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
ACTRN12607000395437
Ethics application status
Approved
Date submitted
19/07/2007
Date registered
1/08/2007
Date last updated
1/08/2007
Type of registration
Retrospectively registered

Titles & IDs
Public title
Presentation of preventive health information: a comparison of paper versus computer
Scientific title
Population-based cancer screening: Distinguishing the influence of tailoring content and presentation via the web, compared to paper-based material, on knowledge of and attitudes to colorectal cancer screening
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Colorectal cancer screening 2186 0
Condition category
Condition code
Cancer 2282 2282 0 0
Bowel - Back passage (rectum) or large bowel (colon)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Baseline survey (measuring attitudes to screening and readiness to engage in screening) followed by endpoint survey approximately 2 weeks later for all intervention groups and control group. Separate interventions will occur immediately before administration of the endpoint survey: non-personalised paper-based colorectal cancer (CRC) screening information; personalised paper-based CRC screening information; non-personalised web-based CRC screening information; personalised web-based CRC screening information; baseline and endpoint survey only (control). Those individuals who, in the endpoint survey, indicate they are ready to screen will be provided with a FOBT (faecal occult blood test) kit. Those that indicate that they are not ready to screen will be provided with a "request for kit" card to return within one year of the intervention.
Intervention code [1] 1895 0
Behaviour
Comparator / control treatment
Control group
Active

Outcomes
Primary outcome [1] 3173 0
Change in screening decision stage.
Timepoint [1] 3173 0
Measured at the endpoint survey.
Secondary outcome [1] 5290 0
For the intervention groups, intention to screen and tracking of decision making processes will be measured immediately following the intervention (ie as part of the intervention). Actual uptake of screening will be measured for intervention and control groups at 35 days from provision of the FOBT kit. Tracking of decision processes will not be an outcome for the control group.
Timepoint [1] 5290 0

Eligibility
Key inclusion criteria
Some familiarity with using a computer to search the Internet.
Minimum age
50 Years
Maximum age
76 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Current regular CRC screening; diagnosis of colorectal cancer or polyps.

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)
Participants will be a random sample within certain electoral areas, provided by the Australian Electoral Commission. Names will again be randomised and then divided into 5 groups by a researcher not working on the study
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Each of the 5 groups will be randomly assigned to one of four intervention groups or to control groups using computer-generated random number sequence. This will be performed by a researcher not involved with the study
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
30/07/2007
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
125
Accrual to date
Final

Funding & Sponsors
Funding source category [1] 2448 0
Government body
Name [1] 2448 0
Commonwealth Scientific and Industrial Research Organisation (CSIRO) Preventative Health Flagship (internal funding)
Country [1] 2448 0
Australia
Primary sponsor type
Government body
Name
CSIRO Preventative Health Flagship
Address
Country
Australia
Secondary sponsor category [1] 2220 0
Other Collaborative groups
Name [1] 2220 0
Adelaide Colorectal Cancer Collaborative
Address [1] 2220 0
Country [1] 2220 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 4302 0
CSIRO Human Nutrition
Ethics committee address [1] 4302 0
Kintore Avenue
Adelaide SA
Ethics committee country [1] 4302 0
Australia
Date submitted for ethics approval [1] 4302 0
Approval date [1] 4302 0
26/09/2007
Ethics approval number [1] 4302 0
06/20

Summary
Brief summary
The primary aim of the study is to investigate whether it is perceived personal relevance (through tailoring of messages to an individual's specific health beliefs concerning colorectal cancer screening), or ease of navigation (through web-based delivery) to access personally relevant material, or both factors, that has the greater effect on the decision to screen for colorectal cancer using a Faecal Occult Blood kit (FOBT). Our hypothesis is that individuals receiving tailored, web-based information are more likely to decide to screen. The study fits in with the broader aim of attempting to understand the factors that motivate people to participate in colorectal cancer screening, and can serve as a basis for providing consumer information and decision tools designed to increase participation in colorectal cancer screening technologies.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 27709 0
Address 27709 0
Country 27709 0
Phone 27709 0
Fax 27709 0
Email 27709 0
Contact person for public queries
Name 11084 0
Ms Ingrid Flight
Address 11084 0
CSIRO Human Nutrition
PO Box 10041
Kintore Avenue
Adelaide SA 5000
Country 11084 0
Australia
Phone 11084 0
(08) 8303 8881
Fax 11084 0
Email 11084 0
[email protected]
Contact person for scientific queries
Name 2012 0
Dr Carlene Wilson
Address 2012 0
CSIRO Human Nutrition
PO Box 10041
Kintore Avenue
Adelaide BC SA 5000
Country 2012 0
Australia
Phone 2012 0
(08) 8303 8906
Fax 2012 0
Email 2012 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.