Maximizing Yield of the Fecal Immunochemical Test for Colorectal Cancer Screening (MY-FIT)

Colorectal cancer (CRC) is a leading cause of cancer death in the United States. Screening for CRC reduces CRC mortality, yet rates of screening in the United States remain low. Fecal occult blood testing (FOBT) has an established positive balance of benefit and risk, is the least expensive, and is the preferred method for nearly half of patients. A newer fecal screening test, the fecal immunochemical test (FIT), offers significant improvements over the FOBT. It is easier to use and is more sensitive at detecting both CRC and precancerous adenomas than the FOBT. The OC-Micro FIT is of particular interest because it is highly sensitive and specific and it is the only FIT test approved in the US that can be processed in an automated manner. Thus, the OC-Micro is an optimal method for use in mass screening programs to improve community CRC-screening rates. However, prior studies of OC-Micro suffer from several limitations: they were conducted in populations not optimal for assessing screening performance in average risk patients in the U.S. and the studies did not clearly establish optimal number of samples required and cut-points for test positivity. Therefore, the overall goal of MY-FIT is to capitalize on the highly integrated and extensive electronic medical record system of the study site to collect two separate sets of data that, when synthesized, will provide a thorough picture of the comparative patient adherence to, sensitivity, specificity, and costs of different protocols for using the OC-Micro FIT. Specifically, among KPNW members aged 50-75 who are at average risk for colorectal cancer (CRC) and who are due for CRC screening (n=78,000), the investigators propose to:

1. Compare the sensitivity, specificity, positive predictive value, and negative predictive value for colorectal cancer and advanced adenoma (advanced neoplasia) between a single-sample FIT (1-FIT) and a two-sample FIT (2-FIT) using varying cut points for a positive test (n=2100).
2. Compare patient adherence to completion of a 1-FIT versus a 2-FIT protocol (n=3000).
3. Assess and compare cost per screen for a 1-FIT versus a 2-FIT protocol, and the cost per advanced neoplasia detected in a 1-FIT versus a 2-FIT protocol (using varying cut points for a positive test) (n=78,000).

Answering the above questions will provide a much-needed strong evidence base for a best-practice, cost-effective method of using the OC-Micro FIT to screen for CRC in a general U.S. population.

Study Overview

• Status: Completed
• Conditions: Colorectal Cancer
• Intervention / Treatment: Behavioral: 1 FIT kit; Behavioral: 2 FIT kit

• Study Type: Interventional
• Enrollment (Actual): 2761
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• United States
  • Oregon
    • Portland, Oregon, United States, 97227
      • Kaiser Permanente Center for Health Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Eligible for standard KPNW automated telephonic colorectal cancer screening reminder and have indicated on the call that they wish to screen with FIT.

Exclusion Criteria:

• Kaiser Permanente members less than 1 year.
• Currently on the Kaiser Permanente Center for Health Research Do Not Call list.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 1 FIT kit	Behavioral: 1 FIT kit; Patient receives 1 FIT
Active Comparator: 2 FIT kit	Behavioral: 2 FIT kit; Patient receives 2 FIT kits

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
FIT Kit adherence	Among KPNW members aged 50-75 who are at average risk for colorectal cancer (CRC) and who are due for CRC screening, we propose to compare patient adherence to completion of a 1-FIT versus a 1-2 FIT protocol.	Year 2 of study

Collaborators and Investigators

• Sponsor: Kaiser Permanente
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Elizabeth G Liles, MD, Kaiser Foundation Hospital

Study record dates

Study Major Dates

• Study Start: August 1, 2012
• Primary Completion (Actual): April 1, 2016
• Study Completion (Actual): April 1, 2016

Study Registration Dates

• First Submitted: July 2, 2012
• First Submitted That Met QC Criteria: July 5, 2012
• First Posted (Estimate): July 6, 2012

Study Record Updates

• Last Update Posted (Estimate): September 16, 2016
• Last Update Submitted That Met QC Criteria: September 14, 2016
• Last Verified: September 1, 2016

More Information

Terms related to this study

• Keywords: Cancer; Screening; FIT; Colon; Fecal; Rectal
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms
• Other Study ID Numbers: 5R01CA154982 (U.S. NIH Grant/Contract); 1R01CA154982 (U.S. NIH Grant/Contract)