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Trial registered on ANZCTR


Registration number
ACTRN12614001142628
Ethics application status
Approved
Date submitted
12/09/2014
Date registered
29/10/2014
Date last updated
14/09/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Is Telehealth an effective means of implementing psychosocial support to adolescents and young adults (AYA’s) with cancer?
Scientific title
Do Adolescents and Young Adults (AYAs) with cancer receive more cost effective, feasible and acceptable psychosocial care and evaluation by telehealth or in person?
Secondary ID [1] 284875 0
Nil
Universal Trial Number (UTN)
U1111-1158-5447
Trial acronym
AYA Telehealth Study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cancer 292310 0
Psychosocial wellbeing in AYA population 292311 0
Condition category
Condition code
Cancer 292646 292646 0 0
Any cancer
Mental Health 292647 292647 0 0
Depression
Mental Health 292648 292648 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Receiving psychosocial care and evaluation by telehealth by a psychologist/social worker. The assessment will be administered via telehealth using a WebEx interface across the internet. Questionnaires will also assist in the evaluation and care processes. Communication for appointments may be via letter, email, text messaging, or phone. Semi-structured clinical interview based on the validated Home & Environment Education, Employment Eating Exercise Activities and Drugs Sexual activity Sexuality and Suicide/Mental Risk (HEADSS) assessment. The assessment involves discussing a range of important aspects relating to the young persons psychosocial and mental health issues, family, peers, relationship, school and other concerns. This may involve incidental supportive counselling and may involve incidental support through cognitive behavioural coping strategies. however the primary intervention is the structural interview process. The assessment is intended to take approximately 15-20 minutes for completion of questionnaires and about 5 minutes after the interview assessment. The assessment with the psychologist will take approximately 1 hour.
The evaluation and care will be assessing satisfaction of care, perceptions of care providers, anxiety and depression aspects.
The psychosocial assessments will be administered at baseline, 6 months, 12 months and 24 month timepoints.
Intervention code [1] 289683 0
Treatment: Other
Comparator / control treatment
Receiving psychosocial care and evaluation in-person by a psychologist/social worker. The evaluation and care will be assessing satisfaction of care, perceptions of care providers, anxiety and depression aspects.Semi-structured clinical interview based on the validated HEADSS assessment. The assessment involves discussing a range of important aspects relating to the young persons psychosocial and mental health issues, family, peers, relationship, school and other concerns. This may involve incidental supportive counselling and may involve incidental support through cognitive behavioural coping strategies. however the primary intervention is the structural interview process. The assessment is intended to take approximately 15-20 minutes for completion of questionnaires and about 5 minutes after the interview assessment. The assessment with the psychologist will take approximately 1 hour.
The psychosocial assessments will be administered at baseline, 6 months, 12 months and 24 month timepoints.
Control group
Active

Outcomes
Primary outcome [1] 292484 0
1. Acceptability of the assessment
Measured using:
*Youth Satisfaction Questionnaire (YSQ)17,18: 5 items assessing satisfaction with care and overall experience, followed by several ratings of specific aspects of psychosocial assessment process.
*Acceptability questions about online assessment/intervention relative to a hypothetical in-person version (or vice versa) by participant and by staff
*The Working Alliance Inventory (Horvath & Greenberg 1983) : 12 items assessing the young person’s perceptions of their relationship (rapport and understanding) with the AYA clinical psychologist/social worker who conducted their assessment. This questionnaire has been modified to use Australian terminology.
*Treatment Credibility and expectations questionnaire (modified for the purposes of this study).
Timepoint [1] 292484 0
These measures are completed by each study participant at 4 time points in total throughout the study (at study entry, 6 months, 12 months and 24 months). The data will be viewed once 40 patients have completed treatment, once 80 patients have completed treatment and finally once all study participants have completed treatment.
Primary outcome [2] 292485 0
2. Feasibility
*Protocol adherence to ‘gold-standard’ processes (e.g., frequency of multi-disciplinary teams (MDTs) where all the necessary people are there, proportion of times that a GP chooses to be ‘linked in’ to the process, etc)
*Technical difficulties and logistical aspects of delivering/receiving intervention including Kilometers from YCS to home in kilometers (using Google maps) and total time taken to travel to appointment, including travel and parking time as well as any out of pocket expenses (eg parking, petrol). One direction only.
*% appointments conducted within a reasonable timeframe, timeliness of assessment administration
Timepoint [2] 292485 0
These measures are completed by each study participant at 4 time points in total throughout the study (at study entry, 6 months, 12 months and 24 months). The data will be viewed once 40 patients have completed treatment, once 80 patients have completed treatment and finally once all study participants have completed treatment.
Primary outcome [3] 292486 0
3. Distress and Quality of Life during study period
*AYA Oncology Screening Tool
*Kessler10 (assesses anxiety and depression symptoms in the past 4 weeks). There are 10 items widely used with Australian AYAs and recommended as the Australian Federal Government mental health measure.
*AYA cancer-specific quality of life: Peds-QL-AYA (Ewings etc 2009)
Timepoint [3] 292486 0
These measures are completed by each study participant at 4 time points in total throughout the study (at study entry, 6 months, 12 months and 24 months). The data will be viewed once 40 patients have completed treatment, once 80 patients have completed treatment and finally once all study participants have completed treatment.
Secondary outcome [1] 309089 0
4. Cost-effectiveness / cost-utility: Eight items will be devised in consultation with the Cancer Research Economics Support Team (CREST), an initiative of Cancer Australia.
*Also, comparison of the cost of delivering psychosocial service in-person or by teleconference will be made. Savings for patients and their families in terms of distance, time and expense per visit will be collected for all the patients.
1. How the participant heard about the service
2. Demographics
3. Understanding of telemedicine and how they feel about having support using this method, as well as preferred method of support at baseline in an ‘ideal-world’ situation
4. Whether the patient has ever seen a AYA clinical psychologist/social worker or counselor before
5. Tumour type and stage (validated Treatment Intensity Scale)
6. Intended treatment intent (curative or palliative)
7. % patients who decline the allocated arm and choose to participate on the other treatment arm, % attrition
8. Reliability checks regarding therapist adherence
Timepoint [1] 309089 0
These measures are completed by each study participant at 4 time points in total throughout the study (at study entry, 6 months, 12 months and 24 months). The data will be viewed once 40 patients have completed treatment, once 80 patients have completed treatment and finally once all study participants have completed treatment.

