re-engage assessments and satisfaction with nurse consultations: This will be assessed through the use of purpose-developed self-report items.
Timepoint [7] 390843 0
This will be assessed at 1 month after the second nurse consultation.
Secondary outcome [8] 390844 0
8) The length of time taken to complete the questionnaires, benefits, and burdens of participation (all questionnaires) will also be documented: This will be assessed through use of computer metrics.
Timepoint [8] 390844 0
This will be assessed at baseline (pre-intervention) and at 1 month, 6 months, 12 months, and 24 months after the second nurse consultation.

Eligibility
Key inclusion criteria
Study inclusion criteria are defined as any individual who:
i) Was diagnosed with a brain cancer* prior to age 18 years (the survivor may currently be any age**);
ii) Was diagnosed with brain cancer more than 5 years prior to study participation (i.e. they have entered long term survivorship);
iii) Was treated for brain cancer at one of the participating hospitals (Sydney Children’s Hospital, The Children’s Hospital at Westmead, and Perth Children’s Hospital);
iv) Has completed active treatment, is alive and in remission at the time of study participation; and
v) Has not received specialist survivorship care in the past 18 months***.
vi) Provides a referral letter from their GP, addressed to the lead specialist of the MDT (as would be the case in all instances where a specialist is requested to provide clinical care).

Note:
* Brain cancer is defined as any central nervous system tumour, including but not limited to intracranial tumours. Both low- and high-grade brain cancers will be eligible for inclusion. Survivors who have experienced cancer recurrence after their first brain cancer diagnosis will remain eligible, as long as they have completed treatment for the recurrence with curative intent before their first consultation with the nurse.

** For survivors who are aged 14 years or younger, we will request the parent participate on their behalf. For survivors aged between 14-18 years of age, they or their parent(s), may participate in the study, based on the maturity of the young adult and family preferences. For all minors (<18 years of age), parents will be approached via the Parent Invitation Letter, and encouraged to provide the accompanying Survivor Invitation Letter and Survivor Information Sheet to their child in order to jointly make a decision around participation.

*** “Has not received specialist survivorship care” will be defined as a survivor who has not received care from an oncologist with survivorship expertise. The survivor will remain eligible for inclusion if they have received cancer-related care from their GP. The survivor will remain eligible for inclusion if they have received cancer-related care from their GP. . Survivors whose specialist survivorship care physician believes they would benefit from further engagement will also be eligible. Survivors who express that they have not received adequate care to address the full spectrum of their medical and psychosocial needs will also be eligible.
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Study exclusion criteria are defined as any individual who:
i) Was first diagnosed with brain cancer when they were over 18 years of age;
ii) Was diagnosed with brain cancer less than 5 years ago;
iii) Is currently receiving active cancer treatment;
iv) Is currently receiving specialist survivorship care from their treating centre;
v) Is currently experiencing severe difficulties that would make participation too burdensome in the clinical opinion of their treating team, or if spontaneously reported by the survivor or their family (e.g. diagnosed with current psychosis, incapacitating alcohol/drug use, suicidal ideation).

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



Intervention assignment
Single group
Other design features
Not applicable.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Quantitative statistical analysis (Clinical Effectiveness):
A sample of 80 survivors will provide greater than 95% power to detect a difference in a least one of the two primary outcomes, for correlations ranging from 0 to 0.8. Furthermore, if the correlation between outcomes is less than 0.5, we estimate that the power to detect differences in both primary outcomes is greater than 90% and remains above 80% even if the correlation is as high as 0.8. To allow for 33% attrition from baseline to post-intervention (based on the observation rate in our pilot), we aim to initially recruit 120 participants for the baseline assessment. With 120 recruited participants at baseline, the maximum margin of error of a 95% confidence interval for the uptake rate will be less than 7%, and for the engagement and retention rates will be less than 9%.

