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

NCT ID: NCT03414125

Last Updated: 2021-09-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 26859 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-09-07
• Study Completion Date: 2021-08-31

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.

Conditions

Colorectal Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SCREENING
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

FIT Screening Strategy

Intervention Type: OTHER

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.

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.

Choice Strategy outreach invitation includes: 1) invitation letter, 2) option grid comparing FIT and colonoscopy 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.

Group Type: EXPERIMENTAL

Choice Screening Strategy

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: OTHER

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

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 63 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cancer Prevention Research Institute of Texas

OTHER

Sponsor Role: collaborator

Parkland Health and Hospital System

OTHER

Sponsor Role: collaborator

University of Texas Southwestern Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Amit Singal

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Amit Singal, MD, MS

Role: PRINCIPAL_INVESTIGATOR

UT Southwestern Medical Center

Locations

Parkland Health & Hospital System

Dallas, Texas, United States

Countries

United States

Other Identifiers

21985

Identifier Type: OTHER

Identifier Source: secondary_id

PP160075

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

STU 082016-060

Identifier Type: -

Identifier Source: org_study_id