Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000875404
Ethics application status
Approved
Date submitted
23/07/2025
Date registered
12/08/2025
Date last updated
12/08/2025
Date data sharing statement initially provided
12/08/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
Can revising National Bowel Cancer Screening Program materials or shifting from a mail-out model to a kit request model improve participation rates among individuals who have never screened?
Scientific title
Testing interventions to increase participation in the National Bowel Cancer Screening Program (NBCSP) among persistent never-screeners.
Secondary ID [1] 314227 0
Funded by the National Health and Medical Research Council Synergy grant (ID: 2010268)
Universal Trial Number (UTN)
The Universal Trial Number (UTN) is U1111-1321-6585
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
colorectal cancer 337148 0
Condition category
Condition code
Cancer 333568 333568 0 0
Bowel - Back passage (rectum) or large bowel (colon)
Public Health 333570 333570 0 0
Other public health

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The trial is testing two interventions which are modifications to the National Bowel Cancer Screening Program (NBCSP).
Trial arm 1 (intervention 1): A modified pre invitation letter will be sent providing instructions for how the participant can request their NBCSP kit. The letter is double-sided, can be read in five minutes and the front page is in English. It is personalised to include the person’s first name, provides reasons for doing to the test, contains a QR code to request a kit, provides simple (visual) instructions for how to do the test, and has a second QR code for more information on the NBCSP. The back of the letter has instructions for how to access information on the NBCSP in languages other than English. This is standard information provided with program letters. The number of NBCSP kits requested and returned will be used to determine the adherence to the intervention.
Trial arm 2 (intervention 2): A screening kit will be sent with revised invitation-to-screen material including:
1. A modified invitation letter with the following changes:
- An added statement highlighting they are at increased risk of colorectal cancer because they have not done previous NBCSP kits, and
- A QR code with a link to a website with additional information to help address common barriers to screening. The website has been developed specifically for this study by the study team. The website will be situated on the Department of Health, Disability and Ageing website. It will be an orphan site that is only accessed using either the supplied QR code or directly typing in the URL. It is not searchable or able to be accessed from the departmental or program website. Visits to the website will be monitored using google analytics.
- The back of the letter has instructions for how to access information on the NBCSP in languages other than English. This is standard information provided with program letters.
2. A modified outer envelope which has removed any information about bowel cancer screening from the front of the envelope and added the words ‘Important information about your health inside’ printed in English and six other languages (Greek, Arabic, Vietnamese, Hindi, Mandarin, and Italian). The number of NBCSP kits returned will be used to determine the adherence to the intervention.
Trial arm 3: control arm.
Intervention code [1] 330849 0
Early detection / Screening
Comparator / control treatment
Trial Arm 3 is the control arm. The participants in this arm of the trial will receive the standard pre-invitation letter 4-6 weeks prior to receiving their NBCSP kit. The standard pre-invitation letter is one double-sided page. It is personalised with the participant’s name, explains the test is free, clean and easy to do, and why they are being invited to do the test. It also says that the kit will arrive in 4-6 weeks. The letter includes a phone number and website for seeking more information on the NBCSP.
The back of the letter has instructions for how to access information on the program in languages other than English. This is standard information provided with program letters.
The standard kit will be sent 4-6 weeks later. This includes an invitation letter that is double-sided, can be read in five minutes and the front page is in English. It is personalised with the person’s first name, it explains why to do the test, provides simple (visual) instructions for how to do the test, and has two QR codes, one for an instructional video and one for more information on the NBCSP. The back of the letter has instructions for how to access information on the program in languages other than English. This is standard information provided with program letters.

The NBCSP kit includes everything needed to do the test: a form for the participant to complete, 2 toilet liners; 2 collection tubes; 1 ziplock bag; 1 reply paid envelope (to send the samples and form back).
Control group
Active

Outcomes
Primary outcome [1] 342207 0
Proportion of participants who returned a NBCSP kit, during the follow-up time-period as recorded in the National Cancer Screening Register (NCSR), by trial arm.
Timepoint [1] 342207 0
At the end of the 6-month follow-up period.
Secondary outcome [1] 449962 0
Proportion of participants who returned a NBCSP kit as recorded by the NCSR.
Timepoint [1] 449962 0
At the end of the 6-month follow-up period.
Secondary outcome [2] 449991 0
The time to kit return as recorded by the NCSR.
Timepoint [2] 449991 0
At the end of the 6-month follow-up period.

Eligibility
Key inclusion criteria
Persistent never screeners in the 56 -74 year old cohort who are due to screen during the trial enrolment period. Persistent never screeners are defined as people who have been eligible for at least three consecutive screening rounds and never returned a NBCSP kit.
Minimum age
56 Years
Maximum age
74 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
People who have either permanently or temporarily opted out from the NBCSP (e.g. if they have chosen not to screen), or deferred their screening (e.g. are travelling).
People whose kit will not be sent as they live in a hot area (during summer, some geographical areas are not sent NBCSP kits as the heat can impact the test).
People who have been diagnosed with colorectal cancer.
People who have had a colonoscopy.

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)
Central randomisation by computer.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated sequence for trial arm randomisation. Simple randomisation will be used.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
18/08/2025
Actual
Date of last participant enrolment
Anticipated
21/09/2025
Actual
Date of last data collection
Anticipated
3/05/2026
Actual
Sample size
Target
60000
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 318743 0
Government body
Name [1] 318743 0
Australian Department of Health, Disability and Ageing
Country [1] 318743 0
Australia
Funding source category [2] 319489 0
Government body
Name [2] 319489 0
NHMRC
Country [2] 319489 0
Australia
Primary sponsor type
University
Name
The University of Melbourne
Address
Country
Australia
Secondary sponsor category [1] 321978 0
Government body
Name [1] 321978 0
Australian Department of Health, Disability and Ageing
Address [1] 321978 0
Country [1] 321978 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 317358 0
University of Melbourne Central Human Research Ethics Committee
Ethics committee address [1] 317358 0
Ethics committee country [1] 317358 0
Australia
Date submitted for ethics approval [1] 317358 0
06/11/2024
Approval date [1] 317358 0
12/03/2025
Ethics approval number [1] 317358 0
2025-31380-63704-4

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

Contacts
Principal investigator
Name 140790 0
Prof Mark Jenkins
Address 140790 0
Melbourne School of Population and Global Health, The University of Melbourne, Grattan Street, Parkville, Victoria 3010, Australia
Country 140790 0
Australia
Phone 140790 0
+61 407756012
Fax 140790 0
Email 140790 0
[email protected]
Contact person for public queries
Name 140791 0
Mark Jenkins
Address 140791 0
Melbourne School of Population and Global Health, The University of Melbourne, Grattan Street, Parkville, Victoria 3010, Australia
Country 140791 0
Australia
Phone 140791 0
+61 407756012
Fax 140791 0
Email 140791 0
[email protected]
Contact person for scientific queries
Name 140792 0
Mark Jenkins
Address 140792 0
Melbourne School of Population and Global Health, The University of Melbourne, Grattan Street, Parkville, Victoria 3010, Australia
Country 140792 0
Australia
Phone 140792 0
+61 407756012
Fax 140792 0
Email 140792 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No
No IPD sharing reason/comment: These data will remain confidential. The data will be under the responsibility of the NCSR data custodian, Ms Perdi Mitchell, Dept of Health, Disability and Ageing and as this is sensitive health data it will not be shared.



What supporting documents are/will be available?

TypeCitationLinkEmailOther DetailsAttachment
Ethical approval    2025-31380-63704-4 .pdf


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.