Eligibility
Key inclusion criteria
1. AYA cancer patients aged between 15 years and 25 years.
2. Patients who have been newly diagnosed or who have relapsed with a malignant haematological or oncological diagnosis
3. Patients who will undergo curative or palliative therapy which may include chemotherapy, surgery and radiotherapy in different combinations.
4. AYA patient being treated at any paediatric or adult cancer centre in NSW and ACT
5. Patient who are mentally/physically able to participate in either in-person psychosocial assessment or teleconference consultations.
6. Patients who speak limited English can be enrolled as long as the sessions are undertaken with an interpreter present at the telehealth site or in-person at consultation. The participant must be able to complete the questionnaires (which are in English).
Minimum age
15 Years
Maximum age
25 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Patients with a disability that does not permit the completion of questionnaires or an inability to participate in the study, as determined by the health professional or the carer.
2. Patients unable to participate in the psychosocial consults or completion of the questionnaires for the duration of the study (for language or other reason).

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Patients are approached by the study coordinator/treating doctor/psychologist/social worker to consider the study. Once voluntary, informed consent is obtained, an independent person outside the Oncology Department is contacted to reveal the allocation for the patient.
The doctor/study coordinator who enrolled the patient will not be involved in patient allocation. Allocation is concealed using sealed opaque envelopes prepared by an independent statistician. The envelopes will be kept in another department.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The independent statistician will use a Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation).
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety
Statistical methods / analysis
The sample size has been predetermined to be 130 participants. Assuming a standard deviation of the anxiety measure (AYA Oncology Screening Tool) from questionnaires to be 4.7, power of 80%, and 5% confidence interval, the minimum effective size difference between the two treatments is estimated to be 2.31 units. This means, that if there is a difference between telehealth and in-person treatments, it will be deemed to be significant if that difference is over 2.31 units with other factors remaining constant.
Patients who consent to participation will be allocated a randomised treatment based on a pre-determined randomised list that has been generated by an independent statistician. Patients who decline their allocated randomisation will be excluded and their allocation will be allocated to the next consenting study participant. Patients who want to move treatment arm will also be excluded. However data from excluded patients who completed the study will be used in the study analyses.
Randomised patients will be analysed according to the treatment they received. Interim results will be reviewed when 40 patients and 80 patients have been recruited and again when 120 patients have been recruited. The outcome measures will be analysed at start to examine baseline profiles, then at 6 months and annually. Data will be adjusted for fixed factors and analysed using multifactor models to test significant differences between telehealth and in-person evaluation methods. Other factors influencing the trial will be also examined.

