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Trial registered on ANZCTR


Registration number
ACTRN12605000462684
Ethics application status
Approved
Date submitted
9/09/2005
Date registered
22/09/2005
Date last updated
22/09/2005
Type of registration
Retrospectively registered

Titles & IDs
Public title
The influence of initial screening test technology on participation in rescreening for colorectal cancer
Scientific title
The influence of initial screening test technology on participation in rescreening for colorectal cancer
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Screening for bowel cancer 579 0
Condition category
Condition code
Cancer 653 653 0 0
Bowel - Back passage (rectum) or large bowel (colon)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The aim is to determine the effect of the type of test offered in a first round of a screening program for colorectal cancer on participation in a second round.
Group 1: First round of screening Hemoccult II Sensa, low technology test. Second round of screening: InSure test, high technology.
Group 2: First round of screening: FlexSure OBT, mid technology test. Second round: InSure OBT, high technology.
Group 3: First round of screening: InSure OBT, high technology test. Second round: InSure OBT, high technology.
Intervention code [1] 445 0
Early detection / Screening
Comparator / control treatment
Control group
Active

Outcomes
Primary outcome [1] 773 0
Paricipation in screening defined as return of a screening kit 12 weeks from offer.
Timepoint [1] 773 0
Secondary outcome [1] 1567 0
Test positivity rate
Timepoint [1] 1567 0
Secondary outcome [2] 1568 0
Yield of neoplasia
Timepoint [2] 1568 0

Eligibility
Key inclusion criteria
First round of screeningInclusion: Present on the electoral roll of the South Australian Electoral Commission on 01/02/2001.
Minimum age
50 Years
Maximum age
69 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
None but invitees provided with a list of conditions and settings where faecal occult blood based screening is inappropriate and requesting self-exclusion by not participating.Second round of screening.Inclusion: Selected for the first round of screening invitationsExclusion: People identified during Round 1 as having gastrointestinal conditions that invalidate screening results, people identified with mental and physical disabilities that prevent them from following the study protocol, people known to have had a neoplasia negative colonoscopy 5 years prior to a screening offer, people whose first round kits were returned unopened and 'not known at this address', people who informed the screening facility that they did not want further contact.

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)
Invitees are randomised to one of 3 invitation groups that differed by the type of screening test offered. The tests varied by level of technology. Allocation to invitation group was not concealed from the investigators and office staff who printed and packaged invitation kits for postal delivery, but there was no direct contact between investigators and invitees. Invitees were unaware that there was more than one test type. A help line was available and inquiries were answered without knowledge of test type.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
roup sizes of 606 each were determined by power analysis assuming that an intervention that produces a 10% increase in participation over control is a significant program improvement. For the first round of offers: The electoral office provided a listing of all people in selected postcodes adjacent to the catchment area of Flinders Medical Centre and the Repatriation General Hospital Daw Park. They were assigned a random number using the MicroSoft Excel RAND function. The listing was ordered by ascending random number. The first 600 people were assigned to the Intervention group 1 the second 600 to Intervention group 2 and the third 600 to the Intervention group 3
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint(s)
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
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)

Funding & Sponsors
Funding source category [1] 720 0
Charities/Societies/Foundations
Name [1] 720 0
Bushel Fund
Address [1] 720 0
Country [1] 720 0
Primary sponsor type
Individual
Name
Prof. Graeme Young MD, FRACP
Address
Country
Secondary sponsor category [1] 598 0
Individual
Name [1] 598 0
Mr Stephen Cole
Address [1] 598 0
Country [1] 598 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 1920 0
Repatriation General Hospital Daw Park
Ethics committee address [1] 1920 0
Daws Rd, Daw Park, SA 5041
Ethics committee country [1] 1920 0
Australia
Date submitted for ethics approval [1] 1920 0
Approval date [1] 1920 0
Ethics approval number [1] 1920 0

Summary
Brief summary
Colorectal cancer population screening programs commonly suffer from poor participation. Therefore it is important to reduce as many barriers as possible. Some screening tests affect participation, this is associated with level of technology. As screening most effective when conducted regularly, it is important to determine the impact of the initial screening experience on participation in further rounds.
This study determined the impact of the level of technology of the test used in the first round of offers on participation in a second round where all people were offered the test that elicited the highest participation in the first round (ie the 'preferred' test.
In the first round there were 3 groups each offered sceening using a different test. Intervention group 1 used Hemoccult II Sensa, a low technology guaiac based test requiring restricted diet for 6 days, sampling stool by spatula and 6 applications of stool to collection device, Intervention group 2 used FlexSure OBT, a mid level technology immunochemical test without restricted diet, sampling stool by spatula, 3 applications of stool to collection device, Intervention group 3 used InSure OBT, high level technology- immunochemical test, without diet, sampling stool by brush, 2 applications of stool sample. Intervention group 3 (InSure) returned the highest participation and was thus considered the preferred test. All people received Insure in the second round of offers.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35746 0
Address 35746 0
Country 35746 0
Phone 35746 0
Fax 35746 0
Email 35746 0
Contact person for public queries
Name 9634 0
Ms Alicia Smith
Address 9634 0
Bowel Health Service
Repatriation General Hospital Daw Park
Daws Rd
Daw Park SA 5041
Country 9634 0
Australia
Phone 9634 0
+61 8 82751075
Fax 9634 0
+61 8 02751083
Email 9634 0
alicia.smith@rgh.sa.gov.au
Contact person for scientific queries
Name 562 0
Mr Stephen Cole
Address 562 0
Bowel Health Service
Repatriation General Hospital Daw Park
Daws Road
Daw Park SA 5041
Country 562 0
Australia
Phone 562 0
+61 8 82751838
Fax 562 0
+61 8 82751083
Email 562 0
scoles@rgh.sa.gov.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary