Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000857707
Ethics application status
Approved
Date submitted
1/06/2022
Date registered
17/06/2022
Date last updated
5/07/2024
Date data sharing statement initially provided
17/06/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Overcoming language barriers with the use of an instant translation device for culturally and linguistically diverse patients receiving radiation therapy
Scientific title
A prospective stage 3 study recruiting 50 Mandarin speaking cancer patients undergoing radiotherapy to evaluate patient satisfaction and experience of verbal communication with the use of an instant translation device (IITD)
Secondary ID [1] 307257 0
nil
Universal Trial Number (UTN)
Trial acronym
ORBIT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cancer requiring radiotherapy treatment 326513 0
Condition category
Condition code
Cancer 323777 323777 0 0
Any cancer
Public Health 323866 323866 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
An instant translation device (ITD) will be utilised by consenting Mandarin speaking patients when they present for daily radiotherapy treatment.
At present there is an expanding market for ITDs spanning the Logbar Ili, Google Pixel Buds, The Pilot and Travis the Translator to name a few. Whilst many current ITDs are limited to one-way communication, WiFi reliance, or in-ear insertion, Travis the Translator provides a robust and appropriate design for use in a clinical environment. The first prototype of Travis the Translator (Travis One) was completed in February 2017, and shipped from September 2017. To date, the Rotterdam-based group have in excess of 50,000 users across 100 countries. Travis the Translator offers one-touch ease of use, interpreting up to 80 languages online and 23 languages offline within two seconds of acquisition.
The ITD will not replace the use of the interpreter at Computer Tomography (CT) simulation, fraction 1, or subsequent nursing/Radiation Oncology (RO)/Allied Health (AH)consultations, but rather facilitate all other daily radiation therapy interactions between Radiation Therapists (RT) and patient, including before and during patient positioning and after radiotherapy session completed.
The ITDs are physical devices and are supplied by Peter MacCallum Cancer Centre to Liverpool and Macarthur Cancer Therapy Centres. Radiotherapy staff will be trained to operate ITD for participants, and will be in charge of maintaining and storing device. ITDs are not accessible by participants.
Participants will be utilising ITD for daily radiotherapy set up and discussions, this is dependent on the number of fractions prescribed by the RO and will differ between individual participants depending on their treatment schedule. Participants receiving less than 5 days of treatment are excluded from trial. A log sheet will be kept to detail the amount of times ITD is used.
Participants use the device by speaking Mandarin into the device, which has an inbuilt microphone and is operated by staff, and the device will translate to English via an inbuilt speaker. Staff will use the device by speaking English into the device for it to be translated into Mandarin. There is no use of headphones.

Treatment Fraction 1: Participant to undergo standard Radiation Therapy information session with interpreter. Participant to be provided with ITD training and familiarisation. Daily log sheet to be completed by RTs

Subsequent Treatment Fractions: Participant to utilise ITD for daily setup, and discussion with RT staff. Daily log sheet to be completed by RTs.

Final Treatment Fraction: Participant to complete a satisfaction and experience survey as assisted by an interpreter present at the final nursing review. Trial coordinator to liaise with site lead to complete the end of treatment summary
When a patient withdraws from the study, the reasons for withdrawal shall be recorded by the investigator on the relevant page of the log sheet. Whenever possible, all patients who withdraw from the study prematurely will confirm permission to retain the data provided thus far. Patients who fail to return for radiation treatment will be followed up by the treating radiation therapists as part of standard care.
Intervention code [1] 323696 0
Behaviour
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 331534 0
Report the patient satisfaction and experience of ITD use in the context of radiation therapy delivery with Mandarin-speaking patients across the Victorian and New South Wales public health service.
Satisfaction and experience to be considered as a composite outcome. Outcome is assessed using a paper based patient survey. The name of the questionnaire is Orbit Stage 3 Case Report Form: Patient Satisfaction & Experience Survey
Timepoint [1] 331534 0
After patient treatment completion
Secondary outcome [1] 410209 0
Average appointment duration of patient radiotherapy set up. Measured by recording radiotherapy appointment times. This is measured using the patient information record system which records automatically the start and stop time of each treatment session for each participant.
Timepoint [1] 410209 0
After each patients treatment completion