Recruitment
Recruitment status
Stopped early
Data analysis
Data analysis is complete
Reason for early stopping/withdrawal
Lack of funding/staff/facilities
Participant recruitment difficulties
Other reasons/comments
Other reasons
Accreditation of child psychologist at Adult Hospital hindered recruitment activities
Date of first participant enrolment
Anticipated
3/11/2014
Actual
24/11/2015
Date of last participant enrolment
Anticipated
3/10/2016
Actual
3/10/2016
Date of last data collection
Anticipated
Actual
27/10/2016
Sample size
Target
130
Accrual to date
Final
19
Recruitment in Australia
Recruitment state(s)
ACT,NSW
Recruitment postcode(s) [1] 8359 0
2031 - Randwick
Recruitment postcode(s) [2] 8358 0
2145 - Westmead
Recruitment postcode(s) [3] 8673 0
2298 - Waratah
Recruitment postcode(s) [4] 8361 0
2305 - New Lambton
Recruitment postcode(s) [5] 8362 0
2606 - Phillip

Funding & Sponsors
Funding source category [1] 289495 0
Charities/Societies/Foundations
Name [1] 289495 0
Kids Cancer Alliance
Country [1] 289495 0
Australia
Primary sponsor type
Hospital
Name
The Sydney Childrens Hospitals Network
Address
Locked Bag 4001
Westmead NSW 2145
Country
Australia
Secondary sponsor category [1] 288178 0
None
Name [1] 288178 0
Address [1] 288178 0
Country [1] 288178 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291248 0
The Sydney Children's Hospitals Human research ethics committee
Ethics committee address [1] 291248 0
Locked Bag 4001
Westmead
2145 NSW
Ethics committee country [1] 291248 0
Australia
Date submitted for ethics approval [1] 291248 0
07/09/2014
Approval date [1] 291248 0
14/10/2014
Ethics approval number [1] 291248 0
Ethics committee name [2] 298610 0
ACT Health HREC
Ethics committee address [2] 298610 0
Research Ethics and Governance
Health Directorate, ACT Government
Canberra Hospital, Yamba Drive, Garran ACT 2605
Ethics committee country [2] 298610 0
Australia
Date submitted for ethics approval [2] 298610 0
10/12/2014
Approval date [2] 298610 0
17/07/2015
Ethics approval number [2] 298610 0
ETH.1.15.001

Summary
Brief summary
The aim of this study is to determine whether telehealth is more cost effective, feasible and acceptable than in person psychological support for adolescents and young adults (AYAs) with cancer.

Who is it for? You may be eligible to join this study if you are aged between 15 years and 25 years and have been newly diagnosed or have relapsed with cancer, for which you will undergo curative or palliative therapy at any paediatric or adult cancer centre in NSW or ACT.

Study details Participants in this study will be randomly (by chance) allocated to one of two groups. Participants in one group will receive psychological support via telehealth, whilst participants in the other group will receive in person psychological support. The psychosocial evaluation will be carried out at baseline, 6 months, 12 months and 24 months. All participants will be asked to complete a number of questionnaires at these time points relating to treatment acceptability and satisfaction, anxiety and quality of life. This will enable us to work out how effective telehealth is in implementing psychosocial support among AYAs with cancer, while also assessing its use as an age-appropriate model of delivering support, taking into account developmental concerns around autonomy and independence. An additional aim is to demonstrate evidence supporting the validity of the AYA Psychosocial Assessment Screening Tool and Psychosocial Assessment. While the distress thermometer (DT) is widely used and has been validated in numerous adult cancer populations, participants under the age of 18 have been excluded. Thus, there isn’t currently a validated instrument for measuring distress amongst AYAs with cancer.
Trial website
NA
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 49494 0
Dr Antoinette Anazodo
Address 49494 0
Medical Professorial Unit
Sydney Children's Hospital
1st floor, South wing, Edmund Blackett Building
High St
Randwick 2031
NSW
Country 49494 0
Australia
Phone 49494 0
+612 9382 1733
Fax 49494 0
Email 49494 0
antoinette.anazodo@sesiahs.health.nsw.gov.au
Contact person for public queries
Name 49495 0
Ursula Sanson-Daly
Address 49495 0
Kids Cancer Centre
Sydney Children's Hospital
High St/Barker St
Randwick
NSW 2031
Country 49495 0
Australia
Phone 49495 0
+61481 554 493
Fax 49495 0
Email 49495 0
Ursula.Sansom-daly@SESIAHS.HEALTH.NSW.GOV.AU
Contact person for scientific queries
Name 49496 0
Antoinette Anazodo
Address 49496 0
Medical professional unit
Sydney Children's Hospital
1st floor, South wing, Edmund Blackett Building
High St
Randwick 2031
NSW
Country 49496 0
Australia
Phone 49496 0
+612 9382 1733
Fax 49496 0
Email 49496 0
antoinette.anazodo@sesiahs.health.nsw.gov.au

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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