Trial Review

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
ACTRN12607000461493
Ethics application status
Approved
Date submitted
28/08/2007
Date registered
12/09/2007
Date last updated
12/09/2007
Type of registration
Prospectively registered

Titles & IDs
Public title
Reducing barriers to colorectal cancer screening: The impact of enhanced advance notification letters.
Scientific title
Improving participation in bowel cancer screening through the use of enhanced advance notification letters
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Bowel cancer. 2302 0
Condition category
Condition code
Cancer 2399 2399 0 0
Bowel - Back passage (rectum) or large bowel (colon)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Two alternative advance notification strategies will be trialed. Intervention 1 will consist of a simple 'advance notification of an invitation to participate in screening for Colorectal Carcinoma (CRC)' letter incorporating messages introducing the concept of screening for CRC, increased risk for CRC and the value of screening to reduce risk. Intervention 2 (enhanced advance notification) will include those messages plus more complex messages to reduce known barriers (lack of knowledge about CRC and its prevention, aversion for faecal sampling, low perception of the value of Fecal Occult Blood Test (FOBT) screening). The advance notification letters will be followed in 2 weeks by a standard invitation-to-screen letter. A control group will receive the standard invitation only. Invitees have 12 weeks from date of invitation-to-screen in which to participate in screening.
Intervention code [1] 2020 0
Behaviour
Comparator / control treatment
An invitation to screening without prior advance notification.
Control group
Active

Outcomes
Primary outcome [1] 3301 0
Completion of faecal immunochemical test expressed as the population participation rate.
Timepoint [1] 3301 0
Within 12 weeks of screening invitation.
Secondary outcome [1] 5498 0
Test positivity rate.
Timepoint [1] 5498 0
Within 12 weeks of screening offer.

Eligibility
Key inclusion criteria
Present on the electoral roll of the Australian Electoral Commission, and living in specified post code.
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 screening research and service programs, people who have medical conditions that invalidate screening test results or preclude them from colonoscopy, all people who have had an faecal occult blood 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 randomly selected by computer from an extract of the Australian electoral roll are randomly allocated by a computer to a screening program with a preliminary notification letter (2 types) or without notification letter. 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 is a significant program improvement. All eligible people were assigned a random number using the MS Excel RAND function. The listing was ordered by ascending random number. The first 600 were assigned to intervention group 1 (enhanced advance notification), the second to intervention group 2 (standard advance notification), the third to control (no advance notification).
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
Not yet recruiting
Date of first participant enrolment
Anticipated
17/09/2007
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)
Recruitment postcode(s) [1] 237 0
5007
Recruitment postcode(s) [2] 238 0
5009
Recruitment postcode(s) [3] 239 0
5022
Recruitment postcode(s) [4] 240 0
5024
Recruitment postcode(s) [5] 241 0
5025
Recruitment postcode(s) [6] 242 0
5031
Recruitment postcode(s) [7] 243 0
5032
Recruitment postcode(s) [8] 244 0
5033
Recruitment postcode(s) [9] 245 0
5037
Recruitment postcode(s) [10] 246 0
5038
Recruitment postcode(s) [11] 247 0
5039
Recruitment postcode(s) [12] 248 0
5040
Recruitment postcode(s) [13] 249 0
5043
Recruitment postcode(s) [14] 250 0
5044
Recruitment postcode(s) [15] 406 0
5045
Recruitment postcode(s) [16] 407 0
5041
Recruitment postcode(s) [17] 408 0
5042
Recruitment postcode(s) [18] 409 0
5046
Recruitment postcode(s) [19] 410 0
5047
Recruitment postcode(s) [20] 411 0
5048
Recruitment postcode(s) [21] 412 0
5049
Recruitment postcode(s) [22] 413 0
5050
Recruitment postcode(s) [23] 414 0
5051
Recruitment postcode(s) [24] 415 0
5052
Recruitment postcode(s) [25] 416 0
5062
Recruitment postcode(s) [26] 417 0
5064
Recruitment postcode(s) [27] 418 0
5156
Recruitment postcode(s) [28] 419 0
5159

Funding & Sponsors
Funding source category [1] 2558 0
Government body
Name [1] 2558 0
National Health and Medical Research Council (NHMRC)
Country [1] 2558 0
Australia
Primary sponsor type
University
Name
Flinders University
Address
Bedford Park SA 5042
Country
Australia
Secondary sponsor category [1] 2318 0
Hospital
Name [1] 2318 0
Repatriation General Hospital Daw Park
Address [1] 2318 0
Daws Rd
Daw Park SA 5041
Country [1] 2318 0
Australia
Secondary sponsor category [2] 2319 0
None
Name [2] 2319 0
Address [2] 2319 0
Country [2] 2319 0
Other collaborator category [1] 19 0
University
Name [1] 19 0
University of Adelaide
Address [1] 19 0
Adelaide SA 5000
Country [1] 19 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 4485 0
Research and Ethics Committee, Repatriation General Hospital
Ethics committee address [1] 4485 0
Daws Rd
Daw Park SA 5041
Ethics committee country [1] 4485 0
Australia
Date submitted for ethics approval [1] 4485 0
Approval date [1] 4485 0
20/06/2007
Ethics approval number [1] 4485 0
39/07

Summary
Brief summary
Previous research has demonstrated that the use of a simple advance notification letter preceding an invitation to participate in bowel cancer screening resulted in a significant increase in population participation compared to no advance notification of invitation. This study further explores the value of advance notification by comparing screening participation between 3 groups: 1) using an enhanced version specifically addressing known barriers (aversion for collecting faecal samples, lack of knowledge about bowel cancer, low perception of the value of screening); 2) a simple advance notification letter and 3) a control group not receiving advance notification.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28010 0
Address 28010 0
Country 28010 0
Phone 28010 0
Fax 28010 0
Email 28010 0
Contact person for public queries
Name 11167 0
Stephen Cole
Address 11167 0
Bowel Health Service
Repartiation General Hospital
Daws Rd
Daw Park SA 5041
Country 11167 0
Australia
Phone 11167 0
+61 8 82751083
Fax 11167 0
Email 11167 0
[email protected]
Contact person for scientific queries
Name 2095 0
Stephen Cole
Address 2095 0
Bowel Health Service
Repartiation General Hospital
Daws Rd
Daw Park SA 5041
Country 2095 0
Australia
Phone 2095 0
+61 8 82751083
Fax 2095 0
Email 2095 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.