Dataset Information

Optimising men’s participation in faecal occult blood test screening for bowel cancer.

ABSTRACT: Interventions: Name of intervention: gender specific mail-administered screening invitation strategies. All participants will receive an offer to participate in a free FOBT which will be delivered by mail. Intervention arms will differ from control according to the information included in the materials accompanying the screening offer. All study participants will receive a standard screening reminder irrespective of their intervention group. Intervention materials will target specific psychosocial variables previously identified as being related to male participation in FOBT screening. The intervention period is 14 weeks. All participants will receive a screening offer according to the following timeline. Baseline: Advance notification letter sent Week two: Invitation package sent Week eight: Reminder letters sent to those who have not completed an FOBT Week 14: Data collection ceases. Arm 1: Control The control arm will receive a standard offer to participate in FOBT screening designed to mimic the strategy utilised by the Australian national bowel cancer screening program (NBCSP). The standard offer includes an advance notification letter and a screening invitation package. The advance notification letter is sent two weeks prior to the screening invitation package and is designed to alert participants that an invitation to screen for CRC with an FOBT will soon follow. The standard advance notification letter introduces basic information about colorectal cancer and the health benefits of screening. The screening invitation package includes a) a screening invitation letter b) an immunochemical FOBT with associated instructions c) an information booklet that describes colorectal cancer and screening and d) a particip Primary outcome(s): Rate of FOBT participation per trial arm as assessed by number of FOBT screening tests returned.[At 14 weeks from baseline, 12 weeks after receiving the FOBT.] Study Design: Purpose: Prevention; Allocation: Randomised controlled trial; Masking: Blinded (masking used);Assignment: Factorial;Type of endpoint: Efficacy

DISEASE(S): Cancer-bowel-back Passage (rectum) Or Large Bowel (colon),Public Health-other Public Health,Colorectal Cancer Screening

PROVIDER: 2458819 | ecrin-mdr-crc |

REPOSITORIES: ECRIN MDR

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Project description:Interventions: The intervention is a bowel cancer screening program that includes the availability of a screening blood test after an offer of the standard faecal occult blood test (FOBT). There are two intervention groups (n = 600 per group). Everyone in the intervention will be initially mailed an offer of screening for bowel cancer by FOBT. For the first intervention group, after 12 weeks anyone who has not participated with the FOBT will be mailed an offer of screening for bowel cancer by blood test (the methylated BCAT1/IKZF1 blood test). They will then need to call the study helpline to request a further blood test information. The second intervention group will be sent the offer for the blood test at the same time as receiving the FOBT. They will be advised that if they believe that the FOBT is not suitable for them they might consider screening for bowel cancer by blood test. They will then need to call the study helpline to request a further blood test information. Anyone requesting the blood test will then be sent information about the test (including accuracy of the test, where they can get their blood collected, and when they will receive their test results) and a test referral. They can then take up the offer of the free screening blood test at one of 10 local blood collection centres (Healthscope). They do not need to be fasted and appointments do not need to be made. Reminder letters will be sent to non-participants 6 weeks after each type of screening test offer. Participants of the FOBT will be required to collect a small sample from two separate bowel movements. These samples are then sent via reply-paid mail to a laboratory which tests the samples for the presence of blood. If more than 100ng/mL of blood is present in either sample, Primary outcome(s): Total participation rate in a bowel cancer screening program that offers a FOBT followed by a blood test, compared to a program that only offers FOBT. This will be assessed at the 24 week timepoint by review of laboratory records.[24 weeks after the initial screening offer.] Study Design: Purpose: Prevention; Allocation: Randomised controlled trial; Masking: Open (masking not used);Assignment: Parallel;Type of endpoint: Efficacy

Dataset Information

Optimising men’s participation in faecal occult blood test screening for bowel cancer.

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