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Trial registered on ANZCTR


Registration number
ACTRN12618000194268
Ethics application status
Approved
Date submitted
25/01/2018
Date registered
7/02/2018
Date last updated
8/01/2020
Date data sharing statement initially provided
8/01/2019
Date results information initially provided
8/01/2020
Type of registration
Retrospectively registered

Titles & IDs
Public title
‘Re-engaging the disengaged’ in childhood cancer survivorship: A pilot study of a nurse-led, oncologist-supported, preventative program
Scientific title
‘Re-engaging the disengaged’ in childhood cancer survivorship: A pilot study assessing the acceptability and feasibility of a nurse-led, oncologist-supported, preventative program
Secondary ID [1] 293735 0
Nil known
Universal Trial Number (UTN)
U1111-1189-0945
Trial acronym
Re-engage
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Paediatric Cancer 306102 0
Condition category
Condition code
Cancer 305225 305225 0 0
Children's - Other
Cancer 305226 305226 0 0
Children's - Leukaemia & Lymphoma
Cancer 305227 305227 0 0
Children's - Brain

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This project is an acceptability and feasibility study aimed at evaluating a nurse-led, distance-delivered intervention for survivors who have become disengaged with their cancer follow-up. Re-engage offers young ‘disengaged’ survivors who currently access no cancer follow up care a novel and low-burden intervention to identify their risk factors and improve their physical and emotional health. It offers two nurse-led consultations to facilitate access to care for disengaged survivors. Re-engage is a synchronous, i.e. ‘live’, intervention with the option of being delivered online via WebEx – similar to Skype – or alternatively through Skype or 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 multi-disciplinary team to determine an appropriate referral pathway
3. A second online or telephone consultation with the CNC to provide medical case review feedback, referral to specialists, provide a personalised survivorship care plan, and review foreseeable barriers to adherence. This 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 two intervals subsequent to the delivery of the intervention: 1 and 6 months.
Intervention code [1] 299986 0
Behaviour
Intervention code [2] 299987 0
Lifestyle
Intervention code [3] 300186 0
Early detection / Screening
Comparator / control treatment
No control group.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 304396 0
Acceptability of the intervention. This is a composite outcome, and results will be used to assess overall acceptability. Acceptability will be assessed using:
• Length of time taken to complete the survey (minutes) and satisfaction with length (ranging 1:“too long”, to 2: “just right”, to 3:“too short”). This is measured at baseline, one month and six months post-intervention, where post-intervention is calculated from the time after the second consultation with the CNC.
• Length of time for consultations (minutes) and satisfaction with length (ranging 1:“too long”, to 2: “just right”, to 3:“too short”). This is measured at one month post-intervention, where post-intervention is calculated from the time after the second consultation with the CNC.
• Perceived benefit and burden of participation, ranging, 1: “Not at all” to 5: “Very much” and accompanied by an open-ended question. This is measured at baseline, one month and six months post-intervention, where post-intervention is calculated from the time after the second consultation with the CNC.
• Overall satisfaction with the program, including help needed and received, services needed and received, online delivery, and content (ranging 1:“Strongly disagree” to 5:“Strongly agree”). This is measured at one month post-intervention, where post-intervention is calculated from the time after the second consultation with the CNC.
• Open-ended questions regarding evaluation of the consultations and further suggestions for improvement. This is measured at one month post-intervention, where post-intervention is calculated from the time after the second consultation with the CNC.
• General satisfaction with cancer-related care, measured on a 4 point Likert scale ranging 1:“Poor” to 4:“Excellent” (with a "Not applicable" option) where participants are asked to rate follow-up care currently being received. This is measured at baseline, one month and six months post-intervention, where post-intervention is calculated from the time after the second consultation with the CNC.
Timepoint [1] 304396 0
Baseline, one month (primary timepoint) and six months post-intervention, where post-intervention is calculated from the time after the second consultation with the CNC.
Primary outcome [2] 304620 0
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 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
Timepoint [2] 304620 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] 341816 0
Self-reported health-related self-efficacy (composite outcome), assessed using a 3-item measure. This measures survivors’ belief in their sense of control over their environment and behaviour, specifically confidence in 1) asking doctors about concerns, 2) deciding when care is needed and making appointments, and 3) getting the follow-up care needed. Response options are on a Likert-type scale ranging from: (1) not confident, to (2) confident, to (3) very confident. These are summed to create a total score where a higher total score indicates greater self-efficacy.

