Effect of Mailed Invites of Choice of Colonoscopy or FIT vs. Mailed FIT Alone on Colorectal Cancer Screening
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- 10000
Summary
- Conditions
- Colorectal Cancer
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: Evaluate effect of offering choice of FIT or colonoscopy (n=2,000) compared to FIT alone (n=8,000) on one-time CRC screening completion, repeat screening, and follow-up of abnormal FIT results.Masking: Single (Outcomes Assessor)Masking Description: Single BlindPrimary Purpose: Screening
Participation Requirements
- Age
- Between 50 years and 63 years
- Gender
- Both males and females
Description
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 ...
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.
Tracking Information
- NCT #
- NCT03414125
- Collaborators
- Cancer Prevention Research Institute of Texas
- Parkland Health and Hospital System
- Investigators
- Principal Investigator: Amit Singal, MD, MS UT Southwestern Medical Center