Health Literacy Interventions to Overcome Disparities in CRC Screening



Status:Active, not recruiting
Conditions:Colorectal Cancer, Colorectal Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:50 - 75
Updated:4/17/2018
Start Date:February 2015
End Date:December 2018

Use our guide to learn which trials are right for you!

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.

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 racial/ethnic 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.

Inclusion Criteria:

1. a patient of the identified clinics,

2. age 50 to 75 (based on American Cancer Society (ACS) guidelines), and

3. can speak and understand English

Exclusion Criteria:

1. previous history of cancer other than non-melanoma skin cancer,

2. up-to-date with CRC screening according to ACS guidelines (FOBT every year,
sigmoidoscopy every 5 years, or colonoscopy every 10 years),

3. a first relative family history that requires a more complete history and possible
colonoscopy because of their risk factor (these patients will be referred to their
provider for follow-up),

4. an uncorrectable hearing or visual impairment, or

5. too ill to participate.
We found this trial at
1
site
Shreveport, Louisiana
Principal Investigator: Connie L Arnold, PhD
Phone: 318-675-7013
?
mi
from
Shreveport, LA
Click here to add this to my saved trials