ANZCTR - Registration

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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]

None

Universal Trial Number (UTN)

Trial acronym

CALD

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Cancer

Condition category

Condition code

Cancer

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]

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]

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]

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]

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]

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?

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

Final

Recruitment in Australia

Recruitment state(s)

NSW

Recruitment hospital [1]

Liverpool Hospital - Liverpool

Recruitment hospital [2]

Campbelltown Hospital - Campbelltown

Recruitment hospital [3]

Bankstown-Lidcombe Hospital - Bankstown

Recruitment postcode(s) [1]

2170 - Liverpool

Recruitment postcode(s) [2]

2560 - Campbelltown

Recruitment postcode(s) [3]

2200 - Bankstown

Funding & Sponsors

Funding source category [1]

University

Name [1]

University Of New South Wales

Address [1]

UNSW Sydney
High St
Kensington, NSW 2052
Australia

Country [1]

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]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

South Western Sydney Local Health District

Ethics committee address [1]

Locked Bag 7103 Liverpool BC NSW 1871

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

28/09/2020

Approval date [1]

09/11/2020

Ethics approval number [1]

Summary

Brief summary

Cancer Services at South Western Sydney Local Health District (SWSLHD) have a diverse spectrum of patients with 18.5% of patients coming from a culturally and linguistically diverse (CALD) background. However, previous investigations in this cohort determined that trial participation was significantly lower in CALD patients (5.7%) compared to non-CALD patients (8.4%). The radiation oncology department at SWSLHD has a number of recruiting clinical trials that involve investigations surrounding the incorporation of magnetic resonance imaging (MRI) into routine radiotherapy planning and delivery. Literature indicates that barriers to CALD participation in clinical trials include communication and health literacy concerns. Therefore, the aim of this study is to assess the feasibility of providing translated educational materials to CALD patients, and the effect that this has on CALD patient recruitment to clinical trials of MRI in radiotherapy.

Who is it for?
You may be eligible for this study if you are aged 18 years or older, are attending the Liverpool, Campbelltown, or Bankstown Cancer Therapy Centre Clinics for a Radiation Oncology Consultation, and are of Chinese, Arabic or Vietnamese background requiring interpretive services.

Study details
All participants will receive educational materials that are translated into their native language. The materials will be delivered face to face, and will include a 5-minute video and a brochure containing standard patient MRI information. Before and after receiving these materials, participants will be administered a survey to assess their willingness to participate in clinical trials of MRI in radiotherapy. The recruitment rate of CALD patients to these trials will also be assessed at the end of the study, as well as the influence of the educational materials on recruitment rates.

It is hoped that this study may show that providing translated educational materials to CALD individuals is feasible, and may improve rates of recruitment to clinical trials in this population.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Ms Doaa Elwadiaa

Address

Liverpool Cancer Therapy Centre
Corner Goulburn and Campbell Streets
Liverpool NSW 2170

Country

Australia

Phone

+61 2 8738 9148

Fax

+61 2 8738 9205

doaa.elwadiaa@health.nsw.gov.au

Contact person for public queries

Name

Penny Phan

Address

Ingham Institute
1 Campbell Street, Liverpool NSW 2170

Country

Australia

Phone

+61 2 8738 9148

Fax

+61 2 8738 9205

SWSLHD-RadOncClinicalTrials@health.nsw.gov.au

Contact person for scientific queries

Name

Robba Rai

Address

Liverpool Cancer Therapy Centre
Corner Goulburn and Campbell Streets
Liverpool NSW 2170

Country

Australia

Phone

+61 2 8738 9148

Fax

+61 2 8738 9205

robba.rai@health.nsw.gov.au

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

No/undecided IPD sharing reason/comment

What supporting documents are/will be available?

Doc. No.	Type	Citation	Link	Email	Other Details	Attachment
15823	Study protocol			SWSLHD-RadOncClinicalTrials@health.nsw.gov.au

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.

Trial Review

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