Clinical trial NCT02251782: Adherence to Minimally Invasive Testing
Official title: Adherence to Minimally Invasive CRC Screening In Non-Adherent Patients Who Have Not Completed Colorectal Cancer Screening
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Colorectal Cancer
Lead sponsor: Epigenomics, Inc
Sponsor class: INDUSTRY
First posted: 2014-09-29
Enrollment: 490
Sex: ALL
Minimum age (years): 50
Maximum age (years): 76
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
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).

Brief 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.


Eligibility criteria: Inclusion Criteria:

* 50 years of age or greater, but less than 76 years old
* Has not completed recommended screening for colonoscopy or FIT

  * No colonoscopy in previous 10 years
  * No fecal occult blood test (FOBT) or FIT in previous year and/or \> 13 months late FIT
* No flexible sigmoidoscopy in previous 5 years
* Verifiable offer of screening recommendation according to health system standard in at least two independent interactions and a verifiable lack of adherence for two most recent
* Verifiable lack of adherence for \>3 months following last screening recommendation
* Primary Care Provider (PCP) has agreed to refer patients for consideration of enrollment in the study
* Subject able to understand and sign written informed consent (IC)

Exclusion Criteria:

* Family history of CRC in a first-degree relative
* Personal history of colonic adenomatous polyps, CRC or inflammatory bowel disease
* Symptoms for which colonoscopy or sigmoidoscopy would otherwise be performed (hematochezia, new onset diarrhea or constipation, abdominal pain)
* Comorbid illness precluding endoscopic evaluation (coronary artery disease with myocardial infarction within 6 months, unstable angina or congestive heart failure, chronic obstructive pulmonary disease requiring home oxygen, other diseases that limit life expectancy to less than 10 years)
* Chronic gastritis, pregnancy, cancer(s) other than colorectal

Primary outcomes:
measure: Comparison of Adherence to Screening for Each Group
timeFrame: 9 months
Secondary outcomes:
measure: Adherence to follow-up colonoscopy for tests with a positive result:
timeFrame: 9 months
measure: Diagnostic yield of colonoscopy:
timeFrame: 9 months
Other outcomes:
Locations:
city: Portland
country: United States
facility: Kaiser Permanente Center for Health Research
state: Oregon
city: Danville
country: United States
facility: Geisinger Clinic
state: Pennsylvania
Study officials:
affiliation: Director Development & Commercial Operations
name: Theo deVos, Ph.D.
role: STUDY_DIRECTOR
References: