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Trial registered on ANZCTR


Registration number
ACTRN12613001365752
Ethics application status
Approved
Date submitted
5/12/2013
Date registered
13/12/2013
Date last updated
13/12/2013
Type of registration
Retrospectively registered

Titles & IDs
Public title
A blood test for improving participation in bowel cancer screening
Scientific title
Will people at average risk for developing colorectal cancer, who are offered a screening program for colorectal cancer (CRC) that includes a blood test in addition to faecal occult blood tests (FOBT) participate at a significantly greater rate relative to people offered a screening program consisting of FOBT only.
Secondary ID [1] 283682 0
Nil known
Universal Trial Number (UTN)
U1111-1150-9448
Trial acronym
WolRes
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Colorectal cancer 290645 0
Condition category
Condition code
Cancer 291025 291025 0 0
Bowel - Back passage (rectum) or large bowel (colon)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention is a screening program for CRC that includes the availability of a blood test for CRC.

The intervention group are initially mailed an offer of screening for bowel cancer by FOBT.

At 12 weeks from date of the FOBT-screening offer, subjects who have not participated in FOBT-screening are mailed a second invitation to screen for CRC using a blood test for CRC.

Intervention group subjects contact the study Help-Line to request a referral to a pathology service for a blood to be taken for the blood test.
Intervention code [1] 288384 0
Early detection / Screening
Comparator / control treatment
The Control group are initially mailed an offer of screening for bowel cancer by FOBT.

At 12 weeks from date of the initial FOBT-screening offer, subjects who have not participated in FOBT screening are mailed a second invitation to screen for CRC using FOBT.

Control group subjects contact the study Help-Line to request a FOBT to be posted to them
Control group
Active

Outcomes
Primary outcome [1] 291013 0
Completion of a screening test for bowel cancer within a bowel cancer screening program.
Timepoint [1] 291013 0
12 weeks from written offer of a second screening test.
Secondary outcome [1] 305842 0
Completion of a screening test for CRC after having recently declined a faecal occult blood test.
Timepoint [1] 305842 0
12 weeks from written offer of second screening test for CRC.

Eligibility
Key inclusion criteria
General Practice patients
average risk for bowel cancer
Minimum age
50 Years
Maximum age
74 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Unable to provide informed consent.
Unsuitable for CRC screening as judged by the person's GP.
Medical record documented recent CRC screening within previous 2 years (FOBT/FIT; colonoscopy within 5 years) or participating in appropriate high risk CRC surveillance.
Patients who are likely to be sent a test from the NBCSP within the expected study duration.
Otherwise deemed unsuitable for screening offer by the GP (eg poor English language comprehension or inability to follow protocol).

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)
Patients receive a letter from their general practice inviting them to participate in a research study concerned with screening for bowel cancer.

The practice is unaware to which group their patient will be allocated.

Eligible patients who provide their signed consent are enrolled in the study
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Patients are listed on a MS Access database in order of firstly date of providing consent, and secondly alphabetical order of surname. The list is exported to Microsoft Excel.

Patients are assigned a random number using the RANDOM function of Microsoft Excel, the list is ordered in an ascending way and the list divided equally in two.
Patients in the half associated with the lower numbers are allocated to intervention 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
For the main objective, participation in the intervention group should be at least 10% greater than control across the program.

Expected participation rate for control Standard FOBT offer (Phase 1) plus additional participation from second offer (Phase 2) = 55%. This is based on NBCSP participation (average risk screening program) of <40%, influence of GP on participation = 10% above standard offer (Cole et al J Med Screen 2002;9:147-52), additional increment due to motivated population.

Expected participation for intervention = 50% from Phase 1 (same as Phase 1 control) plus 50% of Phase 2 = 75%. Second offer participation rate is based on preference for screening test specimen type data (Osborne et al Open J Prev Med 2012;2:326-331) and GP personal communication.

For the main objective A two group chi-square test (not Yates corrected) with a 0.050 two-sided significance level will have 80% power to detect a 10% difference between Group 1 proportion (control) of 0.550 and a Group 2 proportion (intervention) of 0.650 (odds ratio of 1.519) when the sample size in each group is 376.

For the secondary objective, a worthwhile improvement is seen as a 20% difference between the arms (this is equivalent to a 10% difference across the program if the phase 1 participation is 50%. Based on the prediction that Phase 2 participation in the control group will be 10%, intervention group participation would need to be at least 30%. A two group chi-square test (not Yates corrected) with a 0.050 two-sided significance level will have 80% power to detect the difference between a Group 1 proportion of 0.10 and a Group 2 proportion of 0.30 (odds ratio of 3.857) when the sample size in each group is 62.

To allow for lower participation in the intervention group, and/or improved power, we use group sizes of 600.

Statistical tests: Descriptive, Bivariate chi2, multivariate (GLM) to control for differences in population age, gender, SES, general practice affiliation

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
15/10/2013
Actual
15/10/2013
Date of last participant enrolment
Anticipated
10/12/2013
Actual
10/12/2013
Date of last data collection
Anticipated
Actual
Sample size
Target
1200
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA

Funding & Sponsors
Funding source category [1] 288370 0
Commercial sector/Industry
Name [1] 288370 0
Clinical Genomics
Country [1] 288370 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Clinical Genomics
Address
Riverside Life Sciences Building,
11 Julius Ave,
North Ryde,
NSW, 2113
Country
Australia
Secondary sponsor category [1] 287075 0
University
Name [1] 287075 0
Flinders University
Address [1] 287075 0
Sturt Road
Bedford Park 5042
South Australia
Country [1] 287075 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290252 0
Southern Adelaide Clinical Human Research Ethics Committee
Ethics committee address [1] 290252 0
Ethics committee country [1] 290252 0
Australia
Date submitted for ethics approval [1] 290252 0
Approval date [1] 290252 0
19/08/2013
Ethics approval number [1] 290252 0
422.13

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

Contacts
Principal investigator
Name 44682 0
Mr Stephen Cole
Address 44682 0
Bowel Health Service,
Repatriation General Hospital
216 Daws Road
Daw Park
SA 5041
Country 44682 0
Australia
Phone 44682 0
+61 8 82751838
Fax 44682 0
Email 44682 0
steve.cole@health.sa.gov.au
Contact person for public queries
Name 44683 0
Stephen Cole
Address 44683 0
Bowel Health Service,
Repatriation General Hospital
216 Daws Road
Daw Park
SA 5041
Country 44683 0
Australia
Phone 44683 0
+61 8 82751838
Fax 44683 0
Email 44683 0
steve.cole@health.sa.gov.au
Contact person for scientific queries
Name 44684 0
Stephen Cole
Address 44684 0
Bowel Health Service,
Repatriation General Hospital
216 Daws Road
Daw Park
SA 5041
Country 44684 0
Australia
Phone 44684 0
+61 8 82751838
Fax 44684 0
Email 44684 0
steve.cole@health.sa.gov.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
EmbaseUptake of a colorectal cancer screening blood test in people with elevated risk for cancer who cannot or will not complete a faecal occult blood test.2018https://dx.doi.org/10.1097/CEJ.0000000000000352
N.B. These documents automatically identified may not have been verified by the study sponsor.