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Trial registered on ANZCTR


Registration number
ACTRN12619000734167
Ethics application status
Approved
Date submitted
7/05/2019
Date registered
16/05/2019
Date last updated
24/04/2020
Date data sharing statement initially provided
16/05/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Engaging childhood cancer survivors: An implementation trial of a nurse-led, oncologist-supported, preventative program for childhood cancer survivors.
Scientific title
Engaging childhood cancer survivors: An implementation trial of a nurse-led, oncologist-supported, preventative program for childhood cancer survivors.
Secondary ID [1] 297194 0
Nil Known
Universal Trial Number (UTN)
-
Trial acronym
-
Linked study record
-

Health condition
Health condition(s) or problem(s) studied:
Pediatric Cancer 311245 0
Condition category
Condition code
Cancer 309865 309865 0 0
Children's - Other
Cancer 311124 311124 0 0
Children's - Leukaemia & Lymphoma
Cancer 311125 311125 0 0
Children's - Brain
Public Health 311294 311294 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This project is a Type II Hybrid implementation-effectiveness study aimed at evaluating a nurse-led, distance-delivered intervention for survivors who have become disengaged with their cancer follow-up. Engage offers childhood cancer survivors a novel and low-burden intervention to identify their risk factors and improve their physical and emotional health. It involves two nurse-led consultations to facilitate access to care for survivors. Engage is a synchronous, i.e. ‘live’, intervention with the option of being delivered online or alternatively by telephone if requested. Participants will be survivors over 16 years, and parents of survivors who are under 16 years of age. Parents of 16-18 year old survivors may participate in the study 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 will involve:
1. An online or telephone consultation with a clinical nurse consultant (CNC) to collect the survivor’s medical/lifestyle history and assess risk factors (e.g. barriers to care), expected to last approximately 60 minutes.
2. Medical case review by a specially constituted multi-disciplinary team to determine an appropriate referral pathway for a specific medical consultant/s (e.g. a pediatric oncologist, an adult oncologist, a survivorship nurse, a general practitioner, a psychologist, a social worker)
3. A second online or telephone consultation with the CNC to provide medical case review feedback, referral to specialists, a personalised survivorship care plan, and review foreseeable barriers to adherence. In the care plan, participants will be provided with their cancer treatment history and recommendations for ongoing surveillance for late effects. Adherence will be measured through follow-up questionnaires of participants' engagement in recommendations made by the MDT (e.g. get a blood test) and lifestyle and other preventative health behaviours (e.g. to stop smoking). We may also access medical records to assess ongoing attendance at clinic. The second consultation is expected to last up to 30 minutes, depending on the nature and number of recommendations for the participant.

The first and second consultation will occur one to two months apart, dependent on the availability of the multidisciplinary team to meet, and participant availability for the second consultation.

Participants will be invited to complete a questionnaire prior to the intervention and questionnaires at four intervals subsequent to the delivery of the intervention: 1, 6, 12 and 24 months.
Intervention code [1] 313452 0
Behaviour
Intervention code [2] 313453 0
Lifestyle
Intervention code [3] 313454 0
Early detection / Screening
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 318816 0
Health-Related Self-Efficacy
Self-reported health-related self-efficacy using an 8-item Cancer Self Efficacy measure. We developed the Cancer Self Efficacy measure based on a validated 3-item General Health Self Efficacy measure.(21) The original General Health Self Efficacy tool measures survivors’ beliefs in their sense of control over their environment and behaviour. We added 5 additional purpose designed questions to capture self-efficacy and confidence in obtaining the health care that childhood survivors more specifically require, creating an 8-item measure. Our new Cancer Self-Efficacy measure also assesses survivors’ confidence in their knowledge about their type of cancer, the treatment they had received and their risk of late effects as well as their ability to recognise signs of recurrence and find a healthcare professional that meets their needs. Response options are on a Likert-type scale and range: (0) not confident, (1) confident, (2) very confident. These can be summed to create a total score where a higher total score indicates greater self-efficacy.
Timepoint [1] 318816 0
Baseline and Post-intervention (1, 6, 12 and 24 months), where post-intervention is calculated from the time from the second consultation with the CNC.
Primary outcome [2] 318817 0
Intervention Feasibility measured via patient uptake, engagement and retention in the program, This will be assessed using:
Feasibility of the intervention (composite outcome), assessed using:
• Number of participants who complete the intervention, through to the second consultation.
• Number of participants who complete one month follow up survey
• Number of participants who complete six month follow up survey
• Number of participants who complete twelve month follow up survey
• Number of participants who complete twenty-four month follow up survey
• Number of times a participant re-schedules a consultation
• Attrition rate for the study/number of participants lost to follow up
• The average consultation length
• Cost of the intervention per participant (i.e. measured via time [in hours] spent per participant/patient, number of follow-up calls, time of calls [in mins], MDT hours, number of consultations and duration, number of calls made overall [invitation, scheduling consultations, follow-up at each stage, other issues], number of packages sent via post, printing and postage costs, time spent on MDT summaries and final letters, CNC's time spent on letters and patient notes e.g. producing or updating treatment summary/care plan, and time taken to complete intervention)
Timepoint [2] 318817 0
Post-consultation only. This outcome will be assessed after the participant's final survey has been returned, or once the participant has been lost to follow-up.
Secondary outcome [1] 366134 0
Health care use measured using:
History of consultations with various health professionals (including, but not limited to, cardiologist, endocrinologist, fertility specialist, neurologist, dentist, oncologist). At baseline, participants are asked whether they have seen each health professionals since completing cancer treatment (yes/no), and how often they have seen them (open response), At surveys 1, 6, 12 and 24 months post-baseline, participants are asked if they received a recommendation to see any of these health professionals (yes/no), what the recommendation was (e.g., see dentist bi-annually), whether they did what was recommended (1 no; 2: no, I'm planning to; 3: yes) and whether they found the recommendation useful (yes/no).
Timepoint [1] 366134 0
Baseline and Post-intervention (1, 6, 12 and 24 months), where post-intervention is calculated from the time after the second consultation with the CNC.
Secondary outcome [2] 369858 0
Adherence to recommended guidelines: Participants will be invited in the post-consultation survey to report on the cancer-related recommendations they received, for example to visit a psychologist or to quit smoking. The Clinical Nurse Consultant will also document the physical and mental health recommendations made by the medical review board and during the second online consultation for each participating survivor. Survivor-listed recommendations will be compared with the Clinical Nurse Consultants recommendations, and assessed for compliance. We may also access medical records to assess attendance at clinic.
Timepoint [2] 369858 0
Post-consultation only. This outcome will be assessed after the participant's final survey has been returned, or once the participant has been lost to follow-up.
Secondary outcome [3] 369859 0
Health behaviours and lifestyle: sun protection behaviours. This outcome is based on previously implemented questionnaires, and selected as childhood cancer survivors are at increased risk of skin cancer(s). Inclusion of this measure also enables comparison with Australian normative data, collected by the Australian Bureau of Statistics. • Sun protection behaviours (ranging 1: “Never” to 5 “Always”)
Timepoint [3] 369859 0
Baseline and Post-intervention (1, 6, 12 and 24 months), where post-intervention is calculated from the time after the second consultation with the CNC
Secondary outcome [4] 369860 0
Emotional wellbeing
A validated emotion thermometer, assessing participant’s emotional wellbeing (depression, anxiety, anger, and distress, ranging 1:“None” to 10:“Extreme”) and need for help (ranging, 1:“Can manage by myself” to 10“Desperately need help”).
