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

Colorectal cancer (CRC) is the 2nd leading cause of cancer death in the US, though CRC

death can be reduced by screening. In the NCI-funded UT Southwestern-Parkland PROSPR

Center (U54 CA163308), mailed FIT-based outreach doubled the proportion of patients

up-to-date with screening compared to usual care. Investigators are now conducting a

comparative effectiveness trial to evaluate the effect of a mailed invite offering a

choice of FIT or colonoscopy (n=2,000) on one-time CRC screening completion compared to

mailed FIT-based outreach (which does not offer an explicit choice of screening modality

(n=8,000.) Randomization will be stratified based on whether or not patients completed a

FIT within the prior 18-month period. Patients randomized to FIT outreach will receive:

a) low-literacy educational letters, b) mailed screening outreach invitations, c) a

one-sample home FIT kit and return mailer with prepaid postage, d) telephone reminder

calls including one-on-one education, and e) centralized patient navigation for follow-up

of abnormal screening results, and treatment for patients newly diagnosed with CRC.

Patients randomized to the "choice" arm will receive the same materials described above;

however, the educational letter will explain and offer the additional choice of screening

by colonoscopy (instead of completing the mailed FIT kit). The mailing will include a low

health literacy one-page option grid outlining the pros and cons of FIT vs. colonoscopy.

We will not recommend a particular test as preferred but instead emphasize that both are

good choices, and the patient should choose the screening option that seems right for

them. Patients choosing colonoscopy will be provided a telephone number to schedule the

procedure. During scheduling, patients will be triaged by study staff with a structured

history and physical form to "direct access" colonoscopy or a pre-colonoscopy clinic

visit. Patients choosing FIT can return the one-sample mailed FIT kit using the return

envelope with prepaid postage.