Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616001538437
Ethics application status
Approved
Date submitted
3/11/2016
Date registered
8/11/2016
Date last updated
8/11/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
INFORM: Improving Information and Communication for Migrants with Cancer
Scientific title
The development and testing of a complex intervention to improve outcomes in Culturally and Linguistically Diverse (CALD) cancer patients
Secondary ID [1] 290461 0
NIL
Universal Trial Number (UTN)
Trial acronym
INFORM
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cancer 300825 0
Condition category
Condition code
Cancer 300651 300651 0 0
Any cancer

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patients will be randomised 1:1 to either the intervention or usual care. The intervention consists of:

1) A Question Prompt List (QPL) translated into the participant’s own language
2) A copy of an audio-recording of one of the participant’s interpreted hospital consultations for the participant to take home and listen to.

The QPL is a paper-based list of commonly asked questions by people with cancer. It is posted to the participant a week prior to their hospital consultation.

The audio recording of the consultation is transferred to a USB stick immediately after the consultation and given to the patient to take home with them.
Intervention code [1] 296313 0
Other interventions
Comparator / control treatment
Usual clinical care. Usual clinical care in this context consists of the provision of an interpreter to interpret the consultation. There is very little or frequently no other resources offered to patients in their own language.
Control group
Active

Outcomes
Primary outcome [1] 300071 0
Methods, procedures and feasibility testing will be assessed within each language group (Arabic, Greek, Mandarin and Cantonese), as well as review of overall trial function. Testing will be achieved through completion of the following objectives.

1. Assessment of screening and recruitment processes
Including recruitment rates; inclusion/exclusion criteria; and adherence and withdrawal rates for patients, clinicians and interpreters.

2. Assessment of project resources
Including quality of translations; cultural acceptability of documents provided to patients; and usefulness and appropriateness of intervention materials including the QPL and audio-recording.

3. Assessment of project measures
Including quality of translations; questionnaire booklet suitability and completion rates; and the adequacy and appropriateness of the coding and matching process to the measurement application (assessment of information recall).

4. Assessment of design and procedures
Including interpreter bookings and cancellations; clinician availability and appointment delays; intervention delivery; and any additional unexpected culturally-specific aspects arising as part of the trial.

5. Assessment of time and costing
Including time spent by project team on recruitment, intervention delivery, questionnaire delivery, translation and transcription, patient contact and data management.
Timepoint [1] 300071 0
The outcomes will be assessed when the final participant has exited the study
Secondary outcome [1] 328938 0
Indication of intervention effectiveness, specifically, proportion of information from the consultation accurately recalled by the patient, will be assessed by inspecting the mean differences between study arms. These will also be estimated with 95% confidence intervals.
Timepoint [1] 328938 0
Two weeks post the administration of the intervention package (that is, the QPL and audio recording of the consultation).

Eligibility
Key inclusion criteria
- Aged 18+
- A patient of the oncology service at Northern Health or at PMCC in the following clinical services: Head and Neck, Lung, Urology, Gastrointestinal (Upper and Lower), Gynaecological, Haematological, and Bone and Soft Tissue
- Identified as speaking Arabic, Greek, Mandarin or Cantonese as their primary language, and speaks minimal English.
- Attending an appointment appropriate for audio-recording
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Diagnosed psychiatric disorder
- Too unwell
- Currently participating in another clinical trial
- Already noted/identified as requesting no information about diagnosis/prognosis/treatment
- Does not have a trial consented Cantonese, Mandarin, Greek, or Arabic interpreter booked for that consultation
- Does not have literacy skills in their primary language of Greek, Cantonese, Mandarin, or Arabic

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)
No
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomization stratified by site, language and gender
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
Data from Arabic, Greek, Mandarin and Cantonese speaking cancer patients will be analysed separately, because the outcome of feasibility assessment may be different for each language group. This information will be critical to the planning of a Phase III trial.

For each language group, descriptive statistics will be used to summarise demographic and clinical data and data relevant to the assessment of recruitment processes, project measures, design and procedures, and time and costing. These will be calculated and presented for each study arm separately as required.

Mean differences between study arms on information recall and information seeking will be estimated with 95% confidence intervals to ensure the level of uncertainty associated with each estimate is clear.

Mean differences between study arms on the remaining outcomes will be included for completeness only. These will also be estimated with 95% confidence intervals. After inspection of the data, the appropriateness of the stated methods will be revised if necessary.

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
Actual
1/06/2015
Date of last participant enrolment
Anticipated
Actual
30/06/2016
Date of last data collection
Anticipated
Actual
30/07/2016
Sample size
Target
80
Accrual to date
Final
40
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 294872 0
Government body
Name [1] 294872 0
NHMRC
Country [1] 294872 0
Australia
Primary sponsor type
Hospital
Name
Peter MacCallum Cancer Centre
Address
50 Grattan St Parkville VIC 3052
Country
Australia
Secondary sponsor category [1] 293710 0
None
Name [1] 293710 0
NONE
Address [1] 293710 0
Country [1] 293710 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296251 0
Peter MacCallum Cancer Centre HREC
Ethics committee address [1] 296251 0
50 Grattan St Parkville, VIC 3052
Ethics committee country [1] 296251 0
Australia
Date submitted for ethics approval [1] 296251 0
02/03/2015
Approval date [1] 296251 0
19/05/2015
Ethics approval number [1] 296251 0
14/145

Summary
Brief summary
Our team has recently completed two studies on the unmet needs, psychological morbidity, quality of life and patterns of care of 1483 people with cancer from Arabic, Greek and Chinese speaking backgrounds. Compared to English-speaking patients with cancer, patients from culturally and linguistically diverse (CALD) backgrounds had greater communication issues, unmet information needs and psychological distress. Without sound understanding and recall of information provided, patients cannot be actively involved in treatment decisions and provide informed consent to treatment. Our team has level I evidence which demonstrates that audio-recordings of consultations and question prompt lists (QPL) are highly effective in increasing recall and meeting information needs in English-speaking patients with cancer. This Phase II study will investigate whether this level I evidence can be used in applied to a CALD population. This study draws on the Medical Research Council (UK) framework for the development and evaluation of complex interventions.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 70154 0
Prof Penelope Schofield
Address 70154 0
Swinburne University of Technology
Burwood Rd. Hawthorn
VIC 3122
Country 70154 0
Australia
Phone 70154 0
+61-3-9214 4886
Fax 70154 0
Email 70154 0
pschofield@swib.edua.u
Contact person for public queries
Name 70155 0
Prof Penelope Schofield
Address 70155 0
Swinburne University of Technology
Burwood Rd. Hawthorn
VIC 3122
Country 70155 0
Australia
Phone 70155 0
+61-3-92144886
Fax 70155 0
Email 70155 0
pschofield@swin.edu.au
Contact person for scientific queries
Name 70156 0
Prof Schofield
Address 70156 0
Swinburne University of Technology
Burwood Rd. Hawthorn
VIC 3122
Country 70156 0
Australia
Phone 70156 0
+61-3-9214 4886
Fax 70156 0
Email 70156 0
pschofield@swin.edu.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

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

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseIncluding migrant oncology patients in research: A multisite pilot randomised controlled trial testing consultation audio-recordings and question prompt lists.2022https://dx.doi.org/10.1016/j.conctc.2022.100932
N.B. These documents automatically identified may not have been verified by the study sponsor.