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Trial registered on ANZCTR


Registration number
ACTRN12615000972527
Ethics application status
Approved
Date submitted
2/09/2015
Date registered
17/09/2015
Date last updated
9/04/2019
Date data sharing statement initially provided
10/12/2018
Date results information initially provided
10/12/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Bowel cancer screening participation rate in a program that offers blood tests as well as faecal tests as screening options.
Scientific title
Will people from the general population, who are offered a bowel cancer screening program that includes a blood test in addition to faecal occult blood test, participate at a significantly greater rate relative to people offered a screening program consisting of faecal tests only?
Secondary ID [1] 287394 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Colorectal cancer 296108 0
Condition category
Condition code
Public Health 296364 296364 0 0
Health service research
Cancer 296365 296365 0 0
Bowel - Back passage (rectum) or large bowel (colon)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention is a bowel cancer screening program that includes the availability of a screening blood test after an offer of the standard faecal occult blood test (FOBT).

There are two intervention groups (n = 600 per group). Everyone in the intervention will be initially mailed an offer of screening for bowel cancer by FOBT. For the first intervention group, after 12 weeks anyone who has not participated with the FOBT will be mailed an offer of screening for bowel cancer by blood test (the methylated BCAT1/IKZF1 blood test). They will then need to call the study helpline to request a further blood test information.
The second intervention group will be sent the offer for the blood test at the same time as receiving the FOBT. They will be advised that if they believe that the FOBT is not suitable for them they might consider screening for bowel cancer by blood test. They will then need to call the study helpline to request a further blood test information.

Anyone requesting the blood test will then be sent information about the test (including accuracy of the test, where they can get their blood collected, and when they will receive their test results) and a test referral. They can then take up the offer of the free screening blood test at one of 10 local blood collection centres (Healthscope). They do not need to be fasted and appointments do not need to be made.

Reminder letters will be sent to non-participants 6 weeks after each type of screening test offer.

Participants of the FOBT will be required to collect a small sample from two separate bowel movements. These samples are then sent via reply-paid mail to a laboratory which tests the samples for the presence of blood. If more than 100ng/mL of blood is present in either sample, than the participant will be sent a positive result letter (which will be copied to their GP) to advise further investigations.

Participants of the blood test will need to attend a Healthscope collection centre and have 18mL of blood collected. This will be sent to a laboratory for analysis. If methylated BCAT1 or IKZF1 are detected in the blood sample then the participant will be sent a positive result letter (which will be copied to their GP) to advise further investigations.

Total screening participation rate with either the FOBT or the blood test will be assessed at 24 weeks after the start of the study (12 weeks after the blood test offer).

Round 2: to examine participation and re-participation over two rounds of colorectal cancer screening offers. The same cohort (participants and non-participants who did not withdraw/opt-out from the study) will be contacted in this Round. This will assess whether non-participants can be encouraged to participate by offering more choice of test up front, thereby ‘rescuing’ people who may not participate from a single screening offer, or from a FOBT offer only.

Round 3:
In Round 1 and 2, participants were enrolled into the study and offered either a blood test or an FOBT bowel cancer screening test.
After all participants were enrolled and the results were analysed, approximately 100 participants were found to have a positive bowel cancer screening result. These 100 participants, and their General Practitioners, were sent a letter informing them of their positive result with a recommendation to consider further investigation for colorectal cancer (CRC) screening, by way of a colonoscopy (which is the gold standard). We would now like to determine how many participants have had follow-up investigations after a positive CRC screening test, and further evaluate diagnostic accuracy of each test type.
Intervention code [1] 292756 0
Early detection / Screening
Comparator / control treatment
As for the Intervention group, the Control group (n = 600) will be initially mailed an offer of screening for bowel cancer by FOBT. Reminder letters will be sent after 6 weeks and after 12 weeks, anyone who has not participated with the FOBT will be mailed another offer to screen using the FOBT. They will then need to call the study helpline to request a FOBT to be posted to them.

