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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
Date results information 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] 290424 0
Nil
Universal Trial Number (UTN)
Trial acronym
CRISP
Linked study record
ACTRN12615000155594

Health condition
Health condition(s) or problem(s) studied:
Colorectal Cancer 300765 0
Condition category
Condition code
Cancer 300604 300604 0 0
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] 296257 0
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] 300016 0
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] 300016 0
12 months post recruitment
Secondary outcome [1] 328809 0
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] 328809 0
5 years post recruitment
Secondary outcome [2] 328810 0
Risk perception: personal perceived risk, absolute and comparative, will be measured using an existing validated tool - the 'Family History Questionnaire'.
Timepoint [2] 328810 0
Baseline, 1 month, 6 months and 12 months after recruitment
Secondary outcome [3] 328811 0
Cancer worry using the Cancer Worry Scale
Timepoint [3] 328811 0
Baseline, 1 month, 6 months and 12 months after recruitment
Secondary outcome [4] 328812 0
Intentions to have FOBT and/or colonoscopy in the next three months based on items from the Theory of Planned Behaviour
Timepoint [4] 328812 0
Baseline, 1 month, 6 months and 12 months
Secondary outcome [5] 328997 0
Clinical outcomes of screening tests, obtained from GP records including detection of pre-malignancies and colorectal cancer lesions
Timepoint [5] 328997 0
Baseline, 1 month, 6 months, 12 months, 5 years after recruitment
Secondary outcome [6] 329175 0
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] 329175 0
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
Gender
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
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 294828 0
Government body
Name [1] 294828 0
National Health and Medical Research Council
Address [1] 294828 0
National Health and Medical Research Council
GPO Box 1421
Canberra ACT 2601
Country [1] 294828 0
Australia
Funding source category [2] 294829 0
Government body
Name [2] 294829 0
Victorian Cancer Agency
Address [2] 294829 0
GPO Box 4057 (Level 15)
MELBOURNE VIC 3001
Country [2] 294829 0
Australia
Primary sponsor type
University
Name
University of Melbourne
Address
200 Berkeley Street
Carlton VIC 3053
Country
Australia
Secondary sponsor category [1] 293671 0
None
Name [1] 293671 0
Address [1] 293671 0
Country [1] 293671 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296217 0
University of Melbourne Human Ethics Committee
Ethics committee address [1] 296217 0
Ethics committee country [1] 296217 0
Australia
Date submitted for ethics approval [1] 296217 0
28/10/2016
Approval date [1] 296217 0
16/12/2016
Ethics approval number [1] 296217 0
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 70030 0
Prof Jon Emery
Address 70030 0
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 70030 0
Australia
Phone 70030 0
+61385597044
Fax 70030 0
Email 70030 0
jon.emery@unimelb.edu.au
Contact person for public queries
Name 70031 0
Dr Jennifer G Walker
Address 70031 0
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 70031 0
Australia
Phone 70031 0
+61385597048
Fax 70031 0
Email 70031 0
walker@unimelb.edu.au
Contact person for scientific queries
Name 70032 0
Prof Jon Emery
Address 70032 0
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 70032 0
Australia
Phone 70032 0
+61385597044
Fax 70032 0
Email 70032 0
jon.emery@unimelb.edu.au

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?
Study protocol
Informed consent form
Ethical approval
How or where can supporting documents be obtained?
Type [1] 1411 0
Study protocol
Citation [1] 1411 0
Link [1] 1411 0
Email [1] 1411 0
Other [1] 1411 0
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.
Attachment [1] 1411 0
Type [2] 1412 0
Ethical approval
Citation [2] 1412 0
Link [2] 1412 0
Email [2] 1412 0
Other [2] 1412 0
Type [3] 1413 0
Informed consent form
Citation [3] 1413 0
Link [3] 1413 0
Email [3] 1413 0
Other [3] 1413 0
Summary results
Have study results been published in a peer-reviewed journal?
No
Other publications
Have study results been made publicly available in another format?
No
Results – basic reporting
Results – plain English summary