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Adherence to Minimally Invasive Testing

ABSTRACT: Colorectal cancer (CRC) screening has been demonstrated to reduce long term disease burden and costs. Unfortunately, less than 65 % of age-eligible persons in the US are actually screened for CRC. The leading methods, colonoscopy and FIT (fecal immunochemical test) testing, both have patient-associated barriers that reduce their use. The combination of bowel preparation and procedure time are barriers to colonoscopy, while stool handling as part of the sampling protocol reduces FIT usage. It has been hypothesized and supported by a variety of preference studies that the availability of a blood-based assay for CRC screening would increase patient participation and adherence to CRC screening by reducing barriers that prevent participation. This study is designed to investigate the relative participation in CRC screening in average risk, screening eligible patients with demonstrated non-adherence to guideline-recommended screening modalities. Participation with the fecal immunochemical test (FIT) and the blood-based Epi proColon test will be examined. Screening eligible average-risk patients identified as non-adherent by medical record will be eligible for the study. Potential subjects will be recruited to participate in a study via mailing and/or at a clinic visit. All study subjects will be enrolled at a clinic visit and will be randomized in two study arms. Those assigned to Arm 1 will be offered a FIT test kit for home use. Those assigned to Arm 2 will be offered a blood draw for the Epi proColon test. Rates of adherence will be compared between those that accept and complete the blood test and those that accept and complete the FIT test. A passive control, usual care arm will comprise subjects meeting eligibility criteria, but not recruited for or participating in the study. In conjunction with published data (Johnson et al, 2014), the relative utilization of the blood test will be compared to the screening participation via FIT. Increased participation with the Epi proColon blood test could increase screening rates in the non-adherent population. Additionally, for those testing positive in the trial, the rate of adherence to colonoscopy will be determined.

DISEASE(S): Colorectal Cancer,Colorectal Neoplasms

PROVIDER: 2175283 | ecrin-mdr-crc |

REPOSITORIES: ECRIN MDR

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Project description:Early detection by screening significantly reduces mortality from colorectal cancer (CRC). However, CRC screening rates have plateaued, with a considerable segment of the population remaining unscreened. Not being up to date with screening was associated with an approximate 3-fold risk for CRC-related mortality. There are different well-established CRC screening modalities, including invasive and non-invasive, which detect both polyps and cancer or cancer alone. Colonoscopy remains the dominant screening modality in the U.S.; however, colonoscopy uptake is low due to the invasiveness, perception of discomfort and embarrassment, logistical challenges, cost, and potential risks. Increasing patient compliance and adherence to screening is critical to improving CRC outcomes. A key to enhancing screening participation is patient acceptance of the testing method. A blood-based screening test presents an opportunity to overcome some challenging barriers. Blood-based tests are non-invasive compared to colonoscopy and can easily be part of a standard medical office appointment for a wellness check or scheduled visits to manage chronic illnesses and be completed at the point of care. This study will examine patient preference to use a blood-based screening test and compliance with CRC screening recommendations after failing to complete the FIT (Fecal Immunochemical Test)/FOBT (Fecal Occult Blood Test) or colonoscopy order in six months. Compliance with CRC screening is particularly poor among medically underserved populations, and most of these vulnerable individuals use federally qualified health centers (FQHCs) to obtain care. Implementing a blood-based screening test at FQHCs has the potential to improve CRC screening uptake and adherence and improve health disparities in medically underserved populations. This study seeks to answer the following four questions: 1) What is the acceptability of a blood-based screening as an alternative for patients who failed to complete a prior order using traditional screening methods? 2) Are patients who failed to comply with traditional screening methods more likely to comply with a blood-based screening test? 3) What is the effect of offering a blood-based screening test for patients who are non-compliance with traditional screening methods on overall CRC screening rates? 4) What are the facilitators and barriers to implementing the blood-based screening test in clinical settings?

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Adherence to Minimally Invasive Testing

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