The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR

Registration number
Ethics application status
Date submitted
Date registered
Date last updated
Type of registration
Retrospectively registered

Titles & IDs
Public title
The value of an advance notification letter prior to a postal offer of bowel cancer screening on population participation in screening.
Scientific title
The value of an advance notification letter prior to a postal offer of bowel cancer screening on population participation in screening.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Screening for bowel cancer 325 0
Condition category
Condition code
Cancer 371 371 0 0
Bowel - Anal
Cancer 372 372 0 0
Bowel - Back passage (rectum) or large bowel (colon)

Study type
Description of intervention(s) / exposure
A bowel cancer screening program that incorporates a preliminary letter to notify an invitee that they will be shortly sent an invitation to participate.
Intervention code [1] 246 0
Comparator / control treatment
An offer that does not include the preliminary letter.
Control group

Primary outcome [1] 432 0
Completion of faecal immunochemical test expressed as the population participation rate.
Timepoint [1] 432 0
Within 12 weeks of offer.
Secondary outcome [1] 945 0
Test positivity rate
Timepoint [1] 945 0
12 weeks from invitation
Secondary outcome [2] 946 0
Yield of neoplasia
Timepoint [2] 946 0
12 weeks from invitation

Key inclusion criteria
Present on the electoral roll of the Australian Electoral Commission, who reside in one of a set of defined postcodes adjacent to Flinders Medical Centre or Repatriation General Hospital Daw Park.
Minimum age
50 Years
Maximum age
74 Years
Both males and females
Can healthy volunteers participate?
Key exclusion criteria
People already participating in bowel cancer screening research and service programs coordinated from the Bowel Health Service, Repartiation General Hospital Daw Park.Self exclusion by invitees - people who have specific heart and lung conditions that would preclude them from diagnostic and surgical follow-up following a positive screening test. All people who have specific medical conditions that would invalidate the screening test results. All people who have had a colonoscopy or stool screening test within the last year.

Study design
Purpose of the study
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Invitees are randomised to a screening program with preliminary notification letter or without. Invitations to participate are sent by mail, there is no direct interpersonal contact. Help line calls are answered without knowledge of intervention group.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Group sizes of 600 each were determined by power analysis assuming that an intervention that produces a 10% increase in participation over control is a significant program improvement. All eligible people 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, the second 600 to control group.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?

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

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

Funding & Sponsors
Funding source category [1] 430 0
Government body
Name [1] 430 0
NHMRC Project grant 324717
Address [1] 430 0
GPO Box 1421
Canberra ACT 2601
Country [1] 430 0
Primary sponsor type
Prof. Graeme Young MD, FRACP
Dept of Gastroenterology
Flinders Medical Centre
Secondary sponsor category [1] 348 0
Name [1] 348 0
Mr Stephen Cole
Address [1] 348 0
Bowel Health Service
Repatriation General Hospital
Country [1] 348 0

Ethics approval
Ethics application status
Ethics committee name [1] 1400 0
Repatriation General Hospital Daw Park
Ethics committee address [1] 1400 0
Daws Rd, Daw Park, SA 5041
Ethics committee country [1] 1400 0
Date submitted for ethics approval [1] 1400 0
Approval date [1] 1400 0
Ethics approval number [1] 1400 0

Brief summary
Improved participation in screening for bowel cancer is desirable. Currently population scale bowel cancer screening program delivery is by mailed offer, without prior warning, from a central screening service and invitations include a occult blood kit. Invitees may reject this process as they are unprepared to receive such an offer. One approach is to improve communication between screening providers and invitees through improved population scale interpersonal contact.
We have developed a preliminary letter to precede an postal invitation to bowel cancer screening. The letter simply informs invitees that they will soon receive a screening invitation and provides them with some basic information about bowel cancer screening. We will randomly select invitees from the electoral roll and compare population screening participation between groups with or without the preliminary letter to determine which program results in the greater participation rate. Improved participation in screening will ultimately reduce deaths from bowel cancer
Trial website
Trial related presentations / publications
Public notes

Principal investigator
Name 35912 0
Address 35912 0
Country 35912 0
Phone 35912 0
Fax 35912 0
Email 35912 0
Contact person for public queries
Name 9435 0
Ms Alicia Smith
Address 9435 0
Bowel Health Service
Repatriation General Hospital Daw Park
Daws Rd
Daw Park SA 5041
Country 9435 0
Phone 9435 0
+61 8 82751075
Fax 9435 0
+61 8 82751083
Email 9435 0
Contact person for scientific queries
Name 363 0
Mr Stephen Cole
Address 363 0
Bowel Health Service
Repatriation General Hospital Daw Park
Daws Rd
Daw Park SA 5041
Country 363 0
Phone 363 0
+61 8 82751838
Fax 363 0
+61 8 82751083
Email 363 0

No data has been provided for results reporting
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