Clinical trial NCT03414125: Effect of Mailed Invites of Choice of Colonoscopy or FIT vs. Mailed FIT Alone on Colorectal Cancer Screening
Official title: Comparing the Effect of a Mailed Outreach Intervention Offering Choice of Colonoscopy or FIT vs. Mailed FIT Alone on Colorectal Cancer Screening Outcomes: A Pragmatic Randomized Control Trial in a Safety Net Health System
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colorectal Cancer
Keywords: Colorectal Cancer
Colon Cancer
FIT Screening Strategy
Colon Screening Strategy
Colorectal Neoplasms
Mass Screening
Health Services Research
Comparative Effectiveness Research
Lead sponsor: University of Texas Southwestern Medical Center
Sponsor class: OTHER
Collaborators: name: Cancer Prevention Research Institute of Texas
name: Parkland Health and Hospital System
First posted: 2018-01-29
Enrollment: 26859
Sex: ALL
Minimum age (years): 50
Maximum age (years): 63
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: SCREENING

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.

Eligibility criteria: 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

Primary outcomes:
measure: One-time Screening Completion
timeFrame: Within one year of randomization
Secondary outcomes:
measure: Screening Up-to-date
timeFrame: At 2 and 3 years post-randomization
measure: Choice of FIT versus Colonoscopy
timeFrame: Within 6 months of invitation
Other outcomes:
Locations:
city: Dallas
country: United States
facility: Parkland Health & Hospital System
state: Texas
Study officials:
affiliation: UT Southwestern Medical Center
name: Amit Singal, MD, MS
role: PRINCIPAL_INVESTIGATOR
References: