Colorectal Cancer
Conditions
Keywords
Colorectal Cancer, Colon Cancer, FIT Screening Strategy, Colon Screening Strategy, Colorectal Neoplasms, Mass Screening, Health Services Research, Comparative Effectiveness Research
Brief 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.
Detailed 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 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.
Interventions
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.
OTHERChoice 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
Cancer Prevention Research Institute of Texas
Parkland Health and Hospital System
University of Texas Southwestern Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
SINGLE (Outcomes Assessor)
Masking description
Single Blind
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
50 Years to 63 Years
Healthy volunteers
No
Inclusion criteria
* Males and females * Age 50-64 years * Seen at least one time at a Parkland primary care clinic within one year prior to randomization * Participants in Parkland's medical assistance program for the uninsured (Parkland Financial Assistance) * All races and ethnicities
Exclusion criteria
* Up-to-date with CRC screening, defined by: 1. Colonoscopy in the last 10 years 2. Sigmoidoscopy in the last 5 years * Prior history of CRC, total colectomy, inflammatory bowel disease, or colon polyps * Address or phone number not on file * Incarcerated
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| One-time Screening Completion | Within one year of randomization | Proportion of patients who complete CRC screening with colonoscopy, sigmoidoscopy, or FIT |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Screening Up-to-date | At 2 and 3 years post-randomization | Screening Up-to-date status |
| Choice of FIT versus Colonoscopy | Within 6 months of invitation | Proportion of patients who choose FIT versus colonoscopy |
Countries
United States
Outcome results
None listed