ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12616001573448

Ethics application status

Approved

Date submitted

7/11/2016

Date registered

14/11/2016

Date last updated

26/02/2019

Date data sharing statement initially provided

20/02/2019

Type of registration

Prospectively registered

Titles & IDs

Public title

The CRISP trial: a risk assessment tool to inform bowel cancer screening in general practice patients

Scientific title

The CRISP Trial: a phase II RCT of a risk assessment and decision support tool for stratified colorectal cancer screening in primary care

Secondary ID [1]

Nil

Universal Trial Number (UTN)

Trial acronym

CRISP

Linked study record

ACTRN12615000155594

Health condition

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

Colorectal Cancer

Condition category

Condition code

Cancer

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

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

The intervention is a web based Colorectal cancer RISk Prediction tool (CRISP) risk assessment tool utilising a risk model to provide patients with a personalised risk assessment and colorectal cancer screening advice based on their risk.
Patients in the intervention group will be invited to complete the risk tool with a trained researcher prior to a consultation with their GP. The tool will take a maximum of 7 minutes and will be completed at baseline only. Participants will receive their risk of colorectal cancer and screening advice based on their risk which they will take with them into their consultation with their GP. All participants will also complete a survey collecting information about cancer risk perception, worry and bowel cancer screening intention and behaviour at baseline, 1 month, 6 months and 12 months after recruitment. The follow up survey should take no more than 15 minutes to complete and will be sent through the post or a link to the online survey will be sent via email.
We will ask for permission to access GP records, records from Medicare, Victorian Admissions and Emergency Dataset (VAED) and from the National Bowel Screening Program (NBCSP) 1, 3 and 5 years after the participants enrol to track the colorectal cancer screening they have had.

Intervention code [1]

Early detection / Screening

Comparator / control treatment

'Usual care' in a primary care clinic as well as general information about 'How to Cut Your Cancer Risk' from the Cancer Council of Victoria. 'Usual care' indicates screening for colorectal cancer will be based on the NHMRC guidelines for colorectal cancer screening. Control patients will be having a consultation without being provided with absolute risk of colorectal cancer.

Control group

Active

Outcomes

Primary outcome [1]

The primary outcome will be the proportion of participants who have had risk-appropriate screening after 12 months' follow-up. Appropriateness of screening will be determined by their absolute 5-year risk of CRC, using a 1% threshold and completion of FOBT, colonoscopy no screening, or a referral to a Familial Cancer Centre for genetic counselling if indicated by their family history. Patient self-report at 12 months will tell us what screening each patient has had and this will be cross-checked with GP records, records from Medicare, Victorian Admissions and Emergency Dataset (VAED) and from the National Bowel Screening Program (NBCSP)

Timepoint [1]

12 months post recruitment

Secondary outcome [1]

Proportion of participants who have had risk-appropriate screening after 5 years' follow-up, measured as above for primary endpoint. We will ask for permission to access GP records, records from Medicare, Victorian Admissions and Emergency Dataset (VAED) and from the National Bowel Screening Program (NBCSP) to determine screening undertaken at 5 years.

Timepoint [1]

5 years post recruitment

Secondary outcome [2]

Risk perception: personal perceived risk, absolute and comparative, will be measured using an existing validated tool - the 'Family History Questionnaire'.

Timepoint [2]

Baseline, 1 month, 6 months and 12 months after recruitment

Secondary outcome [3]

Cancer worry using the Cancer Worry Scale

Timepoint [3]

Baseline, 1 month, 6 months and 12 months after recruitment

Secondary outcome [4]

Intentions to have FOBT and/or colonoscopy in the next three months based on items from the Theory of Planned Behaviour

Timepoint [4]

Baseline, 1 month, 6 months and 12 months

Secondary outcome [5]

Clinical outcomes of screening tests, obtained from GP records including detection of pre-malignancies and colorectal cancer lesions

Timepoint [5]

Baseline, 1 month, 6 months, 12 months, 5 years after recruitment

Secondary outcome [6]

Health service utilisation and health care costs. We will measure GP consultations, referrals for colonoscopy, and completion of FOBT. Costs of delivering the CRISP and control consultations will be calculated.
This includes assessment of GP consultations, colonoscopy services, FOBT and associated pathology services. Costs of delivering the CRISP and control consultations will also be calculated. Any other associated changes in health care utilisation will be captured through access to patients Medicare data.

Timepoint [6]

12 months post recruitment

Eligibility

Key inclusion criteria

Primary care patients between 50 and 74 years old who have an appointment with their general practitioner (GP). This applies only to patients of consenting GPs who have been recruited into the trial.

Minimum age

50 Years

Maximum age

74 Years

Sex

Both males and females

Can healthy volunteers participate?

Yes

Key exclusion criteria

Anyone who has had a previous cancer diagnosis, has symptoms of colorectal cancer, is already having surveillance for bowel disease, or is not competent to consent in English will be excluded from being in the trial.