We have also included five additional purpose designed questions to capture self-efficacy and confidence in obtaining the health care survivors require. These questions assess confidence in 1) knowledge of cancer diagnosis, 2) knowledge of treatment-related information, 3) perceived risk of late effects, 4) ability to recognise the signs of cancer recurrence or a new cancer, and 5) finding the right healthcare professionals. Response options are on a Likert-type scale ranging: (1) not confident, to (2) confident, to (3) very confident. These will be summed to create a total score where a higher total score will indicate greater self-efficacy. If the psychometric properties of this new measure (added to the original validated 3-item General Self-efficacy measure) are good, we plan to use the overall new measure of Childhood Cancer Survivorship Self-Efficacy (8 items) as the primary outcome measure.
Timepoint [1] 341816 0
Baseline, one month and six months post-intervention, where post-intervention is calculated from the time after the second consultation with the CNC.
Secondary outcome [2] 341828 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 one and six 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 [2] 341828 0
Baseline, one month and six months post-intervention, where post-intervention is calculated from the time after the second consultation with the CNC.
Secondary outcome [3] 341829 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.
Timepoint [3] 341829 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 [4] 341830 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 [4] 341830 0
Baseline, one month and six months post-intervention, where post-intervention is calculated from the time after the second consultation with the CNC.
Secondary outcome [5] 341831 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 [5] 341831 0
Baseline, one month and six months post-intervention, where post-intervention is calculated from the time after the second consultation with the CNC.
Secondary outcome [6] 341832 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 [6] 341832 0
Baseline, one month and six months post-intervention, where post-intervention is calculated from the time after the second consultation with the CNC.
Secondary outcome [7] 342369 0
Survivorship 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 risks.
Timepoint [7] 342369 0
Baseline, one month and six months post-intervention, where post-intervention is calculated from the time after the second consultation with the CNC.
Secondary outcome [8] 342582 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 [8] 342582 0
Baseline, one month and six months post-intervention, where post-intervention is calculated from the time after the second consultation with the CNC.
Secondary outcome [9] 342583 0
Health behaviours and lifestyle: pap smear screening. This question is based on previously implemented questionnaires, and selected as female childhood cancer survivors are at increased risk for HPV complications. Inclusion of this question also enables comparison with Australian normative data, collected by the Australian Bureau of Statistics.
• Pap smear screenings (ranging 1: “Never” to 5: “5 times or more”)
Timepoint [9] 342583 0
Baseline, one month and six months post-intervention, where post-intervention is calculated from the time after the second consultation with the CNC.
Secondary outcome [10] 342584 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 [10] 342584 0
Baseline, one month and six months post-intervention, where post-intervention is calculated from the time after the second consultation with the CNC.
Secondary outcome [11] 342585 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 [11] 342585 0
Baseline, one month and six months post-intervention, where post-intervention is calculated from the time after the second consultation with the CNC.
Secondary outcome [12] 342586 0
Health behaviours and lifestyle: smoking behaviours. 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.
• Smoking (ranging, 1:“Never”, to 2:“Ex-smoker”, to 3:“Current-less than 10 cigarettes per day”, to 4:“Current- more than 10 cigarettes per day”)
Timepoint [12] 342586 0
Baseline, one month and six months post-intervention, where post-intervention is calculated from the time after the second consultation with the CNC.
Secondary outcome [13] 342587 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 [13] 342587 0
Baseline, one month and six months post-intervention, where post-intervention is calculated from the time after the second consultation with the CNC.
Secondary outcome [14] 342591 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 [14] 342591 0
Baseline, one month and six months post-intervention, where post-intervention is calculated from the time after the second consultation with the CNC.
Secondary outcome [15] 342592 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 [15] 342592 0
Baseline, one month and six months post-intervention, where post-intervention is calculated from the time after the second consultation with the CNC.
Secondary outcome [16] 342593 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 [16] 342593 0
Baseline, one month and six months post-intervention, where post-intervention is calculated from the time after the second consultation with the CNC.

