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Trial registered on ANZCTR


Registration number
ACTRN12611000534987
Ethics application status
Approved
Date submitted
4/04/2011
Date registered
24/05/2011
Date last updated
28/10/2021
Date data sharing statement initially provided
28/10/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
What test is best for you? A bowel cancer family history risk website for patients and their GP's.
Scientific title
A Randomised trial of consumer-led familial cancer risk tool & GP triage on risk-appropriate colorectal cancer screening
Secondary ID [1] 259910 0
nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Bowel (Colorectal) Cancer 265519 0
Condition category
Condition code
Cancer 265670 265670 0 0
Bowel - Back passage (rectum) or large bowel (colon)
Public Health 265671 265671 0 0
Epidemiology

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Individuals from intervention General Practices who opt in to the study will be given a password, allowing them to access the ‘Family History Website’ tool. This online tool will collect information about their family history of colorectal cancer and encourage discussion with their relatives so that they can gather accurate information. Upon completion of the questionnaire, individuals will be assigned to a NHMRC designated risk category for developing CRC, which will be accompanied by the appropriate screening recommendations, with a personalised summary of their information. This information will be accessible to their GP via a shared access facility, and participants will be encouraged to discuss their results with their GP within the following consultation. The completion of the family history website and GP consultation thereafter, is known as Assessment 1 at time = 0. Participants will be followed up 12 months after their completion of the ‘Family History Website’, where they will be required to self report their five year screening behaviour; while their GP’s will complete a file audit and a survey about the utility of the ‘Family History Website’ tool in addition to their knowledge about CRC risk and screening guidelines. This will be known as assessment 2 at time =1
Intervention code [1] 264335 0
Early detection / Screening
Intervention code [2] 264338 0
Prevention
Comparator / control treatment
Individuals from control practices will not be contacted or recruited until time =1, 12 months after the intervention group opt in to the study. At time=1, control participants will be recruited and their self report five year screening behaviour will be recorded, along with a GP file audit, their known family history and demographic information such as age, gender and educational attainment. Consequently, screening behaviour will be measured during the same time for both the intervention and control groups. GP’s from control practices will also be surveyed about their knowledge about CRC risk and screening guidelines. Following the reporting of screening behaviour and the GP survey at time=1, the control group and their GP’s will be able to access ‘Family History Website’ tool if they so wish.
Control group
Active

Outcomes
Primary outcome [1] 266449 0
Outcome Aim: Risk appropriate screening uptake as measured by the participants' five year screening behaviour in relation to their colorectal cancer risk category

Five year screening behaviour- All participants will have their five year screening behaviour recorded at time=1 by self report
Timepoint [1] 266449 0
12 to 18 months after randomisation, t=1
Primary outcome [2] 266450 0
Colorectal cancer risk category- Intervention practice participants will receive a CRC risk category after completing the 'Family History Website' tool., at some time within the 12 month time period t=0. However, participants from control practices will asked about their 'known family history' at time=1, and will not be allowed access to the 'Family History Website' tool, until after that information is collected.
Timepoint [2] 266450 0
Within 12 months of the intervention , t=0 for the intervention group and one year after randomisation, t=1 for the control group
Secondary outcome [1] 273799 0
GP audit and survey- The GP audit will serve to validate self reported screening behaviour for both groups. The GP survey will collect valuable primary care feedback regarding the utility of the family history website (intervention group only), and gauge GP's general awareness of family history risks and current screening recommendations. Additionally, practice demographic information and related characteristics will be recorded. This will also serve as a form of continuing education for GP's and they will be eligible to receive QA and CME points for participating in the study.
Timepoint [1] 273799 0
12 to 18 months after randomisation, t=1.
Secondary outcome [2] 273800 0
Participants demographic information- Demographic information from participants will collected from intervention and control participants. This information will include socio-economic (educational attainment and employment status), gender, family size, age and ethnicity status.
Timepoint [2] 273800 0
This will be collected when participants self report their five year screening behaviour 12 to 18 months after randomisation, t=1.

Eligibility
Key inclusion criteria
25-74 year olds living in Australia, who are able to give informed consent and have English language literacy, with no prior diagnosis of colorectal cancer.
Minimum age
25 Years
Maximum age
74 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
- Individuals under 25 or over 74 years of age
- A previous/current diagnosis of colorectal cancer
- No internet access
- Inability to read/or write English at a year 8 level