Total screening participation with the FOBT in the control group will be determined.
Control group
Active

Outcomes
Primary outcome [1] 296013 0
Total participation rate in a bowel cancer screening program that offers a FOBT followed by a blood test, compared to a program that only offers FOBT. This will be assessed at the 24 week timepoint by review of laboratory records.
Timepoint [1] 296013 0
24 weeks after the initial screening offer.
Secondary outcome [1] 317230 0
Screening participation rate with a blood test compared to a second offer of a FOBT. This will be determined by review of laboratory records.
Timepoint [1] 317230 0
Screening participation from week 13 to week 24.
Secondary outcome [2] 317231 0
The proportion of people who can not participate with FOBT due to medical conditions. This will be determined through the review of feedback from participants- either from their mailed feedback or from their comments to the study helpline.
Timepoint [2] 317231 0
Week 24.
Secondary outcome [3] 342835 0
To determine rates of participation adherence for those who participated in the first round of screening, with either the FOBT or the blood test.
Timepoint [3] 342835 0
24 months after initial enrolment the participants will be mailed the same screening offer as they completed in Round 1. The rates of participation is assessed over a period of 12 weeks (after sending the screening offer) calculated by the number of participants taking up the offer for blood screening or FOBT screening.
Secondary outcome [4] 342836 0
To investigate whether a second round of screening offer of blood test or FOBT can encourage participation among those who did not participate in the first round. The participation with the blood screening test versus FOBT will be analysed.
Timepoint [4] 342836 0
24 months after initial enrolment the study invitees will be randomised to receive the blood test, FOBT or a choice of either. The rates of participation is assessed over a period of 12 weeks (after sending the screening offer) calculated by the number of participants taking up the offer for blood screening or FOBT screening.
Secondary outcome [5] 369175 0
To further investigate the results from participants in rounds 1 & 2, who returned a positive blood or FOBT colorectal cancer screening test. The number of positive results that were generated was approximately 100. These participants, and their General Practitioners, were sent a letter recommending them to have further investigations, such as, a colonoscopy, which is the gold standard. The researchers would like to quantify and assess the behaviour of participants who showed a positive CRC screening test result and ensure all participants were followed up appropriately. We will assess the results by linking the colonoscopy data which will be accessed via the participants general practitioner after gaining consent to do so.
Timepoint [5] 369175 0
6 months after a positive letter was sent to the recipient.
Secondary outcome [6] 369176 0
To further investigate the results from participants in rounds 1 & 2, who returned a positive blood or FOBT colorectal cancer (CRC) screening test result. The number of positive results that were generated was approximately 100. These participants, and their General Practitioners, were sent a letter recommending them to have further investigations, such as, a colonoscopy, which is the gold standard. The researchers would like to ask for further consent to access the colonoscopy report and any pathology results from this investigation, to compare with the positive blood or stool result found from the study analysis. This will allow researchers to evaluate the accuracy of both tests used in the study to validate the sensitivity and specificity of the tests as CRC screening tools.
Timepoint [6] 369176 0
6 months after positive result sent to participant.

Eligibility
Key inclusion criteria
Randomly selected South Australians from the Australian Electoral Roll, aged 50-74y.
Minimum age
50 Years
Maximum age
74 Years
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
- Already up-to-date with screening (i.e. have completed a FOBT or had colonoscopy within the last 12 months)
- Unable to provide informed consent.

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)
800 names and addresses will be supplied by the Australian Electoral Commission. All names will be randomised to either control or one of two intervention groups (n=600/group). All selected subjects will be sent a FOBT to mirror the process by the National Bowel Cancer Screening Program. After 12 weeks, non-participants of the control and first intervention group will be then sent an offer of another FOBT (control group) or blood test (intervention 1 group). The second intervention group will be sent the blood test offer at the same time as the FOBT.

A second round of screening offers will be provided in Round 2 of the study 24 months after initial invitation. For the participants who completed either the blood test or FOBT in the first round of the study, they will be offered the same test again to assess adherence to screening. For those who did not complete any test in the first round of the study, they will be randomly allocated (by chance) an offer to screen with the blood test, the FOBT, or have a choice of the tests. Allocation to intervention is concealed and done via central randomisation by computer.

A third round of investigations will be commenced for approximately 100 participants (from round 1 and 2) who yeilded a positive blood or FOBT result. These participants will be contacted for consent to access pathology results from their colonoscopy to evaluate the diagnostic accuracy of each test type and to determine the colonoscopy uptake of those after a positive CRC screening test result.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A random number generator will be used within Excel to assign all names a random number. The lowest 600 random numbers will be allocated to the control group.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Type of endpoint(s)
Efficacy
Statistical methods / analysis
Chi-square tests will be used to compare participation rates between the groups.

For the main outcome of this study, overall program participation of the intervention arm should be at least 10% better than that in the control arm (to be clinically relevant). Based on previous studies, control arm participation will be 50% and therefore participation in the intervention arm would need to be at least 60%. A sample size of 600 per group (n = 1800 in total) will provide more than 90% power to detect a participation difference as small as 10% using a Chi-squared test of proportions and a Type I error rate of alpha = 0.05.