Eligibility
Key inclusion criteria
We will open recruitment to:
i) Survivors over 16 years.
ii) Parents of survivors under 16 years. 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.
Survivors will be eligible if they:
iii) were diagnosed with a form of cancer prior to 16 years of age
iv) were diagnosed at least 5 years prior to study participation
v) were treated for cancer at one of the participating hospitals
vi) have completed active cancer treatment
vii) are alive and in remission at the time of study participation
viii) have not received cancer-related long term follow up care in the last 2 years
iv) Or are parents of survivors less than 18 years who meet the above criteria
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
Educational / counselling / training
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
The total sample for this project was 27 participants. This was still adequately powered to achieve a medium effect size. For a pilot study, this sample is still considered sufficient for the purpose of providing initial feedback data.

Recruitment
Recruitment status
Completed
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] 9725 0
Sydney Children's Hospital - Randwick
Recruitment postcode(s) [1] 18502 0
2031 - Randwick

Funding & Sponsors
Funding source category [1] 298349 0
Charities/Societies/Foundations
Name [1] 298349 0
Cancer Council NSW
Address [1] 298349 0
153 Dowling St
Woolloomooloo
NSW, 2011
Country [1] 298349 0
Australia
Funding source category [2] 298368 0
Charities/Societies/Foundations
Name [2] 298368 0
The Kids' Cancer Project
Address [2] 298368 0
5 Mentmore Ave
Rosebery
NSW, 2018
Country [2] 298368 0
Australia
Primary sponsor type
University
Name
UNSW Sydney
Address
Barker Street
Kensington, NSW
Australia 2031
Country
Australia
Secondary sponsor category [1] 297512 0
None
Name [1] 297512 0
Address [1] 297512 0
Country [1] 297512 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 299342 0
South Eastern Sydney Local Health District, Prince of Wales Hospital Human Research Ethics Committee
Ethics committee address [1] 299342 0
Research Support Office
G71, East Wing
Edmund Blacket Building
Prince of Wales Hospital
Randwick NSW 2031
Ethics committee country [1] 299342 0
Australia
Date submitted for ethics approval [1] 299342 0
25/11/2016
Approval date [1] 299342 0
23/01/2017
Ethics approval number [1] 299342 0
LNR/16/POWH/695

Summary
Brief summary
The purpose of this research is to assess the acceptability and feasibility of a nurse-led distance-delivered intervention for childhood cancer survivors who have become disengaged with their cancer follow-up.

Who is it for?
You may be eligible for this study if you are a childhood cancer survivor over the age of 16 or are parents of a childhood cancer survivor currently under the age of 18.

Study details:
Each participant will be provided with two nurse-led consultations aiming to facilitate access to care for survivors of childhood cancer who have not been followed up in the last 2 years. These consultations will be offered to the participant via WebEx – similar to Skype - or on the phone (as chosen by the participant). After the first consultation with the nurse, the participant’s medical case will be reviewed by a multi-disciplinary team to determine the appropriate route of care.

All participants will be invited to complete a questionnaire prior to the intervention and questionnaires at two intervals subsequent to the delivery of the intervention: 1 and 6 months. This study will help to determine the acceptability of the consultations to participants, and we hope will also offer survivors whom currently have no access to healthcare, a new and low-burden way to improve their health.
Trial website
https://www.behaviouralsciencesunit.org/re-engage.html
Trial related presentations / publications
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.
Public notes
Attachments [1] 2328 2328 0 0

Contacts
Principal investigator
Name 80122 0
Prof Claire Wakefield
Address 80122 0
Kids Cancer Centre
Level 1 South, Sydney Children's Hospital
High Street
Randwick
NSW, 2031
Country 80122 0
Australia
Phone 80122 0
(+612) 9382 3113
Fax 80122 0
Email 80122 0
c.wakefield@unsw.edu.au
Contact person for public queries
Name 80123 0
Ms Christina Signorelli
Address 80123 0
Kids Cancer Centre
Level 1 South, Sydney Children's Hospital
High Street
Randwick
NSW, 2031
Country 80123 0
Australia
Phone 80123 0
(+612) 9382 5563
Fax 80123 0
Email 80123 0
c.signorelli@unsw.edu.au
Contact person for scientific queries
Name 80124 0
Ms Christina Signorelli
Address 80124 0
Kids Cancer Centre
Level 1 South, Sydney Children's Hospital
High Street
Randwick
NSW, 2031
Country 80124 0
Australia
Phone 80124 0
(+612) 9382 5563
Fax 80124 0
Email 80124 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
Have study results been published in a peer-reviewed journal?
No
Other publications
Have study results been made publicly available in another format?
No
Results – basic reporting
Results – plain English summary