We will conduct statistical analyses using IBM SPSS Statistics (version 24.0). We will use descriptive statistics (proportions, means, SD, medians) as appropriate to report sample characteristics. The change in the primary outcomes (health-related self-efficacy and quality of life) between baseline and post-intervention will be assessed on an intention-to-treat basis using mixed-effects regression models, with random intercepts per individual, and fixed effects for the time points. This analysis allows evaluation of longitudinal data in the case where missing data exists, with the estimate of interest being the average difference in each outcome at 12 months post-intervention (Q4) compared to baseline. To account for the inflated type I error rate resulting from the analysis of two primary outcomes, we will use the Holm–Bonferroni method to perform inference on these comparisons, controlling the family-wise error rate at 5%. We will conduct pre-specified subgroup analyses to investigate possible differential changes over time for particular participant groups (e.g. participants living in rural/remote vs urban/capital city locations). In accordance with CONSORT (1), all missing data will be described in detail. We will perform similar analyses for the secondary outcomes, modified to suit the outcome measure.

Secondary outcomes, such as satisfaction with care, health behaviours, emotional well-being, and need for information related to childhood cancer will be summarised using descriptive statistics, correlations and t-tests.


Qualitative analysis (Implementation):
Phase 1: Qualitative interviews conducted will be recorded and transcribed by a professional transcription services (e.g. TranscriptionAUS) to facilitate analysis. Interviewers will keep a log of the salient content of each interview. Interview data will be deductively analysed according to CFIR domains (intervention characteristics, outer setting, inner setting, process, and characteristics of individuals) and constructs (e.g., intervention characteristics: ‘design and packaging’, ‘complexity’, ‘trialability’, etc.). The analysis will be supported by NVivo16. Two researchers will work independently to double-code a selection of interviews until high inter-rater reliability is reached, with disagreements resolved through discussion.

Phase 2/3: Data collected in phase 1 will be used to a) inform phase 2 prospective interview guides with potential users and HCP delivering Re-engage, and b) to initiate the design of the implementation strategy to be used in the Type II trial (see phase 3). During phase 4, we will re-invite participants to undergo a qualitative interview for evaluation purposes of the implementation strategy.

Interview data will be deductively analysed according to CFIR domains, triangulated with phase 1 data, and the ERIC tool (2) will be used to generate specific targeted implementation techniques (e.g., if ‘complexity’ of Re-engage was identified as a potential problem, the most appropriate ERIC-recommended techniques include to ‘create an implementation blueprint’, and ‘promote adaptability’, and ‘conduct ongoing training’).

See below for references:
(1) Schulz KF, Altman DG, Moher D. CONSORT 2010 Statement: updated guidelines for reporting parallel group randomised trials. BMC Medicine. 2010;8(1):1-9.
(2) Powell BJ, Waltz TJ, Chinman MJ, et al. A Refined Compilation of Implementation Strategies: Results From the Expert Recommendations for Implementing Change (ERIC) Project. Implement Sci. 2015;10:21.

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
15/06/2021
Actual
17/05/2021
Date of last participant enrolment
Anticipated
31/12/2022
Actual
13/06/2023
Date of last data collection
Anticipated
31/12/2024
Actual
Sample size
Target
120
Accrual to date
Final
78
Recruitment in Australia
Recruitment state(s)
NSW,WA
Recruitment hospital [1] 18135 0
Sydney Children's Hospital - Randwick
Recruitment hospital [2] 18136 0
Perth Children's Hospital - Nedlands
Recruitment hospital [3] 18137 0
The Children's Hospital at Westmead - Westmead
Recruitment postcode(s) [1] 32128 0
2031 - Randwick
Recruitment postcode(s) [2] 32129 0
6009 - Nedlands
Recruitment postcode(s) [3] 32130 0
2145 - Westmead

