Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12605000461695
Ethics application status
Approved
Date submitted
9/09/2005
Date registered
22/09/2005
Date last updated
22/09/2005
Type of registration
Retrospectively registered

Titles & IDs
Public title
The value of GP endorsement on participation in rescreening for colorectal cancer
Scientific title
The value of GP endorsement on participation in rescreening for colorectal cancer
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Screening for bowel cancer 578 0
Condition category
Condition code
Cancer 652 652 0 0
Bowel - Back passage (rectum) or large bowel (colon)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The aim is to determine the value of GP endorsement for faecal occult blood test based re-screening colorectal cancer. The interventions are conducted within the setting of a population screening program where invitees are recruited from general practice patient lists.
Intervention 1: Invitation letter to re-screen on central screening facility letterhead with statement from invitee's general practice endorsing participation in screening, signed by screening coordinator.
Intervention 2: Invitation letter to rescreen on practice letterhead with statement from practice endorsing screening, signed by invitee's general practitioner.
Comparison group: recruited from electoral roll receiving control invitation to rescreen.
Duration: Four annual rounds of screening offers.
All people received the same invitation type over the 4 rounds of screening invitations.
Intervention code [1] 446 0
Early detection / Screening
Comparator / control treatment
Control: Generic invitation to re-screen for colorectal cancer letter on central screening facility letterhead, signed by screening coordinator.
Control group
Active

Outcomes
Primary outcome [1] 772 0
Paricipation in screening defined as return of a screening kit 12 weeks from offer.
Timepoint [1] 772 0
Secondary outcome [1] 1565 0
Test positivity rate
Timepoint [1] 1565 0
Secondary outcome [2] 1566 0
Yield of neoplasia
Timepoint [2] 1566 0

Eligibility
Key inclusion criteria
All people on patient lists of 2 general practices.
Minimum age
50 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
People identified by the collaborating practices and practitioners as having gastrointestinal conditions that invalidate screening results, people with mental and physical disabilities that prevent them from following the study protocol, people known to have had a neoplasia negative colonoscopy 5 years prior to a screening offer, people who inform the screening facility that they do not want further contact.

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)
Invitees are randomised to one of 4 invitation groups that differ by invitation type or source of subjects. Allocation to invitation group is not concealed from the investigators and office staff who print and package invitation kits for postal delivery, but there is no direct contact with between investigators and invitees. Invitees are unaware that there are more than one invitation type. A help line is available and inquiries are answered without knowledge of invitation type.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Group sizes of 600 each were determined by power analysis assuming that an intervention that produces a 10% increase in participation over control is a significant program improvement. For people aged 50-80 recruited from general practices, practice lists were were firstly combined. All people were assigned a random number using the MicroSoft Excel RAND function. The listing was ordered by ascending random number. The first 600 people were assigned to Intervention group 1 (Generic letter), the second 600 to Intervention group 2 (endorsement from practice) and the third 600 to the Intervention group 3 (strong endorsement, signed by GP). For the comparison group (people recruited from the electoral roll), 600 people aged 50-80 were randomly selected. All were allocated to a single group.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
6/12/2000
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
2400
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 717 0
Commercial sector/Industry
Name [1] 717 0
Beckman Coulter Inc
Country [1] 717 0
Funding source category [2] 718 0
Commercial sector/Industry
Name [2] 718 0
Enterix Australia
Country [2] 718 0
Australia
Funding source category [3] 719 0
Charities/Societies/Foundations
Name [3] 719 0
Bushel Fund
Country [3] 719 0
Primary sponsor type
Individual
Name
Prof. Graeme Young MD, FRACP
Address
Country
Secondary sponsor category [1] 597 0
Individual
Name [1] 597 0
Mr Stephen Cole
Address [1] 597 0
Country [1] 597 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 1919 0
Repatriation General Hospital Daw Park
Ethics committee address [1] 1919 0
Daws Rd, Daw Park, SA 5041
Ethics committee country [1] 1919 0
Australia
Date submitted for ethics approval [1] 1919 0
Approval date [1] 1919 0
Ethics approval number [1] 1919 0

Summary
Brief summary
Improved participation in screening for bowel cancer is desirable. Large scale screening programs must recruit invitees through comprehensive population registers. Depending on the country and health system these may be primary care practice lists or other registers such as the electoral roll. If primary care patient lists are available, considerable practice time may be required to organise the screening program, alternatively the implicit practice endorsement of screening may increase the participation rate to make that investment worthwhile. As screening is most effective when conducted regularly, it is important to determine if any increase in participation rate due to practice or practitioner endorsement is maintained over several rounds of screening offers. This study aims to follow screening participation over 4 rounds of offers in 4 treatment groups, and to use innovative statistical methods to determine the value of practice involvement in re-sceening participation.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35777 0
Address 35777 0
Country 35777 0
Phone 35777 0
Fax 35777 0
Email 35777 0
Contact person for public queries
Name 9635 0
Ms Alicia Smith
Address 9635 0
Bowel Health Service
Repatriation General Hospital Daw Park
Daws Rd
Daw Park SA 5041
Country 9635 0
Australia
Phone 9635 0
+61 8 82751075
Fax 9635 0
+61 8 02751083
Email 9635 0
[email protected]
Contact person for scientific queries
Name 563 0
Mr Stephen Cole
Address 563 0
Bowel Health Service
Repatriation General Hospital Daw Park
Daws Road
Daw Park SA 5041
Country 563 0
Australia
Phone 563 0
+61 8 82751838
Fax 563 0
+61 8 82751083
Email 563 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.