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Trial registered on ANZCTR


Registration number
ACTRN12609000628246
Ethics application status
Yes
Date submitted
22/07/2009
Date registered
28/07/2009
Date last updated
Type of registration
Prospectively registered

Titles & IDs
Public title
Increasing appropriate screening for colorectal cancer patients and their first degree relatives. A randomised controlled trial.
Scientific title
The effect of an educational intervention versus minimal ethical care on the level of appropriate screening for colorectal cancer patients and their first degree relatives. A randomised controlled trial.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Colorectal Cancer 237309 0
Condition category
Condition code
Cancer 239633 239633 0 0
Bowel - Back passage (rectum) or large bowel (colon)
Cancer 239634 239634 0 0
Bowel - Anal
Cancer 239635 239635 0 0
Bowel - Small bowel (duodenum and ileum)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
People with bowel cancer and their first degree relatives will be allocated to an intervention or minimal ethical care group. Those in the intervention group will be posted a detailed information booklet about screening tests recommended by the National Health and Medical Research Council (NHMRC). A corresponding information booklet will also be mailed to their General Practitioner (GP) and for index cases only, cancer surgeon. This tailored advice on screening will be provided to participants and their clinicians within 4 weeks of recruitment, and 12 and 24 months later.
Intervention code [1] 236985 0
Prevention
Intervention code [2] 236987 0
Early detection / Screening
Comparator / control treatment
Those allocated to the minimal ethical care group will each receive one standard pamphlet about bowel cancer within four weeks of recruitment.
Control group
Active

Outcomes
Primary outcome [1] 238418 0
Proportion of first degree relatives and index cases who have screening in line with NHMRC guideline recommendations will be assessed through self-report.

Accuracy of self-report will be tested for a random sub-sample. This will be carried out by cross-checking self-reported screening with clinician records.
Timepoint [1] 238418 0
Measured at baseline, 12, 24 and 36 months after intervention.
Secondary outcome [1] 244995 0
Nil
Timepoint [1] 244995 0
Nil

Eligibility
Key inclusion criteria
Index Cases - People who have received a confirmed diagnosis of bowel cancer no more than 6 months previously.

First degree relatives - Of people with bowel cancer particpating in the trial.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Index cases - People with familial adenomatous polyposis or hereditary non-polyposis colorectal cancer (HNPCC). Non-English speaking.

First-degree Relatives - Those with familial adenomatous polyposis or hereditary non-polyposis colorectal cancer (HNPCC), ulcerative colitis, Crohn’s disease, inflammatory bowel disease or a previous diagnosis of bowel cancer. Non-English speaking.

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 will be concealed as participants will be randomly allocated to groups by central randomisation with a computer.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint(s)
Efficacy
Statistical methods / analysis

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 outside Australia
Country [1] 252548 0
State/province [1] 252548 0

Funding & Sponsors
Funding source category [1] 237369 0
Government funding body e.g. Australian Research Council
Name [1] 237369 0
NHMRC
Address [1] 237369 0
Level 1
16 Marcus Clarke Street
Canberra ACT 2601
Country [1] 237369 0
Australia
Primary sponsor type
University
Name
The University of Newcastle
Address
University Drive
Callaghan,
Newcastle, NSW, 2308
Country
Australia
Secondary sponsor category [1] 236865 0
None
Name [1] 236865 0
Address [1] 236865 0
Country [1] 236865 0

Ethics approval
Ethics application status
Yes
Ethics committee name [1] 239500 0
The Cancer Council Victoria Human Research Ethics Committee
Ethics committee address [1] 239500 0
1 Rathdowne St,
Carlton,
Victoria, 3053
Ethics committee country [1] 239500 0
Australia
Date submitted for ethics approval [1] 239500 0
Approval date [1] 239500 0
10/07/2008
Ethics approval number [1] 239500 0
HREC 0810
Ethics committee name [2] 239501 0
The University of Newcastle Human Research Ethics Committee
Ethics committee address [2] 239501 0
University Drive,
Callaghan,
Newcastle,
NSW, 2308
Ethics committee country [2] 239501 0
Australia
Date submitted for ethics approval [2] 239501 0
Approval date [2] 239501 0
Ethics approval number [2] 239501 0
H-2008-047

Summary
Brief summary
This research aims to improve adherence to guideline recommendations for surveillance for people with colorectal cancer and screening of their first degree relatives using an educational intervention. People with colorectal cancer and their first degree relatives will be randomly assigned to receive tailored educational materials on screeening (intervention group) or standard pamphlets (minimal ethical care group). It is expected that those in the intervention group will have 10%, 12% and 15% higher levels of adherence to screening/surveillance recommendations at 1, 2, and 3 years post recruitment respectively, when compared with those in the minimal ethical care group.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Contact person for public queries
Contact person for scientific queries

No information has been provided regarding IPD availability
Summary results
No Results