Funding & Sponsors
Funding source category [1] 306710 0
Government body
Name [1] 306710 0
Medical Research Future Fund - Australian Brain Cancer Mission (Funding Body: Department of Health, The Australian Government)
Country [1] 306710 0
Australia
Primary sponsor type
University
Name
University of New South Wales
Address
Barker Street
Kensington, NSW
Australia 2031
Country
Australia
Secondary sponsor category [1] 307258 0
Hospital
Name [1] 307258 0
Sydney Children's Hospital
Address [1] 307258 0
High St,
Randwick NSW 2031
Country [1] 307258 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 306880 0
The Sydney Children's Hospitals Network Human Research Ethics Committee
Ethics committee address [1] 306880 0
Corner Hawkesbury Road and Hainsworth Street, Locked Bag 4001, Westmead NSW 2145. Sydney, Australia.
Ethics committee country [1] 306880 0
Australia
Date submitted for ethics approval [1] 306880 0
16/10/2020
Approval date [1] 306880 0
03/11/2020
Ethics approval number [1] 306880 0
2020/ETH02434

Summary
Brief summary
The purpose of this study is to determine if a nurse-led, distance-delivered intervention called ‘Re-engage’ can be used in childhood brain cancer survivors to increase health-related self-efficacy, improve their long-term physical and mental health, and quality of life.

Who is it for?
Survivors are eligible if they were diagnosed with a brain cancer (any nervous system tumour) prior to the age of 18 years, and were diagnosed more than 5 years prior to participation in the study. At the time of study participation, survivors may be of any age, however if aged 14 years or younger, parents participate on their behalf. Survivors must have completed active treatment, be in remission and have not received any specialist survivorship care in the past 18 months.

Study details:
This project will offer young ‘disengaged’ survivors of childhood brain cancer who currently access no cancer follow-up care a novel, free, and low burden intervention to identify their risk factors and improve their physical and mental health. All participants in this study will receive two live, online consultations with a clinical nurse consultant, and a medical case review with a multi-disciplinary team. The purpose of these consultations and reviews is to triage and provide referral pathways to appropriate follow-up services. The primary outcome for the trial will be survivors’ self-reported health-related self-efficacy and quality of life. Participants will also need to complete four questionnaires at 1, 6, 12, and 24 months post-intervention.

Despite recommendations for regular medical follow-up, many young survivors do not access any regular cancer-specific follow-up care to address health concerns. Without early intervention, late effects can shorten survivors’ lives and can severely impact quality of life. Critically, many of the health and psychosocial problems childhood brain cancer survivors experience can be prevented or managed better with effective survivorship care.

Summation:
It is hoped that this research will determine whether a novel nurse-led intervention is acceptable to, and enables re-engagement of childhood brain cancer survivors which may lead to improved health outcomes in the longer term.
Trial website
https://www.behaviouralsciencesunit.org/re-engage-brain.html
Trial related presentations / publications
Public notes
‘Re-engage’ pilot study protocol: a nurse-led eHealth intervention to re-engage, educate and empower childhood cancer survivors'
- DOI: 10.1136/bmjopen-2018-022269

'Re-Engage: A Novel Nurse-Led Program for Survivors of Childhood Cancer Who Are Disengaged From Cancer-Related Care'
- DOI: https://doi.org/10.6004/jnccn.2020.7552

Contacts
Principal investigator
Name 105326 0
Prof Claire Wakefield
Address 105326 0
Kids Cancer Centre
Level 1 South
Sydney Children's Hospital
High Street
Randwick 2031 NSW.
Country 105326 0
Australia
Phone 105326 0
+61 425 336 571
Fax 105326 0
+61 2 9382 1789
Email 105326 0
[email protected]
Contact person for public queries
Name 105327 0
Dr Jordana McLoone
Address 105327 0
Kids Cancer Centre
Level 1 South
Sydney Children's Hospital
High Street
Randwick NSW 2031
Country 105327 0
Australia
Phone 105327 0
+61293825554
Fax 105327 0
+61 2 9382 1789
Email 105327 0
[email protected]
Contact person for scientific queries
Name 105328 0
Dr Jordana McLoone
Address 105328 0
Kids Cancer Centre
Level 1 South
Sydney Children's Hospital
High Street
Randwick NSW 2031
Country 105328 0
Australia
Phone 105328 0
+61293825554
Fax 105328 0
+61 2 9382 1789
Email 105328 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
10036Ethical approval    380567-(Uploaded-15-12-2020-11-57-12)-Study-related document.pdf



Results publications and other study-related documents

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