ANZCTR - Registration

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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]

nil

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Bowel (Colorectal) Cancer

Condition category

Condition code

Cancer

Bowel - Back passage (rectum) or large bowel (colon)

Public Health

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]

Early detection / Screening

Intervention code [2]

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]

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]

12 to 18 months after randomisation, t=1

Primary outcome [2]

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]

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]

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]

12 to 18 months after randomisation, t=1.

Secondary outcome [2]

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]

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]

Government body

Name [1]

Cancer Australia

Address [1]

Postal address: PO Box 1201, DICKSON ACT 2602

Country [1]

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]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Human Research Ethics Committee at the University of Sydney

Ethics committee address [1]

Research Integrity and Ethics Administration
Level 3, Administration Building (F23)
University of Sydney
NSW 2006

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

19/08/2011

Approval date [1]

10/10/2011

Ethics approval number [1]

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

Prof Lyndal Trevena

Address

Room 121a, Edward Ford Building (A27)
The University of Sydney NSW 2006

Country

Australia

Phone

+61 293517788

Fax

lyndal.trevena@sydney.edu.au

Contact person for public queries

Name

Professor Lyndal Trevena

Address

School of Public Health
Sydney Medical School
Rm 125, Lvl 1, Edward Ford Building A27
The University of Sydney
NSW 2006

Country

Australia

Phone

+61 2 96367699

Fax

angela.obrien@sydney.edu.au

Contact person for scientific queries

Name

Professor Lyndal Trevena

Address

Rom 121A Edward Ford Building (A27) University of Sydney NSW 2006

Country

Australia

Phone

+61 2 9351 7788

Fax

lyndal.trevena@sydney.edu.au

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

No/undecided IPD sharing reason/comment

What supporting documents are/will be available?

Doc. No.	Type	Email
13857	Study protocol	lyndal.trevena@sydney.edu.au
13858	Informed consent form	lyndal.trevena@sydney.edu.au
13859	Ethical approval	lyndal.trevena@sydney.edu.au

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

Source	Title	Year of Publication	DOI
Dimensions AI	Which Test Is Best? A Cluster-Randomized Controlled Trial of a Risk Calculator and Recommendations on Colorectal Cancer Screening Behaviour in General Practice	2022	https://doi.org/10.1159/000526628

N.B. These documents automatically identified may not have been verified by the study sponsor.

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Documents added manually

Documents added automatically