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)
This is a random clustered trial, and recruitment will be randomised by practice not participants. General Practices will be sent a letter of invitation. If they agree to participate they will be randomly divided between control and intervention practices. Practices will be expected to be involved in the study at some time over a 12 to 18 month period and will be blind to allocation. Participants will receive an invitation of participation in the study, from their GP practice. Intervention practices will be contacted at t=0 to send out letters of invitation and control practices 12 to 18 months later. Allocation is not concealed from the researchers as this will be required for follow- up.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
GP Practices that opt in to the study will be entered into a database and assigned to intervention or controlled group using a random sequence generator.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/09/2011
Actual
1/12/2011
Date of last participant enrolment
Anticipated
Actual
1/04/2014
Date of last data collection
Anticipated
Actual
1/06/2014
Sample size
Target
7360
Accrual to date
Final
1495
Recruitment in Australia
Recruitment state(s)
NSW,VIC

Funding & Sponsors
Funding source category [1] 264798 0
Government body
Name [1] 264798 0
Cancer Australia
Country [1] 264798 0
Australia
Primary sponsor type
University
Name
University of Sydney
Address
The University of Sydney
School of Public Health
Sydney Medical School
Rm 125, Lvl 1, Edward Ford Building A27
NSW 2006
Australia
Country
Australia
Secondary sponsor category [1] 263910 0
None
Name [1] 263910 0
Address [1] 263910 0
Country [1] 263910 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 266772 0
Human Research Ethics Committee at the University of Sydney
Ethics committee address [1] 266772 0
Research Integrity and Ethics Administration
Level 3, Administration Building (F23)
University of Sydney
NSW 2006
Ethics committee country [1] 266772 0
Australia
Date submitted for ethics approval [1] 266772 0
19/08/2011
Approval date [1] 266772 0
10/10/2011
Ethics approval number [1] 266772 0
14105

Summary
Brief summary
The study will evlaute if implementing a web based tool allowing consumers time to gather information about their family history of bowel (colorectal) cancer , (to be used in conjunction with GP triage), will reduce the proportion of average risk people having an unnecessary colonoscopy; while correctly indentifying and appropriately referring at-risk individuals to Familial Cancer Services and/or offering a colonoscopy. It aims to significantly reduce the public burden of bowel cancer by ensuring that the most effective screening can take place.
Trial website
Trial related presentations / publications
S. Naicker, L. Trevena, B. Meiser, A. Goodwin, T. Dobbins, K. Barlow-Stewart, A. O’Brien, J. Emery, M. Pirotta, J. Kirk. “What test is best for you?” - Evaluating a Family History Assessment tool to assist GP triage in appropriately screening for Colorectal Cancer, Primary Healthcare Conference 2011 Abstracts: Posters, Brisbane, QLD (2011).

S. Naicker, L. Trevena, B. Meiser, A. Goodwin, T. Dobbins, K. Barlow-Stewart, , J. Emery, M. Pirotta, J. Kirk , Developing a consumer-led online familial cancer risk in screening for bowel cancer, Emerging Health Policy Research Conference, University of Sydney (2011).

S. Naicker, L. Trevena, B. Meiser, A. Goodwin, T. Dobbins, K. Barlow-Stewart, , J. Emery, M. Pirotta, J. Kirk. A pilot study to evaluate the utility of an online familial risk tool to screen for colorectal cancer. COSA: Annual scientific meeting 2011 Abstracts: posters, Perth, WA (2011).

S. Naicker, L. Trevena, B. Meiser, A. Goodwin, T. Dobbins, K. Barlow-Stewart, , J. Emery, M. Pirotta, J. Kirk. Implementation of a consumer led online familial risk tool to screen for colorectal cancer: Implications and findings, CRN Postgraduate Research Symposium, University of Sydney, (2011).
Public notes

Contacts
Principal investigator
Name 32434 0
Prof Lyndal Trevena
Address 32434 0
Room 121a, Edward Ford Building (A27)
The University of Sydney NSW 2006
Country 32434 0
Australia
Phone 32434 0
+61 293517788
Fax 32434 0
Email 32434 0
[email protected]
Contact person for public queries
Name 15681 0
Professor Lyndal Trevena
Address 15681 0
School of Public Health
Sydney Medical School
Rm 125, Lvl 1, Edward Ford Building A27
The University of Sydney
NSW 2006
Country 15681 0
Australia
Phone 15681 0
+61 2 96367699
Fax 15681 0
Email 15681 0
[email protected]
Contact person for scientific queries
Name 6609 0
Professor Lyndal Trevena
Address 6609 0
Rom 121A Edward Ford Building (A27) University of Sydney NSW 2006
Country 6609 0
Australia
Phone 6609 0
+61 2 9351 7788
Fax 6609 0
Email 6609 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
13857Study protocol  [email protected]
13858Informed consent form  [email protected]
13859Ethical approval  [email protected]



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
Dimensions AIWhich Test Is Best? A Cluster-Randomized Controlled Trial of a Risk Calculator and Recommendations on Colorectal Cancer Screening Behaviour in General Practice2022https://doi.org/10.1159/000526628
N.B. These documents automatically identified may not have been verified by the study sponsor.