Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000789763
Ethics application status
Approved
Date submitted
19/04/2022
Date registered
3/06/2022
Date last updated
13/06/2024
Date data sharing statement initially provided
3/06/2022
Type of registration
Retrospectively registered

Titles & IDs
Public title
Culturally and Linguistically Diverse cancer patient recruitment to MRI Radiotherapy Clinical Trials
Scientific title
Evaluating the feasibility and outcomes of using translated educational materials to increase Culturally and Linguistically Diverse cancer patient recruitment to MRI Radiotherapy Clinical Trials
Secondary ID [1] 306958 0
None
Universal Trial Number (UTN)
Trial acronym
CALD
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cancer 326072 0
Condition category
Condition code
Cancer 323383 323383 0 0
Any cancer

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Chinese, Vietnamese and Arabic speaking patients will be given MRI educational brochures translated in their language to read in their own time. Content covered includes what an MRI and radiation therapy is, what takes place during MRI, and background on MRI clinical trials. ePosters and physical posters in the respective languages are also displayed around clinic rooms and waiting areas with brief information on the benefits of MRI clinical trials.

The main intervention is a 5 minute animated educational video with audio and captions in Arabic and Vietnamese. This video explains the benefits of clinical trial participation and provides general education on MRI safety and its role in radiation therapy. The video will be embedded in a Qualtrics survey which asks patients their opinions on MRI in radiotherapy before and after video viewing. Patients will complete the survey and video viewing in one sitting with a member of the research team present. MRI Brochures will be given to the patient in person to read in their own time, as they cover the same information as the video.

All materials were devised by the research team and/or commissioned specifically this study. However, upon study completion these materials may be further refined and distributed to other patients as part of standard educational material in our clinics.
There is no difference in involvement for patients in each arm, these are allocated based on
Arm A is allocated to patients eligible for MRI trials in the department (patients can ask staff for more details).
Arm B is for patients who require MRI for radiotherapy treatment planning, but are ineligible for MRI trials.
Arm C is for patients who do not meet the above criteria (i.e. not having MRI as part of their treatment), but are still having CT simulation for their treatment planning.
Intervention code [1] 323695 0
Behaviour
Comparator / control treatment
No Control Group, arms are allocated to differentiate which patient cohorts have been given the study mtaerial
Control group
Uncontrolled

Outcomes
Primary outcome [1] 331122 0
Willingness from Culturally and Linguistically Diverse (CALD) populations to participate in clinical trials for radiotherapy as reported in survey responses pre and post video viewing. Responses are assessed using a 5-point Likert scale, and participants can indicate reasons why they are or are not willing to participate in an MRI radiotherapy clinical trial.
Timepoint [1] 331122 0
Arm A - post MRI Simulation (MRI Sim)
Arm B - post MRI Sim
Arm C - during end of treatment visit with clinician, or during post-treatment follow up
Secondary outcome [1] 408843 0
Number of Culturally and Linguistically Diverse (CALD) patients recruited to clinical trials of MRI in radiotherapy by audit of clinical trial enrolment records and demographic data.
Timepoint [1] 408843 0
Arm A - post MRI Sim after survey completion
Arm B - post MRI Sim after survey completion
Arm C - during end of treatment visit with clinician, or during post-treatment follow up after survey completion

Eligibility
Key inclusion criteria
Inclusion Criteria for Arms A, B and C includes:
1. Chinese, Arabic and Vietnamese CALD patients that require interpretive services.
2. Attending Liverpool, Campbelltown or Bankstown Cancer Therapy Centre Clinics for Radiation Oncology Consultation.

Inclusion Criteria for Arm A only:
- Eligible for any currently recruiting MRI trials within the department (listed on internal department SharePoint site).

Inclusion Criteria for Arm B only:
- Requires MRI for radiotherapy Treatment planning.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Mentally impaired participants or participants for whom attaining informed consent would be difficult
2. Patients fluent in English and/or do not require Arabic or Vietnamese Interpreters
3. Patient refusal
4. Age <18 years
5. Pregnancy
6.Contraindications to MRI

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The sample size is based off retrospective Mosaiq (oncology information system) data captured from Dec 2018 to Dec 2019 where 576 patients of Chinese, Arabic and Vietnamese background requiring interpreter bookings for their radiation oncology consultation. The study will be open for 12 months therefore we anticipate a sample size of 100 patients.

Statistical analysis will include student T tests to measure the significance of any differences in:
- Pre and post educational intervention recruitment rates of CALD patients to MRI radiotherapy trials.
- Pre and post survey responses indicating willingness to participate in MRI radiotherapy clinical trials.

Observational data will be used as a qualitative feedback tool to measure participant compliance and highlight if any adjustments to the educational brochure may be required, when determining feasibility of recruiting CALD patients to MRI radiotherapy clinical trials.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
11/05/2022
Date of last participant enrolment
Anticipated
9/11/2024
Actual
Date of last data collection
Anticipated
30/11/2024
Actual
Sample size
Target
100
Accrual to date
89
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 22469 0
Liverpool Hospital - Liverpool
Recruitment hospital [2] 22470 0
Campbelltown Hospital - Campbelltown
Recruitment hospital [3] 22471 0
Bankstown-Lidcombe Hospital - Bankstown
Recruitment postcode(s) [1] 37703 0
2170 - Liverpool
Recruitment postcode(s) [2] 37704 0
2560 - Campbelltown
Recruitment postcode(s) [3] 37705 0
2200 - Bankstown

Funding & Sponsors
Funding source category [1] 311276 0
University
Name [1] 311276 0
University Of New South Wales
Country [1] 311276 0
Australia
Primary sponsor type
University
Name
University Of New South Wales
Address
UNSW Sydney
High St
Kensington, NSW 2052
Australia
Country
Australia
Secondary sponsor category [1] 312635 0
None
Name [1] 312635 0
Address [1] 312635 0
Country [1] 312635 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310782 0
South Western Sydney Local Health District
Ethics committee address [1] 310782 0
Ethics committee country [1] 310782 0
Australia
Date submitted for ethics approval [1] 310782 0
28/09/2020
Approval date [1] 310782 0
09/11/2020
Ethics approval number [1] 310782 0

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

Contacts
Principal investigator
Name 118846 0
Ms Doaa Elwadiaa
Address 118846 0
Liverpool Cancer Therapy Centre
Corner Goulburn and Campbell Streets
Liverpool NSW 2170
Country 118846 0
Australia
Phone 118846 0
+61 2 8738 9148
Fax 118846 0
+61 2 8738 9205
Email 118846 0
[email protected]
Contact person for public queries
Name 118847 0
Penny Phan
Address 118847 0
Ingham Institute
1 Campbell Street, Liverpool NSW 2170
Country 118847 0
Australia
Phone 118847 0
+61 2 8738 9148
Fax 118847 0
+61 2 8738 9205
Email 118847 0
[email protected]
Contact person for scientific queries
Name 118848 0
Robba Rai
Address 118848 0
Liverpool Cancer Therapy Centre
Corner Goulburn and Campbell Streets
Liverpool NSW 2170
Country 118848 0
Australia
Phone 118848 0
+61 2 8738 9148
Fax 118848 0
+61 2 8738 9205
Email 118848 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
15823Study protocol  [email protected]



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.