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA

Funding & Sponsors
Funding source category [1] 291968 0
Commercial sector/Industry
Name [1] 291968 0
Clinical Genomics
Address [1] 291968 0
Unit 15–16/ 2 Eden Park Drive
North Ryde
NSW 2113
Country [1] 291968 0
Australia
Funding source category [2] 291969 0
Charities/Societies/Foundations
Name [2] 291969 0
Cancer Council SA
Address [2] 291969 0
202 Greenhill Road
Eastwood
SA 5063
Country [2] 291969 0
Australia
Funding source category [3] 292975 0
Government body
Name [3] 292975 0
National Health and Medical Research Council
Address [3] 292975 0
Level 1, 16 Marcus Clarke Street Canberra ACT 2601
Country [3] 292975 0
Australia
Primary sponsor type
Individual
Name
Erin Symonds
Address
Bowel Health Service,
Level 3, Flinders Centre for Innovation in Cancer,
Flinders Drive,
Bedford Park,
South Australia 5042
Country
Australia
Secondary sponsor category [1] 290637 0
None
Name [1] 290637 0
Address [1] 290637 0
Country [1] 290637 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293465 0
Southern Adelaide Clinical Human Research Ethics Committee
Ethics committee address [1] 293465 0
Ward 6C, Room 6A219
Flinders Medical Centre
Flinders Drive
Bedford Park
South Australia 5042
Ethics committee country [1] 293465 0
Australia
Date submitted for ethics approval [1] 293465 0
21/11/2014
Approval date [1] 293465 0
31/08/2015
Ethics approval number [1] 293465 0
483.14

Summary
Brief summary
The primary purpose of this study is to determine whether offering a screening blood test to people who do not participate with standard faecal-based testing method can increase overall bowel cancer screening participation compared to a program that only offers a faecal occult blood test (FOBT).
Who is it for? Participants for this study will be randomly selected from the South Australian electoral roll, all between 50 and 74 years of age, who have not had an FOBT or colonoscopy carried out in the last 12 months.
Study details: All participants will be mailed an offer for FOBT, with a reminder letter sent 6 weeks later to non-participants. For those who will not or can not complete the FOBT, they will be randomly allocated (by chance) to receive an immediate offer of screening with a new blood test, or after 12 weeks will receive either another offer for screening with FOBT, or an offer to screen with the blood test. Additional reminder letters will be sent another 6 weeks later to non-participants. A second round of screening offers will be provided in Round 2 of the study 24 months after initial invitation. For the participants who completed either the blood test or FOBT in the first round of the study, they will be offered the same test again to assess adherence to screening. For those who did not complete any test in the first round of the study, they will be randomly allocated (by chance) an offer to screen with the blood test, the FOBT, or have a choice of the tests. Reminder letters will be sent after 6 weeks to people who have not completed a test. Rates of participation with the different tests will be determined 12 weeks after the screening offer.
It is hoped that the findings of this trial will aid understanding of whether a screening test for bowel cancer by blood test rather than faecal testing methods shows greater participation rates as well as adherence to ongoing screening, and thus whether this alternative method shows potential for reducing mortality from bowel cancer in the long term.

Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 60010 0
Dr Erin Symonds
Address 60010 0
Bowel Health Service,
Level 3, Flinders Centre for Innovation in Cancer,
Flinders Drive,
Bedford Park,
South Australia 5042
Country 60010 0
Australia
Phone 60010 0
+61 8 84042813
Fax 60010 0
Email 60010 0
Erin.Symonds@sa.gov.au
Contact person for public queries
Name 60011 0
Ms Gretchen Jean
Address 60011 0
Bowel Health Service,
Level 3, Flinders Centre for Innovation in Cancer,
Flinders Drive,
Bedford Park,
South Australia 5042
Country 60011 0
Australia
Phone 60011 0
+61 8 82751075
Fax 60011 0
Email 60011 0
gretchen.jean@health.sa.gov.au
Contact person for scientific queries
Name 60012 0
Dr Erin Symonds
Address 60012 0
Bowel Health Service,
Level 3, Flinders Centre for Innovation in Cancer,
Flinders Drive,
Bedford Park,
South Australia 5042
Country 60012 0
Australia
Phone 60012 0
+61 8 8404 2813
Fax 60012 0
Email 60012 0
Erin.Symonds@health.sa.gov.au

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?
Clinical study report
Summary results
Have study results been published in a peer-reviewed journal?
Yes
Other publications
Have study results been made publicly available in another format?
Yes
Results – basic reporting
Results – plain English summary