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Trial registered on ANZCTR


Registration number
ACTRN12615000155594
Ethics application status
Approved
Date submitted
28/01/2015
Date registered
17/02/2015
Date last updated
5/01/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
The CRISP (Colorectal cancer RISk Prediction tool) trial: providing personalised advice about bowel cancer screening in primary care..
Scientific title
The CRISP study: trialing the use of a web-based colorectal cancer risk assessment tool with primary care patients as a 'nurse-led' intervention to determine the feasibility of using the method for a larger trial.
Secondary ID [1] 286059 0
nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
colorectal cancer 294043 0
Condition category
Condition code
Cancer 294345 294345 0 0
Bowel - Small bowel (duodenum and ileum)
Cancer 294346 294346 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 paper based 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.
Intervention code [1] 291047 0
Early detection / Screening
Comparator / control treatment
'Usual care' in a primary care clinic as well as general information about 'How to Cut Cancer Risk' from the Cancer Council of Victoria. 'Usual care' implies 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] 294147 0
The primary outcome will be the feasibility of conducting the research using the method in primary care in particular recruiting methods. The study will analysed using qualitative methods including thematic analysis.
Timepoint [1] 294147 0
Baseline, 1 month, 6 months and 12 months after recruitment
Secondary outcome [1] 312614 0
Associations will be explored with outcomes and demographics and clinical variables including age, gender, marital status, postcode, highest education level, family history from questionnaire data.
Timepoint [1] 312614 0
Baseline and 12 months
Secondary outcome [2] 312795 0
Risk perception: personal perceived risk, absolute and comparative, will be measured using an existing validated tool - the 'Family History Questionnaire'.
Timepoint [2] 312795 0
Baseline, 1 month, 6 months and 12 months after recruitment
Secondary outcome [3] 312796 0
Cancer worry using a modified version of the Breast Cancer Worry scale.
Timepoint [3] 312796 0
baseline, 1 month, 6 months and 12 months after recruitment
Secondary outcome [4] 312797 0
Intentions to have FOBT and/or colonoscopy in the next three months based on items from the Theory of Planned Behaviour.
Timepoint [4] 312797 0
Baseline, 1 month, 6 months and 12 months
Secondary outcome [5] 312798 0
The proportion of participants who have had risk-appropriate screening for colorectal cancer after 12 months follow-up. Risk-appropriate screening will be determined by current NHMRC colorectal cancer screening guidelines. Data will include patient self-report and results of faecal occult blood testing and colonoscopy from GP records, Medicare, the National Bowel Cancer Screening Program and the Victorian Admitted Episodes Data (VAED).
Timepoint [5] 312798 0
12 months after recruitment
Secondary outcome [6] 312799 0
Clinical outcomes of screening tests, obtained from GP records including detection of pre-malignancies and colorectal cancer lesions.
Timepoint [6] 312799 0
Baseline, 1 month, 6 months, 12 months after recruitment
Secondary outcome [7] 312800 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 [7] 312800 0
12 months

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 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)
Primary care patients between 50 and 75 years old waiting to attend an appointment with their GP will be approached by a trained research assistant who will check their age and invite them to discuss a trial. The RA will take interested patients to a research fellow/nurse in a private room who will determine eligibility and then follow the informed consent protocol if they are interested and eligible patients. Once consented, the researcher will randomise the patient and then if in the intervention group, the researcher will go through the risk tool (CRISP) with the patient, and provide risk output and screening advice which they will pass on to their GP. If in the control group, the patient will not discuss bowel cancer screening. Both groups will be given questionnaires and information about general cancer prevention.
Detailed information including recruitment rate and feasibility issues will be recorded by the two researchers who will be recruiting.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The randomisation sequence has been generated by a statistician and unknown by the researcher. The sequence generated is either 'A' or 'B'. Following the generated sequence in order, either an 'A' or a 'B' on a folded piece of paper has been placed in non see-through envelopes which have then been numbered on the outside from 1 to 110. This has been completed by another researcher (not conducting the randomisation). The researcher doing the consenting and randomisation will assign 'A' or 'B' as 'intervention' or 'control' by flipping a coin at the beginning of the trial, then inform the statistician which is which. Both recruiting researchers will be blinded to the contents of the envelopes until a participant consents and then the researcher will email the participant number and 'A' or 'B' to the statistician so they can keep an independent record.
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 analysis at this stage will be principally to determine feasibility and will be qualitative. Secondary outcomes will be analysed to determine any differences between intervention and control patients over time.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/10/2015
Actual
13/10/2015
Date of last participant enrolment
Anticipated
18/12/2015
Actual
15/12/2015
Date of last data collection
Anticipated
Actual
3/01/2017
Sample size
Target
100
Accrual to date
Final
85
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment postcode(s) [1] 9182 0
3047 - Broadmeadows
Recruitment postcode(s) [2] 12583 0
3123 - Hawthorn East

Funding & Sponsors
Funding source category [1] 290645 0
Government body
Name [1] 290645 0
National Health and Medical Research Council
Country [1] 290645 0
Australia
Primary sponsor type
University
Name
University of Melbourne
Address
Level 10, 305 Grattan Street, University of Melbourne 3010
Country
Australia
Secondary sponsor category [1] 289338 0
None
Name [1] 289338 0
Address [1] 289338 0
Country [1] 289338 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292277 0
Health Sciences Human Ethics Sub-Committee
Ethics committee address [1] 292277 0
Ethics committee country [1] 292277 0
Australia
Date submitted for ethics approval [1] 292277 0
Approval date [1] 292277 0
24/09/2015
Ethics approval number [1] 292277 0
1442924.4

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 54442 0
Dr Jennifer G Walker
Address 54442 0
Level 10, 305 Grattan Street, University of Melbourne 3010
Country 54442 0
Australia
Phone 54442 0
+61385597048
Fax 54442 0
Email 54442 0
[email protected]
Contact person for public queries
Name 54443 0
Jennifer G Walker
Address 54443 0
Level 10, 305 Grattan Street, University of Melbourne 3010
Country 54443 0
Australia
Phone 54443 0
+61385597048
Fax 54443 0
Email 54443 0
[email protected]
Contact person for scientific queries
Name 54444 0
Jon Emery
Address 54444 0
Level 10, 305 Grattan Street, University of Melbourne 3010
Country 54444 0
Australia
Phone 54444 0
+61385597044
Fax 54444 0
Email 54444 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
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