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Trial registered on ANZCTR


Registration number
ACTRN12611000052932
Ethics application status
Approved
Date submitted
10/01/2011
Date registered
14/01/2011
Date last updated
30/05/2011
Type of registration
Prospectively registered

Titles & IDs
Public title
Assessing speech and language in children with cancer: An RCT comparing in-person assessment with assessment via telehealth.
Scientific title
In children with cancer, is speech and language assessment via telehealth comparable to traditional in-person assessment for cost; visual and audio quality; and patient, caregiver and therapist satisfaction?
Secondary ID [1] 253376 0
N/A
Universal Trial Number (UTN)
U1111-1118-9613
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
children's cancer 260925 0
speech and language disorder 260929 0
Condition category
Condition code
Cancer 259058 259058 0 0
Children's - Other
Mental Health 259060 259060 0 0
Learning disabilities

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A brief speech and language screening assessment (including a receptive language task, an expressive language task, and a speech task) will be administered to the subjects under 2 telehealth conditions:
a) via real-time video videoconferencing - with visual and audio information transmitted over videoconferencing, and with printed information (e.g., assessment stimulus items) being transmitted from the therapist's computer to the child’s computer using remote access software.
b) via internet-based real-time video – with visual information transmitted over the internet, audio information transmitted over speaker phone, and printed information (e.g., assessment stimulus items) being transmitted from the therapist’s computer to the child’s computer using remote access software.
The children will also complete the screening assessment in-person (comparator condition). The order of these 3 conditions will be random.

Each screening assessment will take approximately 15 minutes, and the child will be assessed under all both telehealth conditions and also the in-person condition (comparator) on one day. All conditions will be simulated at the Royal Children's Hospital (for the videoconferencing and internet-based conditions the therapist will be located in another part of the hospital). The parent or caregiver will be present in the room with the child during all conditions. Similar but different receptive and expressive language screening tasks will be administered in each condition to avoid the test-retest effect. As each assessment is very short (15 minutes duration), there will be no “wash-out” period and the children will be assessed in each of the 2 telehealth conditions and also the comparator condition (in-person) consecutively.

Children will be divided up into two groups: the preschool-aged group (3 – 5 years) and the school-aged group (6 – 12 years).
The screening assessment for the preschool-aged group will consist of:
a) The Diagnostic Screener and Oromotor Assessment subtests from the Diagnostic Evaluation of Articulation and Phonology (DEAP) (Pearson Clinical Assessment). This will be administered in both telehealth conditions and also the in-person (comparator) condition.
b) The Preschool Language Scale – 4th Edition Screening Test (PLS-4 Screener) (Pearson Clinical Assessment). This will be administered in 1 condition only (random selection - may be administered in either of the telehealth conditions or the in-person (comparator) condition).
c) Selected items from the Preschool Language Scale – 4th Edition (PLS-4) (Pearson Clinical Assessment). Selected items will be chosen to mirror similar items in the screening test. Two different sets of items will be administered in the other two conditions (random selection).

The screening assessment for the 6 – 12 years age group will consist of:
a) The Diagnostic Screener and Oromotor Assessment subtests from the Diagnostic Evaluation of Articulation and Phonology (DEAP) (Pearson Clinical Assessment). This will be administered in both telehealth conditions and also the in-person (comparator) condition.
b) The Clinical Evaluation of Language Fundamentals – 4th Edition Screening Test (CELF-4 Screener) (Pearson Clinical Assessment). This will be administered in 1 condition only (random selection - may be administered in either of the telehealth conditions or the in-person (comparator) condition).
c) Selected items from the Clinical Evaluation of Language Fundamentals – 4th Edition (CELF-4) (Pearson Clinical Assessment). Selected items will be chosen to mirror similar items in the screening test. Two different sets of items will be administered in the other two conditions (random selection).

Following assessment under all 3 conditions the child will return on another day (within one month of the first day) for a comprehensive speech and language assessment. This will be administered in-person.
The comprehensive assessment for the preschool-aged group will consist of:
a) The Articulation and Phonology subtests from the Diagnostic Evaluation of Articulation and Phonology (DEAP) (Pearson Clinical Assessment).
b) The Clinical Evaluation of Language Fundamentals Preschool – 2nd Edition (CELF-P2) (Pearson Clinical Assessment).

