Clinical trial NCT02360605: Health Literacy Interventions to Overcome Disparities in CRC Screening
Official title: Health Literacy Interventions to Overcome Disparities in CRC Screening
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colorectal Cancer
Keywords: colorectal cancer screening
low literacy
community clinics
Fecal Immunochemical Test
Lead sponsor: Louisiana State University Health Sciences Center Shreveport
Sponsor class: OTHER
Collaborators: name: Northwestern University
name: Loyola University
First posted: 2015-02-10
Enrollment: 620
Sex: ALL
Minimum age (years): 50
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Initial CRC Screening
timeFrame: 6 months after receipt of FIT kit
measure: Repeat CRC Screening
timeFrame: between 12 and 18 months of previous screen, 2 years overall
measure: Repeat Screening
timeFrame: between 12 and 18 months of previous screen, 2 years overall
Secondary outcomes:
Other outcomes:
Locations:
city: Shreveport
country: United States
facility: LSU Health Sciences Center
state: Louisiana
Study officials:
References:
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