Adherence to Minimally Invasive Testing
Condition: Colorectal Cancer
MeSH terms: Colorectal Neoplasms
Study type: Observational

Summary: 
      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.
    


Intervention name(s): Epi proColon Test; Fecal Immunochemical Test (FIT)
Intervention type(s): Device; Device
Intervention description(s): Subjects assigned to the Epi proColon arm will receive information on the Epi proColon test outlined in a template script. They will then be offered a blood draw for Epi proColon testing. The blood draw can be fulfilled at the clinic or at a specified blood draw station, at the convenience of the patient. Epi proColon plasma samples will be sent to a central laboratory for testing. If no test result is recorded within 4 weeks, patients will be mailed a reminder to complete testing. If no result is recorded within 2 weeks of the mailed reminder, subjects will be recorded as non-adherent to screening. Subjects with negative test results will be mailed a notice of result and reminder to continue screening. Subjects with positive tests will be contacted and counseled to undergo colonoscopy.; Subjects assigned to the FIT arm will receive information on the FIT test outlined in a template script. They will then be provided a FIT kit to take home and asked to send a stool sample to the testing lab following the kit instructions. If no test result is recorded within 4 weeks, subjects will receive a mailed reminder to complete testing. If no result is recorded within 2 weeks of the mailed reminder, subjects will be recorded as non-adherent to screening. Subjects with negative test results will be mailed a notice of result and reminder to continue screening. Subjects with positive tests will be contacted and counseled to undergo colonoscopy.
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        The study population will encompass users of outpatient primary care clinics of one or more
        health care systems who are considered to be at average-risk for developing colorectal
        cancer (CRC), have not completed standard screening options, and are not up-to-date with a
        screening program. Such health care systems may include large healthcare networks with
        relatively stable patient bases such as Geisinger Health Systems (Danville, PA), Kaiser
        Permanente (Portland, OR).