N/A N=620 Randomized Prevention

Health Literacy Interventions to Overcome Disparities in CRC Screening

Colorectal Cancer

Bottom Line

View on ClinicalTrials.gov: NCT02360605 ↗

Enrolled (actual)

620

Serious AEs

0.0%

Results posted

Jun 2021

Primary outcome: Primary: Initial CRC Screening — 213; 205 Participants — p=0.61

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: automated telephone reminder (Behavioral); prevention coordinator (Behavioral); Health literacy appropriate education and demonstration (Behavioral)
Age: Adult, Older Adult · 50+ yrs
Sex: All
Sponsor: Louisiana State University Health Sciences Center Shreveport
Primary completion: Nov 2018

Outcome Measures

Outcome	Result	p-value
PRIMARY Initial CRC Screening	213; 205	0.61
PRIMARY Repeat CRC Screening	104; 95	0.30
PRIMARY Repeat Screening	58; 58	0.97

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.

Eligibility Criteria

Inclusion Criteria

a patient of the identified clinics,
age 50 to 75 (based on American Cancer Society (ACS) guidelines), and
can speak and understand English

Exclusion Criteria

previous history of cancer other than non-melanoma skin cancer,
up-to-date with CRC screening according to ACS guidelines (FOBT every year, sigmoidoscopy every 5 years, or colonoscopy every 10 years),
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),
an uncorrectable hearing or visual impairment, or
too ill to participate.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02360605). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.