Ignite Creation Date:
2024-05-06 @ 3:44 AM
Last Modification Date:
2024-10-26 @ 11:38 AM
Study NCT ID:
NCT02360605
Status:
COMPLETED
Last Update Posted:
2021-06-30
First Post:
2015-02-05
Brief Title:
Health Literacy Interventions to Overcome Disparities in CRC Screening
Sponsor:
Louisiana State University Health Sciences Center Shreveport
Organization:
Louisiana State University Health Sciences Center Shreveport
Study Overview
Official Title:
Health Literacy Interventions to Overcome Disparities in CRC Screening
Status:
COMPLETED
Status Verified Date:
2021-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
In the proposed project the investigators will evaluate two different follow-up approaches to improve low income patients completion of initial and annual colorectal cancer CRC screening using the Fecal Immunochemical Test FIT the most sensitive FOBT The purpose of this study is to compare the effectiveness of two distinct follow-up strategies to promote CRC screening a prevention coordinator PC approach vs an automated telephone reminder ATR system The investigators will adapt a successful intervention tested in the Health Literacy and Cancer Screening Project by adding a follow-up strategy to the health literacy intervention Specific Aims The investigators Primary Aims are to 1 Compare the effectiveness of the PC and ATR strategies to improve initial and repeat CRC screening 2 Compare the cost effectiveness of the PC and ATR strategies for initial and repeat CRC screening The investigators Secondary Aims are to 3 Conduct a process evaluation of both follow-up strategies to investigate implementation and barriers 4 Determine if the effects of either strategy vary by patients literacy skills 5 Explore patient characteristics associated with CRC screening knowledge beliefs self-efficacy and compliance over time between study arms
Detailed Description:
The investigators objective is to compare the effectiveness of two distinct follow-up strategies to promote colorectal cancer screening a prevention coordinator PC approach vs an automated telephone reminder ATR system The investigators will adapt a successful intervention tested in the Health Literacy and Cancer Screening Project R01CA115869 by adding a follow-up strategy to the health literacy intervention In the proposed project the investigators will evaluate two different follow-up approaches to improve low income patients completion of initial and annual CRC screening using Fecal Immunochemical Test FIT
Substantial evidence shows that routine screening can prevent colorectal cancer CRC or detect it at an early stage reducing related mortality While overall CRC screening rates in the US are increasing rates remain persistently low among uninsured and low-income individuals those with fewer years of education and racialethnic minorities Low health literacy has been linked to cancer screening noncompliance higher rates of advanced stage of presentation of disease and health disparities In response the Department of Health and Human Services has called for health information and services that are accurate accessible and actionable as well as culturally appropriate
This study will implement a two-arm randomized controlled trial with low income underinsured patients in federally qualified health centers FQHCs to evaluate and compare the effectiveness of PC and ATR follow-up strategies to increase CRC screening All patients recruited to the study will receive evidence-based literacy appropriate screening materials developed using health literacy best practices and a simplified FIT kit Use of these materials has been shown to significantly increase CRC screening rates in the investigators ongoing study Patients will be randomized to receive either 1 the PC follow-up strategy in which a PC personally reminds patients to complete and mail FIT kits and perceived barriers to screening are discussed and addressed or 2 the ATR follow-up strategy in which an automated system electronically encourages patients to complete and mail FIT kits using plain language messages The effectiveness of these two approaches will be compared at 12 and 24 months
Substantial evidence shows that routine screening can prevent colorectal cancer CRC or detect it at an early stage reducing related mortality While overall CRC screening rates in the US are increasing rates remain persistently low among uninsured and low-income individuals those with fewer years of education and racialethnic minorities Low health literacy has been linked to cancer screening noncompliance higher rates of advanced stage of presentation of disease and health disparities In response the Department of Health and Human Services has called for health information and services that are accurate accessible and actionable as well as culturally appropriate
This study will implement a two-arm randomized controlled trial with low income underinsured patients in federally qualified health centers FQHCs to evaluate and compare the effectiveness of PC and ATR follow-up strategies to increase CRC screening All patients recruited to the study will receive evidence-based literacy appropriate screening materials developed using health literacy best practices and a simplified FIT kit Use of these materials has been shown to significantly increase CRC screening rates in the investigators ongoing study Patients will be randomized to receive either 1 the PC follow-up strategy in which a PC personally reminds patients to complete and mail FIT kits and perceived barriers to screening are discussed and addressed or 2 the ATR follow-up strategy in which an automated system electronically encourages patients to complete and mail FIT kits using plain language messages The effectiveness of these two approaches will be compared at 12 and 24 months
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| RSG-13-021-01 - CPPB | OTHER_GRANT | American Cancer Society | None |