CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 5,970 enrolled
Drug / intervention
Mailed invitations for FIT test kits +2 moreother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01191411
NCT01191411N/ACompleted

Increasing Colorectal Cancer Screening in a Safety-net Health System With a Focus on the Uninsured: Benefits and Costs.

University of Texas Southwestern Medical Center·interventional·Posted Aug 30, 2010·Updated May 23, 2017

In Brief

A clinical study evaluating Mailed invitations for FIT test kits, Mailed invitations for a colonoscopy, and 1 other intervention for Colorectal Cancer. Completed, enrolled 5,970 participants.

Detailed Summary

Colon cancer (CRC) is a leading cause of cancer death in the United States. Screening can prevent CRC death, but screening rates are suboptimal, especially for vulnerable populations such as those with limited or no health insurance. This striking public health challenge demands urgent implementation of evidence-based strategies to reduce avoidable CRC death. Prior research has shown that a direct-to-consumer strategy of inviting patients by mail to complete CRC screening may result in increased rates of screening completion. However, this approach has not been tested extensively in vulnerable populations, such as the under/uninsured, and minority populations often cared for by safety-net health systems. Further, it is unclear whether patients are more likely to participate in one CRC screening test versus another. Knowing this is important to designing programs for increasing screening. For example, the planning and resources required for a screening program with colonoscopy--which is a sensitive but invasive and expensive test--are very different from a program with that uses stool testing to detect microscopic blood such as an immunochemical stool blood test--which is a less sensitive, but non-invasive and cheap test. Also, it is possible designing a program with a less sensitive, but more acceptable test could prevent more CRC death if participation in screening is test specific. For example, if many more patients participate in an immunochemical stool blood test based program than a colonoscopy based program, even though the immunochemical stool blood test is less sensitive, the program may save more lives because more patients are reached. The aims of this trial are to: Aim 1. Deliver CRC screening services (mailed invitation to screening, telephone reminders, and systematic clinical follow up) to uninsured, unscreened patients cared for by the safety-net health system serving Tarrant County, Texas. Patients will be invited to either: 1. Complete a free home-based, non-invasive immunochemical stool blood test 2. Complete a free colonoscopy Aim 2. Evaluate program outcomes, including screening rates, cancers detected, and program costs. The primary outcome is screening completion.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
Countries--

Timeline

N/ACompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedAug 30, 2010
Enrollment StartOct 1, 2010
Primary CompletionSep 1, 2013
TodayJul 2, 2026
Enrollment to primary: 2.9 yearsPosted 15.8 years ago

Interventions

Mailed invitations for FIT test kitsother

Mailed invitations for the non-invasive immunochemical stool blood test will be the intervention compared to the standard care at John Peter Smith Hospital. Patients will be invited to complete a free home-based, non-invasive immunochemical stool blood test.

Mailed invitations for a colonoscopyother

These patients will be mailed invitations to directly book a free colonoscopy, or to see a physician for free pre-operative screening at John Peter Smith Hospital.

Visit Based Careother

Visit based standard care at John Peter Smith Hospital. Patients will continue to see their regular physician and follow the physician's recommendations as they normally would.