Evidence Based Colorectal Cancer Screening for the Uninsured - Sub-study

NCT ID: NCT02651974

Last Updated: 2020-02-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 8565 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-09-30
• Study Completion Date: 2017-04-30

Brief Summary

This is a sub-study nested within a previously initiated clinical study (# NCT01946282) focusing on individuals not previously randomized at baseline to the original interventions. The purpose of the sub-study is to evaluate, via a randomized controlled trial design, 3 strategies for promoting screening completion among individuals not up to date with colorectal cancer screening, but assigned to receive screening outreach.

Detailed Description

In the previously initiated, ongoing clinical study (# NCT01946282) investigators are testing a systematic colon cancer screening outreach strategy for increasing screening completion among uninsured patients, not up-to-date with screening. This is a Sub-study to #NCT01946282 (IRB # 082012-086).

Sub-study description:

The goal of the sub-study is to identify strategies that may further increase rates of 1) initial participation in colorectal cancer screening, and 2) follow up of abnormal colorectal cancer screening tests with colonoscopy.

At the time of the sub-study, all patients randomly assigned to receive gift card incentives have been enrolled. At this time only standard, non-incentive invitations continue to be mailed to eligible patients.

The sub-study involves 2 parts:

Part 1: Participants scheduled to receive mailed fecal immunochemical test (FIT) outreach for the first time late in the 2nd year of the study will be randomly assigned to receive one of three invitation letters, which vary slightly from one another.

For the sub-study, the standard invitation letter will be replaced with one of the three sub-study letters. All new participants will receive one of the 3 letters during 2 predetermined rounds of invitations (involving n=2,124 individuals). There will be 3 conditions for the sub-study letters and individuals will be randomly assigned 1:1:1 to each condition. The 3 conditions are as follows:

i) Condition 1 - control letter will be similar to the previous study letters with some slight wording and grammatical improvements, ii) Condition 2 - cost letter will be the control letter plus the addition of one sentence informing recipients of the average value of the FIT procedure and; iii) Condition 3 - cost/future letter will include the average value of FIT and a sentence assuring patients that should a follow-up test be requested, it will be provided free of charge.

Rationale and plan for sub-study Part 1: Over nearly 2 years of the program the investigators have tested a systematic outreach strategy for increasing screening completion among uninsured patients, not up to date with screening. Through these carefully evaluated interventions, the investigators have shown that an outreach invitation strategy, particularly when it includes FIT invitations, markedly increases screening completion among the uninsured. Thirty-six percent of individuals invited to complete FIT return the test. The investigators believe this rate may be improved by making changes to the invitation letters. The sub-study hypothesis is that providing information in the letter about the value of the kit and attenuating concern about future cost will further increase FIT and follow-up response rates.

Part 2: In part 2 of the sub-study, participants will receive their FIT results in either a white envelope (normal results, no immediate follow-up necessary) or a red envelope (abnormal result, need to follow-up with physician). The only change to this portion of the study is the color of the envelope patients receive.

Rationale and plan for Part 2: With the current program, the rate of follow-up diagnostic colonoscopy after abnormal FIT is 58%. Since individuals with abnormal FIT have an increased chance of having colorectal cancer, identifying alternate strategies to improve compliance with diagnostic colonoscopy is desirable. Accordingly the sub-study will employ a simple alerting tactic through the color of the envelope (red for abnormal and white for normal). The investigators hypothesize that more patients will follow-up after receiving a positive FIT result as a result of the messaging importance of abnormal tests with a red envelope. Because the sub-study will be employed in 2 predetermined rounds of invitations, investigators will have the opportunity to conduct a pre-post analysis of the follow-up rates to test this hypothesis.

Conditions

Colorectal Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: DOUBLE

Study Groups

Control condition

A control invitation letter similar to the previous standard (non-incentive) invitation with slight wording and grammatical improvements will be mailed to patients randomly assigned to this group.

Group Type: ACTIVE_COMPARATOR

Cost condition

Intervention Type: BEHAVIORAL

Patients will be mailed a cost condition invitation letter to complete a home fecal immunochemical test (FIT) for colorectal cancer screening.

Cost/Future condition

Intervention Type: BEHAVIORAL

Patients will be mailed a cost/future condition invitation letter to complete a home fecal immunochemical test (FIT) for colorectal cancer screening.

Cost condition

A control invitation letter with the addition of one line informing participants of the average value of the KIT procedure will be mailed to patients randomly assigned to this group.

Group Type: ACTIVE_COMPARATOR

Control condition

Intervention Type: BEHAVIORAL

Patients will be mailed a control invitation letter to complete a home fecal immunochemical test (FIT) for colorectal cancer screening.

Cost/Future condition

Intervention Type: BEHAVIORAL

Patients will be mailed a cost/future condition invitation letter to complete a home fecal immunochemical test (FIT) for colorectal cancer screening.

Cost/Future condition

An invitation letter with the average value of the KIT procedure and a sentence assuring participants that should a follow-up test be requested, it will also be provided free of charge will be mailed to patients randomly assigned to this group.

Group Type: ACTIVE_COMPARATOR

Control condition

Intervention Type: BEHAVIORAL

Patients will be mailed a control invitation letter to complete a home fecal immunochemical test (FIT) for colorectal cancer screening.

Cost condition

Intervention Type: BEHAVIORAL

Patients will be mailed a cost condition invitation letter to complete a home fecal immunochemical test (FIT) for colorectal cancer screening.

Interventions

Control condition

Patients will be mailed a control invitation letter to complete a home fecal immunochemical test (FIT) for colorectal cancer screening.

Intervention Type: BEHAVIORAL

Cost condition

Patients will be mailed a cost condition invitation letter to complete a home fecal immunochemical test (FIT) for colorectal cancer screening.

Intervention Type: BEHAVIORAL

Cost/Future condition

Patients will be mailed a cost/future condition invitation letter to complete a home fecal immunochemical test (FIT) for colorectal cancer screening.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Uninsured
• Participants in John Peter (JPS) Health System medical assistance program for the uninsured.
• One or more visits to a JPS primary care clinic within a year.
• Not up-to-date with colorectal cancer screening

Exclusion Criteria

• Patients with a history of colorectal cancer or colon resection
• No address and/or phone number on file with JPS
• Incarcerated

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 64 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cancer Prevention Research Institute of Texas

OTHER

Sponsor Role: collaborator

University of Texas Southwestern Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Keith E Argenbright, MD

Role: PRINCIPAL_INVESTIGATOR

University of Texas Southwestern Medical Center

Other Identifiers

082012-086 Sub-study

Identifier Type: -

Identifier Source: org_study_id