Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618001652268
Ethics application status
Approved
Date submitted
27/09/2018
Date registered
5/10/2018
Date last updated
15/02/2021
Date data sharing statement initially provided
15/02/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
A randomised controlled trial of telephone call versus letter recalls for cervical screening and mammography for Aboriginal women to improve uptake of screening


Scientific title
A randomised controlled trial of telephone call versus letter recalls for cervical screening and mammography for Aboriginal women to improve uptake of screening
Secondary ID [1] 296174 0
Nil
Universal Trial Number (UTN)
U1111-1221-1511
Trial acronym
IAMS CCT Recall Project
Linked study record
Not applicable

Health condition
Health condition(s) or problem(s) studied:
cervical cancer 309800 0
breast cancer 309801 0
Condition category
Condition code
Cancer 308595 308595 0 0
Cervical (cervix)
Cancer 308596 308596 0 0
Breast
Public Health 308654 308654 0 0
Other public health

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention group will receive a telephone call, followed by 2 SMS reminders (stating that the woman is due for a cervical screening test or mammogram and giving details for booking screening) a week apart if they do not respond.
Participants will include women who are eligible for cervical screening (women aged 25-74) and mammography (50-74) and who were recorded as being due on the health service's electronic medical record.
The intervention will be administered by staff of the Illawarra Aboriginal Medical Service cancer care team.
Intervention code [1] 312504 0
Early detection / Screening
Comparator / control treatment
Letter recall for cervical screening and mammograms (standard care)
Control group
Active

Outcomes
Primary outcome [1] 307555 0
Completion of cervical screening if eligible and due for test (as measured by cervical screening result recorded on medical record)
Timepoint [1] 307555 0
Within 3 months of intervention
Primary outcome [2] 307585 0
Completion of mammography if eligible and due for test (as measured by mammogram result recorded on medical record)
Timepoint [2] 307585 0
Within 3 months of intervention
Secondary outcome [1] 352286 0
Appointment made in electronic medical record for cervical screening if eligible or due
Timepoint [1] 352286 0
Within 3 months of intervention
Secondary outcome [2] 352371 0
Appointment made for mammography recorded in electronic medical record if eligible or due
Timepoint [2] 352371 0
Within 3 months of intervention
Secondary outcome [3] 352427 0
Cost effectiveness (comparison of estimated labour costs, postage or telephone call costs per successful recall)
Timepoint [3] 352427 0
3 months post - intervention

Eligibility
Key inclusion criteria
Eligibility for national prevention campaigns (women aged 25-74 for cervical screening and women aged 50-74 for mammography) and clients of the Illawarra Aboriginal Medical Service
Minimum age
25 Years
Maximum age
74 Years
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Women presenting with symptoms or signs of cervical cancer or breast cancer who require diagnostic tests rather than screening tests

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Randomisation is via computerised randomisation system. Allocation is not concealed to those booking tests or to participants. Allocation is concealed to those collecting data for test completion (cervical screening and mammography).
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Sample size- we estimated sample size using perceived prevalence of response from pilot to phone call 50% and to letter 10%, alpha 0.05, beta 0.2, with randomisation to equal sized groups, resulting in calculated sample size of 72.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
23/10/2018
Actual
23/10/2018
Date of last participant enrolment
Anticipated
14/12/2018
Actual
28/02/2019
Date of last data collection
Anticipated
14/03/2019
Actual
31/05/2019
Sample size
Target
80
Accrual to date
Final
376
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 300766 0
University
Name [1] 300766 0
University of Wollonging, School of Medicine
Country [1] 300766 0
Australia
Primary sponsor type
Other
Name
Illawarra Aboriginal Medical Service
Address
150 Church St, Wollongong NSW 2500
Country
Australia
Secondary sponsor category [1] 300305 0
None
Name [1] 300305 0
Address [1] 300305 0
Country [1] 300305 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 301546 0
Aboriginal Health and Medical Research Council Ethics Committee
Ethics committee address [1] 301546 0
Ethics committee country [1] 301546 0
Australia
Date submitted for ethics approval [1] 301546 0
22/11/2017
Approval date [1] 301546 0
30/07/2018
Ethics approval number [1] 301546 0
1420/18

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

Contacts
Principal investigator
Name 87346 0
A/Prof Rowena Ivers
Address 87346 0
Illawarra Aboriginal Medical Service
150 Church St ,
Wollongong NSW 2500
Country 87346 0
Australia
Phone 87346 0
+61 2 42299495
Fax 87346 0
+61 2 42286153
Email 87346 0
[email protected]
Contact person for public queries
Name 87347 0
Rowena Ivers
Address 87347 0
Illawarra Aboriginal Medical Service
150 Church St ,
Wollongong NSW 2500
Country 87347 0
Australia
Phone 87347 0
+61 2 42299495
Fax 87347 0
+61 2 42286153
Email 87347 0
[email protected]
Contact person for scientific queries
Name 87348 0
Rowena Ivers
Address 87348 0
Illawarra Aboriginal Medical Service
150 Church St ,
Wollongong NSW 2500
Country 87348 0
Australia
Phone 87348 0
+61 2 42299495
Fax 87348 0
+61 2 42286153
Email 87348 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
Intellectual property of Aboriginal service


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
EmbaseCervical Screening Reminders for Aboriginal and Torres Strait Islander Women in Primary Care-Randomised Controlled Trial of Letter vs. Phone/SMS Reminders.2023https://dx.doi.org/10.3390/ijerph20136257
N.B. These documents automatically identified may not have been verified by the study sponsor.