A blood test for improving participation in bowel cancer screening

Will people at average risk for developing colorectal cancer, who are offered a screening program for colorectal cancer (CRC) that includes a blood test in addition to faecal occult blood tests (FOBT) participate at a significantly greater rate relative to people offered a screening program consisting of FOBT only.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12613001365752

Acronym

WolRes

Enrollment

1200

Registered

2013-12-13

Start date

2013-10-15

Completion date

2013-12-10

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

The study aim is to determine whether the availability of a simple blood test for colorectal cancer will improve participation in screening for colorectal cancer (CRC). Our hypothesis is that a blood test will improve participation in screening for CRC. Patients attending General Practices in Adelaide that are involved in the study, who are aged 50-74 years old and are at average risk for bowel cancer may be invited to participate in this study. Study details: Many people do not participate in stool (faecal) sample-based screening programs for early detection of colorectal cancer because of their dislike for the test. The purpose of this research is to determine if a blood test for colorectal cancer, if offered to people who have just declined a standard faecal occult blood (FOB)-based screening test, will be completed and result in a significant improvement in the overall program participation rate, relative to a program where only faecal occult blood test (FOBT) is offered. Participants in this study will be randomly (by chance) allocated to one of two programs – one where they are offered the blood test if they declined the FOBT provided through the study, and one where FOBT is offered twice. We will assess how many of these invitees completed a screening test and compere participation rates between groups.

Interventions

The intervention is a screening program for CRC that includes the availability of a blood test for CRC. The intervention group are initially mailed an offer of screening for bowel cancer by FOBT. At 12 weeks from date of the FOBT-screening offer, subjects who have not participated in FOBT-screening are mailed a second invitation to screen for CRC using a blood test for CRC. Intervention group subjects contact the study Help-Line to request a referral to a pathology service for a blood to be

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Prevention

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

50 Years to 74 Years

Healthy volunteers

Yes

Inclusion criteria

General Practice patients average risk for bowel cancer

Exclusion criteria

Unable to provide informed consent. Unsuitable for CRC screening as judged by the person's GP. Medical record documented recent CRC screening within previous 2 years (FOBT/FIT; colonoscopy within 5 years) or participating in appropriate high risk CRC surveillance. Patients who are likely to be sent a test from the NBCSP within the expected study duration. Otherwise deemed unsuitable for screening offer by the GP (eg poor English language comprehension or inability to follow protocol).

Outcome results