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)

Yes, central randomisation by computer will be employed after enrolment

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation)

Masking / blinding

Open (masking not used)

Who is / are masked / blinded?

Intervention assignment

Parallel

Other design features

Phase

Not Applicable

Type of endpoint/s

Efficacy

Statistical methods / analysis

The primary analysis will be a comparison between groups on the proportion of participants who have had appropriate CRC screening at 12 months using logistic regression with the randomisation stratification factor, general practice, as a covariate. The health economic analyses will combine a within trial and modelled analysis of the cost-effectiveness of implementing the CRISP tool.

Recruitment

Recruitment status

Active, not recruiting

Date of first participant enrolment

Anticipated

1/03/2017

Actual

9/05/2017

Date of last participant enrolment

Anticipated

Actual

4/05/2018

Date of last data collection

Anticipated

4/05/2023

Actual

Sample size

Target

732

Accrual to date

Final

732

Recruitment in Australia

Recruitment state(s)

VIC

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

National Health and Medical Research Council

Address [1]

National Health and Medical Research Council
GPO Box 1421
Canberra ACT 2601

Country [1]

Australia

Funding source category [2]

Government body

Name [2]

Victorian Cancer Agency

Address [2]

GPO Box 4057 (Level 15)
MELBOURNE VIC 3001

Country [2]

Australia

Primary sponsor type

University

Name

University of Melbourne

Address

200 Berkeley Street
Carlton VIC 3053

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

University of Melbourne Human Ethics Committee

Ethics committee address [1]

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

28/10/2016

Approval date [1]

16/12/2016

Ethics approval number [1]

1647804

Summary

Brief summary

This research is aiming to test an intervention led by the practice nurse in general practice to calculate and discuss people's individual risk of bowel cancer and screening tests in order to have risk appropriate screening to detect a malignancy or pre-malignancy as early as possible.
Who is it for? Any primary care patient aged between 50 and 74 years who has an appointment with a general practitioner (GP) who is participating in the study. Anyone who has had a previous colorectal cancer diagnosis will not be eligible.
Study details: Participants in this study will be randomly (by chance) allocated to one of two groups. Participants in one group will continue to receive the usual care in the primary care clinic. Participants in the other group will go through a web-based colorectal cancer risk assessment with the research nurse, who will then provide risk output and screening advice which can be discussed with their GP. Our primary aim is to determine well the risk assessment tool encourages patients to have and doctors to recommend colorectal cancer screening that is appropriate for the patient’s actual risk of developing the disease. The research is part of a larger body of research: the 'NHMRC Centre for Research Excellence for Reducing the Burden of Colorectal Cancer by Optimising Screening: Evidence to Clinical Practice'.

Trial website

Trial related presentations / publications

Walker, J. G., Macrae, F., Winship, I., Oberoi, J., Saya, S., Milton, S., ... & Galloway, L. (2018). The use of a risk assessment and decision support tool (CRISP) compared with usual care in general practice to increase risk-stratified colorectal cancer screening: study protocol for a randomised controlled trial. Trials, 19(1), 397.
Emery, J. D., Pirotta, M., Macrae, F., Walker, J. G., Qama, A., Boussioutas, A., & Jenkins, M. (2018). 'Why don't I need a colonoscopy?': A novel approach to communicating risks and benefits of colorectal cancer screening. Australian Journal of General Practice, 47(6), 343

Public notes

Contacts

Principal investigator

Name

Prof Jon Emery

Address

Centre for Cancer Research
Department of General Practice
Faculty of Medicine, Dentistry and Health Sciences
Level 10, 305 Grattan St,
Victorian Comprehensive Cancer Centre
University of Melbourne 3010

Country

Australia

Phone

+61385597044

Fax

jon.emery@unimelb.edu.au

Contact person for public queries

Name

Jennifer G Walker

Address

Country

Australia

Phone

+61385597048

Fax

walker@unimelb.edu.au

Contact person for scientific queries

Name

Jon Emery

Address

Country

Australia

Phone

+61385597044

Fax

jon.emery@unimelb.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	Other Details	Attachment
1411	Study protocol	Walker, J. G., Macrae, F., Winship, I., Oberoi, J.... [More Details]
1412	Ethical approval		371743-(Uploaded-20-02-2019-10-45-12)-Study-related document.pdf
1413	Informed consent form		371743-(Uploaded-20-02-2019-10-48-34)-Study-related document.pdf

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
Embase	The use of a risk assessment and decision support tool (CRISP) compared with usual care in general practice to increase risk-stratified colorectal cancer screening: Study protocol for a randomised controlled trial.	2018	https://dx.doi.org/10.1186/s13063-018-2764-7
Embase	The Colorectal cancer RISk Prediction (CRISP) trial: a randomised controlled trial of a decision support tool for risk-stratified colorectal cancer screening.	2023	https://dx.doi.org/10.3399/BJGP.2022.0480

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

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