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

NCT02272244 | Completed Results

• 2 other identifiers: AD-1306-01882JT 5992
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

Colorectal Cancer

Keywords

Colorectal Cancer; Cancer Screening; Decision Support; Navigation

Outcome Measures

Primary Outcomes (1)

• Overall Screening Adherence

  The two study groups will be compared in terms of the fraction of participants who undergo CRC screening (through SBT, colonoscopy, flexible sigmoidoscopy, etc.) within 12 months of the randomization date. Screening will be measured using data from the 6-month survey and the 12-month chart audit.

  12 months

Secondary Outcomes (3)

• Change in Screening Decision Stage

  6 months

• Test Specific Screening Adherence

  12 Months

• Screening Knowledge and Perceptions

  6 months

Study Arms (2)

Standard

ACTIVE COMPARATOR

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.

Behavioral: Standard

Decision Support & Navigation

EXPERIMENTAL

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.

Behavioral: Decision Support & Navigation

Interventions

Decision Support & Navigation BEHAVIORAL

Decision Support & Navigation

Standard BEHAVIORAL

Standard

Eligibility Criteria

• Age: 50 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Thomas Jefferson University: lead
• Lehigh Valley Hospital: collaborator
• Fox Chase Cancer Center: collaborator
• Patient-Centered Outcomes Research Institute: collaborator

Study Sites (3)

Lehigh Valley Hospital

Allentown, Pennsylvania, 18105, United States

Location

Fox Chase Cancer Center

Philadelphia, Pennsylvania, 19012, United States

Location

Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States

Location

Related Publications (1)

• Myers RE, Stello B, Daskalakis C, Sifri R, Gonzalez ET, DiCarlo M, Johnson MB, Hegarty SE, Shaak K, Rivera A, Gordils-Molina L, Petrich A, Careyva B, de-Ortiz R, Diaz L. Decision Support and Navigation to Increase Colorectal Cancer Screening Among Hispanic Patients. Cancer Epidemiol Biomarkers Prev. 2019 Feb;28(2):384-391. doi: 10.1158/1055-9965.EPI-18-0260. Epub 2018 Oct 17.

  PMID: 30333221 DERIVED

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Results Point of Contact

• Title: Ronald Myers(Priniciple Investigator)
• Organization: Thomas Jefferson Universiy

ronald.myers@jefferson.edu

215-5034085

Study Officials

• Ronald E Myers, PhD

  Thomas Jefferson University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 20, 2014
• First Posted: October 22, 2014
• Study Start: October 1, 2014
• Primary Completion: January 20, 2017
• Study Completion: March 31, 2017
• Last Updated: May 4, 2025
• Results First Posted: August 12, 2019

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)