Timepoint [4] 369860 0
Baseline and Post-intervention (1, 6, 12 and 24 months), where post-intervention is calculated from the time after the second consultation with the CNC
Secondary outcome [5] 369861 0
Quality of life.
A validated, six-item, quality of life measure, the EQ-5D-5L. These items assess mobility, self-care, and ability to participate in usual activities (each ranging 1:“No problems”, to 5:“I am unable to”), as well as pain/discomfort, and anxiety/depression (each ranging, 1: “None” to 5: “Extreme”). Each item focuses on the participant’s current feelings about these sub-scales. The EQ-5D-5L has good reliability and validity.
In the parent (for survivors 17 years and under) versions of the survey, the validated, nine-item Child Health Utility 9D measure will be used to assess children’s health related quality of life, outlining any problems with schoolwork, sleep, daily routine (ranging, 1: “No problems” to 5: “Can’t do”) and ability to join activities (ranging, 1: “Can join in with any” to 5: “Can join in with no”). Parents will be asked to assess how worried, sad, tired, annoyed (ranging, 1: “Doesn’t feel” to 5 “Feels very”) and in pain (ranging, 1: “Doesn’t have any pain” to 5: “Has a lot of pain”) their child is on that day.
Timepoint [5] 369861 0
Baseline and Post-intervention (1, 6, 12 and 24 months), where post-intervention is calculated from the time after the second consultation with the CNC
Secondary outcome [6] 369862 0
Survivors' information needs will be assessed using a 4-item cancer-related information needs scale (composite outcome), with an additional 4 items added (ranging 1:“Not needed” to 3:“Needed and received enough”). Overall, the measure addresses the following information areas: cancer diagnosis, treatment(s) received, follow-up care needed, late effects risks, personal and familial cancer risks, fertility, Vitamin D, and second cancer risk
Timepoint [6] 369862 0
Baseline and Post-intervention (1, 6, 12 and 24 months), where post-intervention is calculated from the time after the second consultation with the CNC
Secondary outcome [7] 369863 0
GP healthcare use, measured by self-reported regularity of General Practitioner (GP) visits, or the reason(s) for not seeing a regular GP.
Timepoint [7] 369863 0
Baseline and Post-intervention (1, 6, 12 and 24 months), where post-intervention is calculated from the time after the second consultation with the CNC
Secondary outcome [8] 369864 0
Health behaviours and lifestyle: diet.
This outcome is based on previously implemented questionnaires. Inclusion of this measure enables comparison with Australian normative data, collected by the Australian Bureau of Statistics
Eating habits including weekly intake of major food groups (ranging 1: “Not at all” to 4: “Every day”, exercise in hours over the last week)
Timepoint [8] 369864 0
Baseline and Post-intervention (1, 6, 12 and 24 months), where post-intervention is calculated from the time after the second consultation with the CNC
Secondary outcome [9] 369865 0
Health behaviours and lifestyle: alcohol consumption. This outcome is based on previously implemented questionnaires. Inclusion of this measure enables comparison with Australian normative data, collected by the Australian Bureau of Statistics.
Alcohol consumption (ranging, 1: “Never/given up”, to 2:“Current” to 3: “Regularly”). If "regularly" participants are asked to specify average number of standard drinks per week.
Timepoint [9] 369865 0
Baseline and Post-intervention (1, 6, 12 and 24 months), where post-intervention is calculated from the time after the second consultation with the CNC
Secondary outcome [10] 369866 0
Health behaviours and lifestyle: recreational drug use. This outcome is based on previously implemented questionnaires. Inclusion of this measure enables comparison with Australian normative data, collected by the Australian Bureau of Statistics.
Recreational drug use (Yes/No) and frequency if applicable (ranging, 1: “Less often” to 4: “Most days”). Participants are asked to specify recreational drug(s) used.
Timepoint [10] 369866 0
Baseline and Post-intervention (1, 6, 12 and 24 months), where post-intervention is calculated from the time after the second consultation with the CNC
Secondary outcome [11] 369867 0
Health behaviours and lifestyle: history of skin damage. This outcome is based on previously implemented questionnaires, and selected as childhood cancer survivors are at increased risk of skin cancer(s). Inclusion of this measure also enables comparison with Australian normative data, collected by the Australian Bureau of Statistics.
History of sunburn and clinical skin examinations (ranging 1: “Never” to 5: “5 times or more”)
Timepoint [11] 369867 0
Baseline and Post-intervention (1, 6, 12 and 24 months), where post-intervention is calculated from the time after the second consultation with the CNC
Secondary outcome [12] 369868 0
Lifestyle change beliefs (composite outcome):
Participant’s belief about whether changes in their lifestyle can improve their physical health (1: disagree; 1: agree a little, 3: totally agree).
Participant’s belief about whether changes in their lifestyle can improve their mental health (1: disagree; 1: agree a little, 3: totally agree).
Timepoint [12] 369868 0
Baseline and Post-intervention (1, 6, 12 and 24 months), where post-intervention is calculated from the time after the second consultation with the CNC
Secondary outcome [13] 369869 0
Self-reported health rating:
Participant’s rating of their health ‘today’ (ranging, 0:“The worst health I can imagine” to 100:“The best health I can imagine”).
Timepoint [13] 369869 0
Baseline and Post-intervention (1, 6, 12 and 24 months), where post-intervention is calculated from the time after the second consultation with the CNC