Eligibility
Key inclusion criteria
The patient is 18 years of age or older.
The patient is diagnosed with cancer and has been referred for radiation therapy.
The patient is planned to receive radiation therapy for a period of 5 days or more.
The patient self-reports Mandarin as the primary language spoken at home.
The patient self-reports a basic level of Mandarin literacy.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
The patient has not previously received radiation therapy.
The patient has no known functional or cognitive impairment that would limit their ability to utilise the device and or formulate a response.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Data collected is being analysed
Reason for early stopping/withdrawal
Participant recruitment difficulties
Date of first participant enrolment
Anticipated
30/06/2022
Actual
20/12/2022
Date of last participant enrolment
Anticipated
Actual
29/08/2023
Date of last data collection
Anticipated
Actual
12/10/2023
Sample size
Target
50
Accrual to date
Final
4
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 24799 0
Peter MacCallum Cancer Centre - Melbourne
Recruitment hospital [2] 24800 0
Austin Health - Austin Hospital - Heidelberg
Recruitment hospital [3] 24801 0
Liverpool Hospital - Liverpool
Recruitment hospital [4] 24802 0
Campbelltown Hospital - Campbelltown
Recruitment postcode(s) [1] 40442 0
3000 - Melbourne
Recruitment postcode(s) [2] 40443 0
3084 - Heidelberg
Recruitment postcode(s) [3] 40444 0
2170 - Liverpool
Recruitment postcode(s) [4] 40445 0
2560 - Campbelltown

Funding & Sponsors
Funding source category [1] 311554 0
Self funded/Unfunded
Name [1] 311554 0
nil
Country [1] 311554 0
Primary sponsor type
University
Name
Monash University Graduate Research Office
Address
Chancellery Building D, 26 Sports Walk
Monash University, Clayton
Victoria 3800
Country
Australia
Secondary sponsor category [1] 312984 0
None
Name [1] 312984 0
Address [1] 312984 0
Country [1] 312984 0
Secondary sponsor category [2] 315798 0
Hospital
Name [2] 315798 0
Peter MacCallum Cancer Centre
Address [2] 315798 0
305 Grattan Street
Melbourne VIC 3000
Country [2] 315798 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 311004 0
Peter MacCallum Cancer Centre Human Research Ethics Committee
Ethics committee address [1] 311004 0
Ethics committee country [1] 311004 0
Australia
Date submitted for ethics approval [1] 311004 0
Approval date [1] 311004 0
16/05/2022
Ethics approval number [1] 311004 0

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

Contacts
Principal investigator
Name 119662 0
Miss Alicia Haman
Address 119662 0
Ingham Institute, 1 Campbell St, Liverpool NSW 2170
Country 119662 0
Australia
Phone 119662 0
+61 2 87389155
Fax 119662 0
Email 119662 0
alicia.haman@health.nsw.gov.au
Contact person for public queries
Name 119663 0
Penny Phan
Address 119663 0
Ingham Institute, 1 Campbell St, Liverpool NSW 2170
Country 119663 0
Australia
Phone 119663 0
+61 2 87389148
Fax 119663 0
Email 119663 0
SWSLHD-RadOncClinicalTrials@health.nsw.gov.au
Contact person for scientific queries
Name 119664 0
Penny Phan
Address 119664 0
Ingham Institute, 1 Campbell St, Liverpool NSW 2170
Country 119664 0
Australia
Phone 119664 0
+61 87389148
Fax 119664 0
Email 119664 0
SWSLHD-RadOncClinicalTrials@health.nsw.gov.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Data will be collected and analysed as a whole to provide trends and outcomes.
Non-identifiable data will be shared between participating sites and lead coordinating site for analysis.
Outcomes of study may potentially be shared for future relevant studies to improve recruitment for non-English speaking patients. However raw line-by-line data will not be shared publicly


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.