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Trial registered on ANZCTR


Registration number
ACTRN12614001015639
Ethics application status
Not yet submitted
Date submitted
26/08/2014
Date registered
22/09/2014
Date last updated
22/09/2014
Type of registration
Prospectively registered

Titles & IDs
Public title
Bowel Cancer Screening through General Practitioners in Port Macquarie
Scientific title
A Bowel Cancer Screening Initiative to evaluate the uptake of Faecal Occult Blood test (FOBt) when screening is facilitated through General Practice in Port Macquarie compared to the National Bowel Cancer Screening Initiative.
Secondary ID [1] 285230 0
Nil known
Universal Trial Number (UTN)
U1111-1160-9050
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Bowel Cancer 292859 0
Condition category
Condition code
Cancer 293158 293158 0 0
Bowel - Back passage (rectum) or large bowel (colon)
Public Health 293236 293236 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The study aims to improve rates of bowel cancer screening by assessing uptake of Fecal Occult Blood test via General Practice compared to direct mail through the National Bowel Cancer Screening Program.
Subjects will be invited to take part in the study during a routine visit to the GP. The GP or practice nurse will explain the study and provide the subject information and consent forms along with a FOBt kit to take home. How to use the kit will also be explained by the GP or practice nurse along with what the results mean.
The FOBt kit will be completed by the participant at home and mailed to the pathology lab. Results from the kit will be sent by the pathology lab to the participant and the GP and the University NSW assistant researcher collating the data.
If the kit is negative the GP will invite the participant back for another test kit in 2 years time as per medical guidelines. If the test kit is positive the participant will be invited back to see the GP and discuss the next step.
Subjects will be requested to consent to take part in the study for a total period of 6 months. Results of the FOBt will be recorded along with any further investigations which may be required. All data will be non-identifiable. Subjects have the right to withdraw at any time.
Intervention code [1] 290104 0
Prevention
Intervention code [2] 290105 0
Early detection / Screening
Comparator / control treatment
We will be comparing uptake of the FOBt kit through GP's during the 6 month period of data collection, compared to uptake via the National Bowel Cancer Screening Program by comparing to the monitoring report.
Reference: AIHW 2012. National Bowel Cancer Screening Program monitoring report: phase 2, July 2008- June 2011.
Control group
Historical

Outcomes
Primary outcome [1] 293016 0
On initial presentation to their GP, subjects who have consented to take part in the study will be given information (written & verbal) on bowel cancer screening and offered an FOBt kit.
The number of FOBt kits offered compared to returned kits (results data recorded by the pathology company) will be compared to the same in the National Bowel Cancer Screening Program.
Timepoint [1] 293016 0
The primary time point (baseline) will be the day of signing the consent form and being given bowel cancer screening education and an FOBt kit.
Once the kits have been dispensed participants are given a time period within which to return them (3 months) and for results to be recorded by the pathology company.
The primary time point is baseline where number of participants are recorded along with number of kits distributed.
Secondary outcome [1] 310156 0
A composite secondary outcome will be the number of returned FOBt kits and the number of positive and negative results. This data will be made available by Douglas Hanley Moir Pathology company who will conduct all analysis of the FOBt kits for this study. The data will be categorised for age in 5 year increments.
Timepoint [1] 310156 0
The active recruitment of subjects to the study will be conducted for 6 months. FOBt results data will continue to be recorded for a further 3 months after recruiting has finished. This is to allow time for subjects recruited in the sixth month to conduct their FOBt kit and send it in to Douglas Hanley Moir Pathology.
Secondary outcome [2] 310157 0
The third outcome will look at the number of participating subjects who receive a positive FOBt results who then go on to have a colonoscopy. This data will then be compared to the National Bowel Cancer Screening campaign.
Not all participants with a positive FOBt result will go on to have a colonoscopy, the GP may advise against due to other medical reasons, or the client may refuse.
The study is looking at participation rates. Participation will be measured by the amount of FOBt kits offered to clients and the amount completed and returned, along with the numbers of participants with positive FOBt's going on to have colonoscopy, and compared to the same participation measures in the National Bowel Cancer Screening Program. The GP will inform the study research assistant of participants going on to have a colonoscopy.
Timepoint [2] 310157 0
This outcome will be recorded at the end of the 9 month study period.
Secondary outcome [3] 310370 0
A short questionnaire will be conducted at baseline to establish age, family history and knowledge of bowel cancer risk and if screening has been conducted before, if declining screening - reasons for declining.
An additional questionnaire will be mailed to subjects who consented to take part asking if they completed the FOBt kit, did they find the GP/practice nurse of assistance in making the decision to do the FOBt kit, and if they did not do the FOBt kit why not.
Timepoint [3] 310370 0
This questionnaire will be given to participating subjects at baseline and the second questionnaire will be sent to participating subjects three months after being recruited to the study.

Eligibility
Key inclusion criteria
Male and female clients visiting their GP who are 40 years or older.
Minimum age
40 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Inability to make informed consent (for example dementia).
Client declines to take part or conduct an FOBt.
Presence of IBD or bowel cancer.
Any other reason where a GP professionally decides an FOBt is inappropriate.

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
During a routine visit to their GP, patients will be provided with information on the study and offered to take part. Details of patient consenting to take part will be recorded along with their completed questionnaire. Participants will then be instructed on how to use the FOBt kit by the GP or nurse. The participant will leave with the FOBt kit, instructions for use, and information pack along with copies of signed consent forms.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
There is no randomisation in this study. This is an expansion of normal general practice where other routine screening is completed. We are incorporating FOBt into the normal general practice surrounding screening.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
The measures are purely looking at participation. The number of participants given the FOBt kit, and instructions for use compared to the participation rate of the National Bowel Cancer Screening Program. We would anticipate a higher participation rate compared to the National Bowel Cancer Screening Program
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
The population size of the target town is approximately 40,000 people looking at 2011 census data. Of this data approximately 25000 are 40 years of age and older.

Using the formula below we have calculated we will be aiming for 1064 participants.

N= 25,000 (males and females 40 years and older in Port Macquarie)
e= 3 percentage margin of error (0.03)

N / ( 1 + N*e^2 )
25000 divided by (1+25000x0.0009) = 1063.8


Recruitment
Recruitment status
Not yet 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)
NSW
Recruitment postcode(s) [1] 8637 0
2444 - Port Macquarie

Funding & Sponsors
Funding source category [1] 289840 0
Charities/Societies/Foundations
Name [1] 289840 0
The Gut Foundation
Address [1] 289840 0
201 Avoca Street
Randwick NSW 2031
Country [1] 289840 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
The Gut Foundation
Address
201 Avoca Street
Randwick NSW 2031
Country
Australia
Secondary sponsor category [1] 288530 0
None
Name [1] 288530 0
none
Address [1] 288530 0
Country [1] 288530 0
Other collaborator category [1] 278139 0
University
Name [1] 278139 0
University of New South Wales
Address [1] 278139 0
Rural Clinical School
26 Highfields Circuit,
Port Macquarie, NSW, 2444
Country [1] 278139 0
Australia

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 291573 0
University of New South Wales Human Research Ethics Committee
Ethics committee address [1] 291573 0
UNSW Research Ethics & Compliance Support

Level 3, Rupert Myers Building (South)

The University of New South Wales

Sydney NSW 2052 Australia
Ethics committee country [1] 291573 0
Australia
Date submitted for ethics approval [1] 291573 0
30/09/2014
Approval date [1] 291573 0
Ethics approval number [1] 291573 0

Summary
Brief summary
This study is evaluating the effect of a bowel cancer screening initiative facilitated through General Practice in Port Macquarie compared to the National Bowel Cancer Screening Initiative.

Who is it for?
You may be eligible to join this study if you are aged 40 years or above, have no history of inflammatory bowel disease or bowel cancer, and visit a participating general practice in the Port Macquarie area during the study period.

Study details
Participants in this study will be asked to complete a short questionnaire and complete a bowel cancer screening kit called a Faecal Occult Blood test. This kit detects hidden blood in the stool which may be present due to polyps in the bowel. Polyps are the precursors for bowel cancer and can usually be easily removed preventing bowel cancer.
The test kit can be conducted in the privacy of your own home and your GP will manage any follow ups or further tests you may require.
Screening is really important to prevent bowel cancer.

How long does the study go for?
We are looking to recruit participants for a period of 6 months. If you agree to take part in the study, you will be asked to complete a questionnaire and a bowel cancer screening kit (an FOBt). If your screening kit comes back negative, there are no further tests we require and you will be asked to complete another questionnaire. If your test comes back positive for blood in your stool, your GP may ask you to have a further test called a colonoscopy. How long it takes for this test to be completed depends on waiting lists with specialists. After the colonoscopy you will be asked to complete a final questionnaire. This then marks the end of your participation in the study.
Trial website
please see www.gutfoundation.com for any further information or contact details.
Trial related presentations / publications

Public notes

Contacts
Principal investigator
Name 50954 0
A/Prof Terry Bolin
Address 50954 0
The Gut Foundation
201 Avoca Street
Randwick NSW 2031
Country 50954 0
Australia
Phone 50954 0
+61 2 93983222
Fax 50954 0
Email 50954 0
katherine@gutfoundation.com.au
Contact person for public queries
Name 50955 0
Ms Katherine Collings
Address 50955 0
The Gut Foundation
201 Avoca Street
Randwick NSW 2031
Country 50955 0
Australia
Phone 50955 0
+61 430707248
Fax 50955 0
Email 50955 0
katherine@gutfoundation.com.au
Contact person for scientific queries
Name 50956 0
Ms Katherine Collings
Address 50956 0
The Gut Foundation
201 Avoca Street
Randwick NSW 2031
Country 50956 0
Australia
Phone 50956 0
+61 2 95011848
Fax 50956 0
Email 50956 0
katherine@gutfoundation.com.au

No data has been provided for results reporting
Summary results
Not applicable