Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616001299493
Ethics application status
Approved
Date submitted
30/08/2016
Date registered
15/09/2016
Date last updated
29/05/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Improving uptake of colorectal cancer screening among primary care attendees
Scientific title
Testing the efficacy of providing a point-of-care faecal occult blood test, written screening advice and physician endorsement to improve uptake of colorectal cancer screening among primary care attendees.
Secondary ID [1] 289726 0
Nil
Universal Trial Number (UTN)
U1111-1185-6120
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Colorectal cancer 299569 0
Condition category
Condition code
Cancer 299541 299541 0 0
Bowel - Back passage (rectum) or large bowel (colon)
Public Health 300033 300033 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention group will receive a one-off individual intervention delivered in the primary care clinic.
The intervention will involve the following:
In the waiting room, a research assistant will provide intervention participants with an envelope prior to their GP appointment. The envelope will contain: a) a faecal occult blood test kit with: instructions for completion; pathology request form, and: pre-paid postage to mail the kit for analysis.
b) A feedback sheet containing screening recommendations for those at average risk of colorectal cancer (including recommended: age to commence screening; screening test; frequency of testing). The sheet will also include methods to obtain FOBT as well as what to do with the FOBT provided.

The research assistant will deliver the survey and for eligible patients will complete the pathology form but will not provide any medical advice or endorse completion of the intervention.

The general practitioner will endorse the FOBT during the patient’s appointment. The GP will reinforce the importance of completing the FOBT and recommend the patient complete the FOBT using a script provided by the research team during a pre-study training session.
Intervention code [1] 295364 0
Early detection / Screening
Comparator / control treatment
The usual care group will receive the usual care provided by their GP. This will include advice/ care related to the problem the patient is presenting with. No strategies will be implemented for the usual care group to facilitate routine provision of screening advice
Control group
Active

Outcomes
Primary outcome [1] 299018 0
Uptake of FOBT screening will be assessed via self-report in the intervention and usual care groups.
Timepoint [1] 299018 0
6 weeks post baseline
Secondary outcome [1] 325866 0
Change in colorectal cancer screening knowledge. Knowledge will be assessed by a questionnaire designed by the research group specifically for this study.
Timepoint [1] 325866 0
Baseline and six weeks post-baseline

Eligibility
Key inclusion criteria
Eligibility criteria for trial inclusion:
Patients aged 50-74 presenting for an appointment with the general practitioner and that are: 1) at average or slightly above average risk of colorectal cancer; 2) have had no faecal occult blood test within the last two years or a colonoscopy in the last five years, will be eligible for participation in the trial. Average risk will be assessed by four questions relating individual and familial history of colorectal cancer.
Minimum age
50 Years
Maximum age
74 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1) Those with a history of CRC or inflammatory bowel disease.
2) Those at greater than average risk of colorectal cancer
3) Non-English speaking
4) Too unwell to complete survey
5) Unable to complete survey for other reasons

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)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
This is a cluster randomised controlled trial with each recruitment day randomly allocated to either the intervention or control group. A statistician not involved in the day-to-day implementation of the project will generate separate computer generated randomisation tables for each participating general practice. Whilst the implementation cannot be concealed from the research assistant, they will not have access to the assignment schedule and only be made aware of allocation the day they attend the practice. A senior researcher not involved in patient recruitment will manage the randomisation list and liaise on a daily basis with the research assistants responsible for recruitment to inform them of the allocation for that day.
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
Aim 1: The proportion of patients completing CRC screening at the follow-up time point will be compared using a logistic regression model.
Aim 2: Differences in knowledge scores between the usual care group and the intervention group will be determined by ordinal logistic regression.

For all tests we will use 2-sided p-values with a 5% significance level.

The sample size was calculated on the basis of the primary aim. A sample of 50 patients per arm will enable detection of a 20% increase in self-reported CRC screening for patients in the intervention group compared to 5% in the usual care control group with 86% power at 5% significance. This calculation allows for a small design effect of 1.2 to allow for potential clustering by the design of the study (day of the week) and assumes on average 10 eligible patients will be available per day

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
19/09/2016
Actual
6/09/2016
Date of last participant enrolment
Anticipated
30/11/2016
Actual
15/05/2017
Date of last data collection
Anticipated
12/12/2016
Actual
4/07/2017
Sample size
Target
100
Accrual to date
Final
114
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 294113 0
Other Collaborative groups
Name [1] 294113 0
Hunter Cancer Research Alliance
Country [1] 294113 0
Australia
Funding source category [2] 294114 0
Charities/Societies/Foundations
Name [2] 294114 0
Rotary Australia
Country [2] 294114 0
Australia
Funding source category [3] 294115 0
Charities/Societies/Foundations
Name [3] 294115 0
MM Sawyer Trust
Country [3] 294115 0
Australia
Funding source category [4] 294404 0
Charities/Societies/Foundations
Name [4] 294404 0
Cancer Council NSW
Country [4] 294404 0
Australia
Primary sponsor type
University
Name
University of Newcastle
Address
University Drive
Callaghan
NSW 2308
Country
Australia
Secondary sponsor category [1] 293252 0
None
Name [1] 293252 0
Address [1] 293252 0
Country [1] 293252 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295521 0
University of Newcastle Human Research and Ethics
Ethics committee address [1] 295521 0
Ethics committee country [1] 295521 0
Australia
Date submitted for ethics approval [1] 295521 0
03/06/2014
Approval date [1] 295521 0
08/09/2014
Ethics approval number [1] 295521 0
H-2014-0198

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

Contacts
Principal investigator
Name 67602 0
A/Prof Mariko Carey
Address 67602 0
University of Newcastle
Health Behaviour Research Group
University Drive
Callaghan
NSW 2308
Country 67602 0
Australia
Phone 67602 0
+61 2 40420702
Fax 67602 0
Email 67602 0
[email protected]
Contact person for public queries
Name 67603 0
Mariko Carey
Address 67603 0
University of Newcastle
Health Behaviour Research Group
University Drive
Callaghan
NSW 2308
Country 67603 0
Australia
Phone 67603 0
+61 2 40420702
Fax 67603 0
Email 67603 0
[email protected]
Contact person for scientific queries
Name 67604 0
Mariko Carey
Address 67604 0
University of Newcastle
Health Behaviour Research Group
University Drive
Callaghan
NSW 2308
Country 67604 0
Australia
Phone 67604 0
+61 2 40420702
Fax 67604 0
Email 67604 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
No additional documents have been identified.