Increasing Colorectal Cancer (CRC) Screening Among Hispanic Primary Care Patients

Thomas Jefferson University

Status: Completed

Conditions: Colorectal Cancer

Treatments: Behavioral: Standard; Behavioral: Decision Support & Navigation

Study type: Interventional

Funder types: Other

Identifiers

NCT02272244

AD-1306-01882

JT 5992 (Other Identifier)

Details and patient eligibility

About

This study is designed to test a standard mailed intervention (SI) versus a novel decision support and navigation intervention (DSNI). Working with patients and stakeholders, this randomized trial will include 400 Hispanic men and women who are 50 to 75 years of age, patients in community based primary care practices, and are eligible for CRC screening. We will consent, survey, and randomize participants either to the SI Group (n=200) or the DSNI Group (n=200). Study specific aims are to: (1) Assess intervention (DSNI versus SI) impact on overall CRC screening adherence; (2)Assess intervention (DNSI versus SI) impact on CRC screening decision stage; (3) Assess intervention (DNSI versus SI) impact on test-specific CRC screening adherence; and (4) Assess intervention (DNSI versus SI) impact on CRC and knowledge and perceptions.

Enrollment: 400 patients

Sex: All

Ages: 50 to 75 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Male or Female
• Self-identifies as being Hispanic or Latino
• 50 to 75 years of age

Exclusion criteria

• Previous diagnosis of CRC
• Up to date with CRC screening guidelines.
• Personal history of inflammatory bowel disease
• Personal history of polyps
• Family history of CRC diagnosed before the age of 60 years

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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400 participants in 2 patient groups

Standard

Active Comparator group

Description:

SI Group participants will be mailed a set of standard materials. The materials will include a letter from the participant's primary care practice encouraging selection and performance of either (1) colonoscopy screening, or (2) stool blood test (SBT) screening. Accompanying the letter will be instructions for arranging a colonoscopy appointment and instructions for completing an enclosed immunochemical SBT kit. Print materials and contacts will be provided, in both English and Spanish, after the baseline survey. At 45 days following random assignment that encourages screening.

Treatment:

Behavioral: Standard

Decision Support & Navigation

Experimental group

Description:

DSNI Group will be mailed print materials, including a letter from the practice on CRC screening, an informational booklet, and instructions for arranging a colonoscopy appointment and for completing an enclosed immunochemical SBT kit. All materials will be provided in both English and Spanish. Within 7 days after this mailing, participants will receive a telephone call from a trained bilingual study navigator. Following the call, the navigator will enter the participant's screening plan into the participant's electronic medical record, send the participant a letter describing the screening plan, and send the participant's primary care provider a copy of that same letter. At 45 days following random assignment, research staff will send participants a reminder letter encouraging the participant's preferred test. At 6 months after randomization, the navigator will send the provider and their office manager a participant CRC screening status report.

Treatment:

Behavioral: Decision Support & Navigation