Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12605000279628
Ethics application status
Approved
Date submitted
1/09/2005
Date registered
2/09/2005
Date last updated
2/09/2005
Type of registration
Retrospectively registered

Titles & IDs
Public title
Interventions to improve participation in bowel cancer screening: the value of lay advocacy and positive framing of risk.
Scientific title
Interventions to improve participation in bowel cancer screening: the value of lay advocacy and positive framing of risk.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Screening for bowel cancer 367 0
Condition category
Condition code
Cancer 430 430 0 0
Bowel - Anal
Cancer 431 431 0 0
Bowel - Back passage (rectum) or large bowel (colon)
Cancer 432 432 0 0
Bowel - Small bowel (duodenum and ileum

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention 1: the use of a bowel cancer screening invitation letter to that contains photographs of 2 previous screenees who were diagnosed with early bowel cancer through their participation in a bowel cancer screening program, and with simple program advocacy statements from them.
Intervention 2: the use of a bowel cancer screening invitation letter that contains enhanced positive framing and generalised risk messages.
Intervention code [1] 330 0
Behaviour
Comparator / control treatment
Control: A generic invitation letter
Control group
Active

Outcomes
Primary outcome [1] 493 0
Completion of faecal immunochemical test within 12 weeks of offer
Timepoint [1] 493 0
Secondary outcome [1] 1058 0
Test positivity rate
Timepoint [1] 1058 0
Secondary outcome [2] 1059 0
Yield of neoplasia
Timepoint [2] 1059 0

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
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
People already participating in bowel cancer screening research and service programs coordinated from the Bowel Health Service, Repatriation 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 one of three screening programs differing in intvitation content. Allocation to invitation group is not concealed from the investigators and office staff who print and package invitation kits for postal delivery, but there is no direct contact netween investigators and invitees. Invitees are unaware that there are more than one invitation type. A help line is available and inquiries are answered without knowledge of invitation type.
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 1 (Lay advocacy), the second 600 to Intervention group 2 (risk framing) and the third 600 to the 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
1800
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 482 0
Government body
Name [1] 482 0
NHMRC project grant 187644
Country [1] 482 0
Australia
Primary sponsor type
Individual
Name
Prof. Graeme Young MD, FRACP
Address
Country
Secondary sponsor category [1] 389 0
Individual
Name [1] 389 0
Mr Stephen Cole
Address [1] 389 0
Country [1] 389 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 1461 0
Repatriation General Hospital Daw Park
Ethics committee address [1] 1461 0
Daws Rd, Daw Park, SA 5041
Ethics committee country [1] 1461 0
Australia
Date submitted for ethics approval [1] 1461 0
Approval date [1] 1461 0
Ethics approval number [1] 1461 0

Summary
Brief summary
Improved participation in screening for bowel cancer is desirable. Currently population scale bowel cancer screening program delivery is by mailed offer from a central screening service and invitations include a faecal occult blood detection kit. Invitees may decline the offer because they do not feel they are at risk, or because they do not engage with the program. We have developed invitation letters to that include either improved risk messages or messages from previous screening participants in order to overcome these barriers.
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

Contacts
Principal investigator
Name 36228 0
Address 36228 0
Country 36228 0
Phone 36228 0
Fax 36228 0
Email 36228 0
Contact person for public queries
Name 9519 0
Ms Alicia Smith
Address 9519 0
Bowel Health Service
Repatriation General Hospital Daw Park
Daws Rd
Daw Park SA 5041
Country 9519 0
Australia
Phone 9519 0
+61 8 82751075
Fax 9519 0
Email 9519 0
[email protected]
Contact person for scientific queries
Name 447 0
Mr Stephen Cole
Address 447 0
Bowel Health Service
Repatriation General Hospital Daw Park
Daws Road
Daw Park SA 5041
Country 447 0
Australia
Phone 447 0
+61 8 82751838
Fax 447 0
+61 8 82751083
Email 447 0
[email protected]

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.