Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000095066
Ethics application status
Approved
Date submitted
20/01/2010
Date registered
28/01/2010
Date last updated
11/07/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
Population testing of an internet-based Personalised Decision Support system for Colorectal Cancer screening
Scientific title
Population testing of an internet-based Personalised Decision Support system aimed at improving participation in Colorectal Cancer screening in persons considered at risk of developing Colorectal Cancer (CRC)
Secondary ID [1] 1336 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Colorectal/Bowel Cancer 256611 0
Condition category
Condition code
Cancer 256777 256777 0 0
Bowel - Back passage (rectum) or large bowel (colon)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants in the intervention conditions receive ONE of ethier an internet-based tailored decision support intervention, or internet-based non-tailored decision support intervention. In each intervention, participants answer questions concerning their perceived susceptibility to Colorectal cancer (CRC) and attitudes towards CRC screening. Tailored responses are then generated for the 'tailored group' which are designed to correct misaprehensions where they exist. For the non-tailored group participants do not receive tailored messages but rather generic information brochures concerning Colorectal cancer. This intervention is accessed once only and participants work through it at their own pace. The overall duration of the study will be approximately 12 months.
Intervention code [1] 255869 0
Behaviour
Comparator / control treatment
Group 3 will act as the control arm of the study and participants will receive no intervention
Control group
Active

Outcomes
Primary outcome [1] 257651 0
Number of participants completing a colorectal cancer screening test per group. All participants receive a free Colorectal Cancer screening test and the number of kits returned per study arm is recorded upon return of the kit
Timepoint [1] 257651 0
approximately one year after randomisation
Secondary outcome [1] 262928 0
Usability of the decision tool. This will be assessed by phone interview at the conclusion of the study. Participants will be asked about how well they thought the decision tool operated and will be asked to identify issues which they thought were difficult etc.
Timepoint [1] 262928 0
approximately one year after randomisation

Eligibility
Key inclusion criteria
Access to Internet at some location,
Have not screened for Colorectal Cancer within the preceding 12 months
Minimum age
50 Years
Maximum age
74 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Presence of Colorectal cancer or other bowel disease,
Active participation in other ongoing screening programs

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
1/03/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
5400
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,VIC,QLD,SA,WA,TAS

Funding & Sponsors
Funding source category [1] 256354 0
Government body
Name [1] 256354 0
National Health and Medical Research Council
Country [1] 256354 0
Australia
Primary sponsor type
Government body
Name
Commonwealth Scientific and Industrial Research Organisation (CSIRO) Preventative Health Flagship
Address
Kintore Avenue
Adelaide SA 5001
Country
Australia
Secondary sponsor category [1] 251674 0
Other Collaborative groups
Name [1] 251674 0
Adelaide Colorectal Cancer Collaborative
Address [1] 251674 0
Adelaide Colorectal Cancer Collaborative
C/O Ms Ingrid Flight
CSIRO Food and Nutritional Sciences
PO Box 10041
Adelaide BC SA 5000
Country [1] 251674 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 258428 0
CSIRO Food and Nutritional Sciences Human Research Ethics Committee (HREC)
Ethics committee address [1] 258428 0
POBox 10041
Adelaide BC, SA 5000
Ethics committee country [1] 258428 0
Australia
Date submitted for ethics approval [1] 258428 0
Approval date [1] 258428 0
17/12/2009
Ethics approval number [1] 258428 0
#09/33

Summary
Brief summary
The purpose of this study is to investigate the effect of utilisation of an internet-based personalised decision support (PDS) tool on screening behaviour for Colorectal Cancer. Our hypothesis is that individuals who are provided access to the PDS will be more likely to participate in screening than those who are not provided access. The study fits in with the aim of improving participation in CRC screening nationally, and if effective the PDS can be implemented on a large scale; for instance, as part of the Department of Health and Ageing's national screening program.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 30735 0
Address 30735 0
Country 30735 0
Phone 30735 0
Fax 30735 0
Email 30735 0
Contact person for public queries
Name 13982 0
Mr Ian Zajac
Address 13982 0
CSIRO Human Nutrition
PO Box 10041
Kintore Avenue
Adelaide, SA 5000
Country 13982 0
Australia
Phone 13982 0
+61 8 8303 8875
Fax 13982 0
+61 8 8303 8899
Email 13982 0
[email protected]
Contact person for scientific queries
Name 4910 0
Professor Carlene Wilson
Address 4910 0
202 Greenhill Rd
Eastwood SA 5063
Country 4910 0
Australia
Phone 4910 0
+61 8 8291 4345
Fax 4910 0
Email 4910 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.