Eligibility
Key inclusion criteria
Study inclusion criteria are defined as any individual who:
i) is over the age of 16;
ii) was diagnosed with a form of cancer prior to 18 years of age;
iii) was diagnosed at least 5 years prior to study participation;
iv) was treated for cancer at one of the participating hospitals;
v) has completed active cancer treatment; and
vi) is alive and in remission at the time of study participation;
vii) Parents of survivors less than 18 years who meet the above criteria may also be eligible to participate.
Minimum age
16 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
-individuals with insufficient English language skills to complete the questionnaire
- Individuals who in the opinion of the nurse or oncologist would be unsuitable for the study (e.g. severe mental health difficulties, severe language or cognitive limitations)
- Individuals not capable of providing fully informed consent due to any psychiatric or cognitive difficulties
Survivors who are not eligible for the intervention will be offered a face-to-face clinic appointment instead.

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
-
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
Based on calculations from our pilot data, a sample of 70 survivors will provide approximately 90% power to detect such a change using a two-sided significance level of 5%.

We will use descriptive statistics (proportions, means, SD, medians) as appropriate to report sample characteristics. To evaluate the change in the primary outcome over time (i.e. the impact of Engage on self-efficacy), we will use a mixed-effects cumulative logistic regression model, with random intercepts per individual and fixed effects for the time points and individual scale items. By using the fitted values from the model, we will also be able to estimate the expected change over time in the number of responses falling in each category as well as in the overall health-related self-efficacy score. This analysis allows evaluation of longitudinal data in the case where missing data exists.

We will measure the implementation outcomes based on our team’s previous interventions. Specifically, we will measure feasibility as at least a 70% recruitment rate, and no more than 30% drop out after enrolment (i.e. 70% engagement and retention at the completion of the program). These outcomes will be presented as estimated rates with two-sided 95% confidence intervals.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 12984 0
Sydney Children's Hospital - Randwick
Recruitment postcode(s) [1] 25464 0
2031 - Randwick

Funding & Sponsors
Funding source category [1] 301747 0
Charities/Societies/Foundations
Name [1] 301747 0
Kids Cancer Allance
Address [1] 301747 0
Kids Cancer Alliance, Children's Cancer Institute, Lowy Cancer Research Centre, UNSW, NSW, 2031
Country [1] 301747 0
Australia
Funding source category [2] 301753 0
Charities/Societies/Foundations
Name [2] 301753 0
Cancer Council NSW
Address [2] 301753 0
153 Dowling St, Woolloomooloo NSW 2011
Country [2] 301753 0
Australia
Funding source category [3] 302716 0
Charities/Societies/Foundations
Name [3] 302716 0
Cancer Council NSW
Address [3] 302716 0
153 Dowling St, Woolloomooloo NSW 2011
Country [3] 302716 0
Australia
Primary sponsor type
University
Name
UNSW Sydney
Address
Barker Street
Kensington, NSW, 2031
Country
Australia
Secondary sponsor category [1] 302551 0
None
Name [1] 302551 0
Address [1] 302551 0
Country [1] 302551 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 302470 0
Sydney Children's Hospital Network Human Research Ethics Committee.
Ethics committee address [1] 302470 0
Corner Hawkesbury Road
and Hainsworth Street
Locked Bag 4001
Westmead NSW 2145
Ethics committee country [1] 302470 0
Australia
Date submitted for ethics approval [1] 302470 0
29/01/2019
Approval date [1] 302470 0
09/04/2019
Ethics approval number [1] 302470 0
2019/ETH00126

