Effect of Mailed Invites of Choice of Colonoscopy or FIT vs. Mailed FIT Alone on Colorectal Cancer Screening

Summary

This is a pragmatic, randomized, controlled trial comparing whether a mailed outreach intervention offering patients who are not up-to-date with colorectal cancer (CRC) a choice of completing a home Fecal Immunochemical Test (FIT) test or scheduling a screening colonoscopy increases CRC screening completion compared to a mailed FIT kit outreach program (which does not offer an explicit choice of screening modality). The trial will be conducted in a racially and socioeconomically diverse cohort of patients served by an integrated safety net delivery system that has a "FIT first" population health screening strategy. All patients will also have access to whatever CRC screening is recommended through usual visit-based care.

Conditions

• Colorectal Cancer

Interventions

OTHER

FIT Screening Strategy

Mailed outreach invitation to complete FIT. FIT Strategy invitation includes: 1) invitation letter, 2) test kit (1-sample FIT, simplified instructions on how to perform the test and return mailer with prepaid postage). Up to three "live" phone reminders from project staff 2 to 3 weeks after the invitation to encourage screening completion. Centralized processes to promote guideline-based follow-up.

OTHER

Choice Screening Strategy

Mailed outreach invitation offering patients the choice to complete either a FIT or schedule a colonoscopy. Letter will discuss advantages and disadvantages of FIT vs. colonoscopy but will not recommend a particular test, allowing patients to choose a screening option based on their own preferences. Outreach includes: 1) invitation letter, 2) choice grid 3) telephone number for scheduling colonoscopy, and 4) test kit (1-sample FIT, simplified instructions on how to perform the test and return mailer with prepaid postage). Up to three "live" phone call reminders from project staff 2 to 3 weeks after the mailed invitation to encourage screening completion. Centralized processes to promote guideline-based follow-up.

Sponsors & Collaborators

• Cancer Prevention Research Institute of Texas

  collaborator OTHER

• Parkland Health and Hospital System

  collaborator OTHER

• University of Texas Southwestern Medical Center

  lead OTHER

Principal Investigators

• Amit Singal, MD, MS · UT Southwestern Medical Center

Study Design

Allocation

RANDOMIZED

Purpose

SCREENING

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

50 Years

Max Age

63 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2018-09-07

Primary Completion

2021-08-31

Completion

2021-08-31

Countries

• United States

Study Locations