Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12607000147482
Ethics application status
Approved
Date submitted
12/09/2005
Date registered
27/02/2007
Date last updated
27/02/2007
Type of registration
Retrospectively registered

Titles & IDs
Public title
Investigation of the effects of cues to action on participation in colorectal (CRC) screening - the role of implementation intentions
Scientific title
Population-based colorectal cancer screening - does the provision of cues to action, compared to no provision, lead to increased rates of faecal occult blood test kit completion?
Universal Trial Number (UTN)
Trial acronym
Cues to Action
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Colorectal carcinoma (CRC) 1641 0
Condition category
Condition code
Cancer 1751 1751 0 0
Bowel - Back passage (rectum) or large bowel (colon)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Fecal Immunochemical Tests (FIT) will be mailed to participants. An implementation plan will be included for the 3 intervention groups. The implementation plans provided serve as 'cues to action' to provide a plan for goal achievement. Two intervention groups will receive an implementation plan that asks participants to think about, for example, how they will remember to do the test and to write down how they will remind themselves. One group will send a copy of this plan back to CSIRO, the other group will retain the plan. The 'prescriptive' implementation plan will 'tell' participants how to act, eg "place a reminder in a prominent place so that you do not forget to use the kit".

Intervention 1: FIT kit + implementation plan to complete and retain. Receipt of completed kit by Bowel Health Service (BHS) within 35 days
Intervention 2: FIT kit + implementation plan to complete and return to CSIRO. Receipt of completed kit by Bowel Health Service (BHS) within 35 days
Intervention 3: FIT kit + prescriptive implementation plan to complete and return to CSIRO. Receipt of completed kit by Bowel Health Service (BHS) within 35 days
Intervention code [1] 495 0
Behaviour
Comparator / control treatment
Control: FIT kit only. Receipt of completed kit by Bowel Health Service (BHS) within 35 days
Control group
Active

Outcomes
Primary outcome [1] 2440 0
Return of completed FIT kit
Timepoint [1] 2440 0
Within 35 days of receipt by participant
Secondary outcome [1] 4211 0
Self efficacy: Receipt of completed questionnaire by CSIRO (BHS) within 35 days of receipt by participant. The effects of increasing levels of directedness in the formation of behaviour intentions (individually specified plan for behaviour versus behaviour plan specified by the researcher).
Timepoint [1] 4211 0
Receipt of completed kit by Bowel Health Service (BHS) within 35 days.

Eligibility
Key inclusion criteria
Never diagnosed with polyps or colorectal cancer.
Minimum age
50 Years
Maximum age
76 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Current participation in regular program of screening for CRC, those whose address indicates that they reside in a nursing home.

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)
Allocation to intervention was performed by central randomisation by computer prior to the participant being approached. The recruiting interviewer was unaware of an individual's allocation until they reached that part of the computer-assisted interview which provided details of the particular intervention which the participant (after having been determined for eligibility) could expect.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The sample was stratified by gender. Thereafter, simple randomisation by using a randomisation table created by a computer software (i.e., computerised sequence generation) was used for allocation to intervention group.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Participants will be unaware of other types of interventions being trialled, apart from what they are being asked to do.
Phase
Phase 1
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
6/07/2004
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
3200
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1902 0
Government body
Name [1] 1902 0
Commonwealth Scientific and Industrial Organisation (CSIRO) Preventative Health Flagship
Country [1] 1902 0
Australia
Primary sponsor type
Government body
Name
Commonwealth Scientific and Industrial Research Organisation (CSIRO) Preventative Health Flagship
Address
Country
Australia
Secondary sponsor category [1] 1717 0
None
Name [1] 1717 0
Nil
Address [1] 1717 0
Country [1] 1717 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 3548 0
CSIRO Human Nutrition
Ethics committee address [1] 3548 0
Ethics committee country [1] 3548 0
Australia
Date submitted for ethics approval [1] 3548 0
Approval date [1] 3548 0
16/03/2005
Ethics approval number [1] 3548 0
04/02

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

Contacts
Principal investigator
Name 35297 0
Address 35297 0
Country 35297 0
Phone 35297 0
Fax 35297 0
Email 35297 0
Contact person for public queries
Name 9684 0
Ingrid Flight
Address 9684 0
Commonwealth Scientific and Industrial Research Organisation (CSIRO)
Human Nutrition
PO Box 10041
Adelaide BC SA 5000
Country 9684 0
Australia
Phone 9684 0
+61 8 83038881
Fax 9684 0
+61 8 83038899
Email 9684 0
ingrid.flight@csiro.au
Contact person for scientific queries
Name 612 0
Dr Carlene Wilson
Address 612 0
Commonwealth Scientific and Industrial Research Organisation (CSIRO)
Human Nutrition
PO Box 10041
Adelaide BC SA 5000
Country 612 0
Australia
Phone 612 0
+61 8 830338906
Fax 612 0
+61 8 83038899
Email 612 0
carlene.wilson@csiro.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.