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Trying to improve the compliance to colorectal cancer screening: type of test provider (GP versus hospital) and type of faecal occult blood test (Guaiac versus immunochemical)

ABSTRACT: Study hypothesis: The efficacy of colorectal cancer screening (CRCS) using faecal occult blood test (FOBT) in reducing colorectal cancer (CRC) mortality in a population at generic risk, has been shown in several large randomized trials. The screening programs need to contact the whole target population and involve as many people as possible in order to be actually effective. The scientific literature about the reasons for non-compliance have generated few definitive operational recommendations. Two types of FOBT are now available: the Guaiac and the Immunochemical test. The sensitivity and specificity of the two tests are similar and do not clearly indicate which one is better for screening. The price of the immunochemical test is actually about 1.5 times higher than the Guaiac, but there are no data about the costs per person screened. The Guaiac test recommends three different evacuations, and requires the patient to store the samples, and follow dietary restrictions. The immunochemical test is recommended on a single evacuation and does not require dietary restrictions. The discomfort and embarrassment of faecal sampling and the dietary restrictions have been hypothesized to be determinants of non-compliance. This background may determine lower compliance to the Guaiac test. Several guidelines for screening programme implementation recommend the involvement of general practitioners (GP) and family practitioners (FP); nevertheless the role of the GPs and FPs varies between countries and health service organizations, making this recommendation hard to implement. The Agency for Public Health of Lazio, Italy, decided to design a trial phase in order to plan an evidence-based implementation of the CRCS program. The aim of this approach is to guarantee that the efficacy of CRCS can be translated to effectiveness in a public health intervention. The screening strategy adopted was: yearly FOB testing for 5074 year olds and, for positives, colonoscopy. A special focus was how to obtain a high compliance to screening; the topics studied were: GPs attitudes and practices, type of FOBT, test provider, and the individual reasons. Studies included: a survey, a randomized factorial trial nested in the survey, and a casecontrol study nested in the trial. Primary outcome(s): Compliance to screening: (number of returned faeces samples)/(total number of invited subjects)

DISEASE(S): Colorectal Cancer

PROVIDER: 2424493 | ecrin-mdr-crc |

REPOSITORIES: ECRIN MDR

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Project description:Colorectal cancer (CRC) is the second leading cause of cancer death in the United States and affects men and women almost equally. The United States Preventative Services Task Force (USPSTF) currently recommends screening with any of three options, which include fecal testing, flexible sigmoidoscopy, or colonoscopy. Screening for CRC with fecal occult blood testing (using a guaiac-based test) done annually or biennially has been shown to decrease mortality 15-33% primarily through detection of early stage cancer. Guaiac fecal occult blood testing (gFOBT) has a known positive balance of benefit and risk in screening populations, is the least expensive, and is the preferred method of screening in 30-55% of patients. The fecal immunochemical test (FIT) offers significant improvements over the gFOBT, most notably that it is easier to use (requires fewer samples and no dietary or medication restrictions) and is more sensitive than the gFOBT with respect to detecting both CRC and precancerous adenomas. As a result of improved test performance and usability, in 2008 multiple professional societies endorsed the use of four types of FITs for colorectal cancer screening. Kaiser Permanente currently uses the OC-Micro FIT as the fecal screening test in all regions. In recent years, intensive efforts have been undertaken to identify blood-based markers that may provide a promising alternative or supplement to fecal testing for non-invasive CRC screening. One method under development is to identify aberrantly methylated genes in cancer tissue through a blood test. Prior studies have explored those specific colorectal cancer genes that show the highest differences in methylation between the cancer and background genetic expression. Of these, methylation of the Septin 9 gene through a qPCR assay is relatively well studied. The proposed study aims to evaluate whether the Septin 9 biomarker may be used to supplement the OC-Micro FIT for colorectal cancer screening in such a way as to safely reduce unneeded colonoscopies. The population of interest for this study-those with a positive screening OC-Micro fecal immunochemical test-has a CRC prevalence of approximately 5%. Knowing how well Septin 9 can identify those without cancer prior to colonoscopy is important largely because colonoscopy, even when done diagnostically (e.g., after a positive FIT result), can cause serious complications.

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Trying to improve the compliance to colorectal cancer screening: type of test provider (GP versus hospital) and type of faecal occult blood test (Guaiac versus immunochemical)

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