Summary
Brief summary
The purpose of this study is to determine if a nurse-led, distance-delivered, intervention called ‘Engage’ can be used to increase childhood cancer survivors' self-efficacy, and improve their long-term physical and mental health by promoting engagement in survivorship care.

Who is it for?
You may be eligible if you are over the age of 16 and were treated for cancer at least 5 years prior to participation in this study, or you may be eligible if you are a parent of a cancer survivor who is less than 18 years old.

Study details
All participants in this study will receive two online or telephone consultations with a clinical nurse consultant, and a medical case review with a multidisciplinary team. The purpose of these consultations is to provide a referral pathway, and survivorship care plan.
Participants will also need to complete four questionnaires at 1, 6, 12 and 24 months.

How will this research contribute to childhood cancer survivors?
It is hoped that this intervention will be used to improve the quality of life of childhood cancer survivors and reduce pressure on healthcare services associated with managing treatment-related late effects.
Trial website
https://www.behaviouralsciencesunit.org/engage.html
Trial related presentations / publications
Public notes
Oral presentations
Signorelli, C., Wakefield, C.E., Fardell, J.E., McLoone, J.K, Jones, J.M, Cohn., R.J., on behalf of the ANZCHOG Survivorship Study Group. Re-engaging ‘dis-engaged’ childhood cancer survivors: overcoming barriers to long term follow-up care with innovative models of survivorship care. Oral presentation at the Victorian Comprehensive Cancer Centre Survivorship Conference October 13-14th 2016, Melbourne.

Poster presentations:
Signorelli, C. Wakefield, CE., Fardell, JE., Johnston, KA., Brierley, M.E., & Cohn, RJ., ‘Re-engage’: a targeted intervention designed to overcome survivor-reported barriers to long term follow-up care in paediatric cancer. Poster presentation at the Victorian Comprehensive Cancer Centre Survivorship Conference February 8-9, 2018 Melbourne.

Signorelli, C., Wakefield, CE., Fardell, JE., Johnston, KA., Brierley, M.E., Cohn, RJ. on behalf of the ANZCHOG Survivorship Study Group. Re-engaging ‘dis-engaged’ childhood cancer survivors: an innovative solution to overcome barriers to long term follow-up care. Poster presentation at the KCA Symposium, 1st December 2017, Sydney

Contacts
Principal investigator
Name 90330 0
Dr Christina Signorelli
Address 90330 0
Kids Cancer Centre, Level 1 South, Sydney Children's Hospital, High St, Randwick, NSW, 2031.
Country 90330 0
Australia
Phone 90330 0
+61 2 9382 5554
Fax 90330 0
Email 90330 0
c.signorelli@unsw.edu.au
Contact person for public queries
Name 90331 0
Dr Christina Signorelli
Address 90331 0
Kids Cancer Centre, Level 1 South, Sydney Children's Hospital, High St, Randwick, NSW, 2031.
Country 90331 0
Australia
Phone 90331 0
+61 2 9382 5554
Fax 90331 0
Email 90331 0
c.signorelli@unsw.edu.au
Contact person for scientific queries
Name 90332 0
Dr Christina Signorelli
Address 90332 0
Kids Cancer Centre, Level 1 South, Sydney Children's Hospital, High St, Randwick, NSW, 2031.
Country 90332 0
Australia
Phone 90332 0
+61 2 9382 5554
Fax 90332 0
Email 90332 0
c.signorelli@unsw.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
No, individual participant data will not be available. Output will be disseminated in peer reviewed publications by the research team.
What supporting documents are/will be available?
No other documents available
Summary results
No Results