Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12605000239662
Ethics application status
Approved
Date submitted
24/08/2005
Date registered
31/08/2005
Date last updated
14/09/2007
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)

Intervention/exposure
Study type
Interventional
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
Behaviour
Comparator / control treatment
An offer that does not include the preliminary letter.
Control group
Active

Outcomes
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

Eligibility
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
Sex
Both males and females
Can healthy volunteers participate?
Yes
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
Prevention
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
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
1/01/2005
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
1200
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

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

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 1400 0
Repatriation General Hospital Daw Park
Ethics committee address [1] 1400 0
Ethics committee country [1] 1400 0
Australia
Date submitted for ethics approval [1] 1400 0
Approval date [1] 1400 0
Ethics approval number [1] 1400 0

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

Contacts
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
Australia
Phone 9435 0
+61 8 82751075
Fax 9435 0
+61 8 82751083
Email 9435 0
alicia.smith@rgh.sa.gov.au
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
Australia
Phone 363 0
+61 8 82751838
Fax 363 0
+61 8 82751083
Email 363 0
scoles.au@rgh.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
No additional documents have been identified.