The comprehensive assessment for the school-aged group will consist of:
a) The Articulation and Phonology subtests from the Diagnostic Evaluation of Articulation and Phonology (DEAP) (Pearson Clinical Assessment).
b) The Comprehensive Assessment of Spoken Language (CASL) (Pearson Clinical Assessment).
Intervention code [1] 257822 0
Diagnosis / Prognosis
Comparator / control treatment
The comparator is the traditional in-person speech and language screening condition. The speech and language screening assessment will also be administered in this condition (assessment items described above in “descriptions of intervention/exposure”). This screening assessment will take approximately 15 minutes. The order of conditions will be randomly selected.
Control group
Active

Outcomes
Primary outcome [1] 259916 0
Quality of audio and visual information.

Measured by:
a) number of times the patient or caregiver requests a repetition during assessment
b) number of times the clinician requests repetition from the patient or caregiver
c) number of breaks in audio signal
d) number of breaks in visual signal
e) total time to complete assessment.
Timepoint [1] 259916 0
During administration of assessment via telehealth and in-person.
Primary outcome [2] 259917 0
Cost.

Measured by: a cost and feasibility analysis will be performed based on the participant accessing the assessment service via telehealth from their residential address or local hospital, or in-person at a tertiary centre, including accommodation and travel costs from their residential address.
Timepoint [2] 259917 0
Immediately following assessment via telehealth and in-person.
Primary outcome [3] 259918 0
Patient, caregiver and therapist satisfaction.

Measured by: a survey will be developed specifically for use in this study. Patients, caregivers and therapists will be asked to complete the survey after each condition, and then after all 3 conditions have been administered they will be asked to rate their preference. The children will be asked to rate different aspects of the assessment as either ?good? ?ok? or ?bad?. The caregivers and therapists will be asked to rate different aspects of the assessment out of a 5 point scale, with 1 = strongly disagree, and 5 = strongly agree.
Timepoint [3] 259918 0
Immediately following assessment.
Secondary outcome [1] 268813 0
Nil
Timepoint [1] 268813 0
Nil

Eligibility
Key inclusion criteria
Children with cancer who are already seen by a speech pathologist at the Royal Children's Hospital, Brisbane.
Minimum age
3 Years
Maximum age
12 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
a) Participants whose first language is other than English.
b) Participants who are palliative or acutely unwell at the time of the study.
c) Participants who are not suitable for standardised speech and language assessment (e.g., children with severely delayed language, severe attention deficits).

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation by pulling order of sequence out of a hat for each participant.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Nil
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
15/06/2011
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 258296 0
Government body
Name [1] 258296 0
Queensland Health
Country [1] 258296 0
Australia
Primary sponsor type
Individual
Name
Ms Olivia Taylor
Address
Speech Pathology Department
Level 4 Coles Building
Royal Children's Hospital,
Herston Road,
Herston, QLD, 4029
Country
Australia
Secondary sponsor category [1] 257459 0
Individual
Name [1] 257459 0
Dr Pamela Dodrill
Address [1] 257459 0
Speech Pathology Department
Level 4 Coles Building
Royal Children's Hospital
Herston Road,
Herston, QLD, 4029
Country [1] 257459 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 260281 0
QLD Children's Health Services (RCH) Human Research Ethics Committee
Ethics committee address [1] 260281 0
Ethics committee country [1] 260281 0
Australia
Date submitted for ethics approval [1] 260281 0
14/02/2011
Approval date [1] 260281 0
11/04/2011
Ethics approval number [1] 260281 0
HREC/11/QRCH/26
Ethics committee name [2] 269146 0
Behavioural & Social Sciences Ethical Review Committee, University of Queensland.
Ethics committee address [2] 269146 0
Ethics committee country [2] 269146 0
Australia
Date submitted for ethics approval [2] 269146 0
19/04/2011
Approval date [2] 269146 0
28/04/2011
Ethics approval number [2] 269146 0
2011000492

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

Contacts
Principal investigator
Name 32072 0
Address 32072 0
Country 32072 0
Phone 32072 0
Fax 32072 0
Email 32072 0
Contact person for public queries
Name 15319 0
Ms Olivia Taylor
Address 15319 0
Speech Pathology Department
Level 4 Coles Building
Royal Children's Hospital
Herston Road,
Herston, QLD, 4029
Country 15319 0
Australia
Phone 15319 0
+617 3636 8508
Fax 15319 0
+617 3636 1978
Email 15319 0
Olivia_Taylor@health.qld.gov.au
Contact person for scientific queries
Name 6247 0
Ms Olivia Taylor
Address 6247 0
Speech Pathology Department
Level 4 Coles Building
Royal Children's Hospital
Herston Road,
Herston, QLD, 4029
Country 6247 0
Australia
Phone 6247 0
+617 3636 8508
Fax 6247 0
+617 3636 1978
Email 6247 0
Olivia_Taylor@health.qld.gov.au

No information has been provided regarding IPD availability


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No Supporting Document Provided



Results publications and other study-related documents

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