Low-Literacy Physician-Patient Intervention Promoting Colorectal Cancer Screening

The purpose of this study is to evaluate the effectiveness of a low literacy, physician and patient-directed intervention to promote colorectal cancer (CRC) screening among the medically underserved.

Study Overview

• Status: Completed
• Conditions: Colorectal Cancer
• Intervention / Treatment: Behavioral: Physician Intervention; Behavioral: Physician and Patient Intervention

Detailed Description

This study will test the separate and combined effect of two of these interventions: 1) a provider communication skills training using a continuous quality improvement (CQI) framework, and 2) a brief, multimedia Patient Education Program (PEP) that incorporates plain language, graphic design, and audio voice-over to overcome literacy limitations. Our provider intervention has demonstrated efficacy to significantly improve CRC screening recommendation rates. Our multimedia program has also been field tested among patients with limited literacy and was able to improve patient knowledge and intention to receive screening.

We will implement both provider-only and combined provider-patient strategies within a federally qualified health center network to determine the most effective and efficient approach to promote CRC screening in these settings. Results from the study, supplemented by cost analyses and the process evaluation will directly inform translational strategies for cancer prevention within difficult community-based healthcare settings.

• Study Type: Interventional
• Enrollment (Actual): 569
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60606
      • Access Community Health Network
    • Chicago, Illinois, United States, 60612
      • University of Illinois Hospital & Health Sciences System

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients aged 50-75 years of age (in month 1 of the study)
• Patients have had two or more visits to the clinic during the past two years
• ACCESS Community Health Network patients
• University of Illinois Hospital & Health Sciences System patients
• Patients ages 50 - 75 as of the start of the intervention study
• English or Spanish-Speaking

Exclusion Criteria:

• Patients <50 or > 75 years of age
• Patients who have had fewer than two or more visits to the clinic during the past two years
• Personal history of CRC or colorectal polyps, or of inflammatory bowel disease and a family history with a first-degree relative with CRC or colorectal polyps.
• Unable to speak English or Spanish
• Compliant with CRC screening (FOBT or FIT within the past year; flexible sigmoidoscopy within past 5 years; colonoscopy within past 10 years)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control; Participants will complete interviewer-administered pre- and post-test
Experimental: Physician Intervention; Physicians at these clinics will participate in 6 training sessions over the course of 3 1/2 years; training sessions relate to colorectal cancer screening guidelines, communication skills, and health literacy training	Behavioral: Physician Intervention; Physicians at these clinics will participate in 6 training sessions over the course of 3 1/2 years; training sessions relate to colorectal cancer (CRC) screening guidelines, communication skills, and health literacy training
Experimental: Physician and Patient Intervention; Physicians at these clinics will participate in 6 training sessions over the course of 3 1/2 years; training sessions relate to colorectal cancer (CRC) screening guidelines, communication skills, and health literacy training; patients in this condition will also view an educational digital video disc (DVD) on CRC and CRC screening	Behavioral: Physician and Patient Intervention; Physicians at these clinics will participate in 6 training sessions over the course of 3 1/2 years; training sessions relate to colorectal cancer (CRC) screening guidelines, communication skills, and health literacy training; patients in this condition will also view an educational DVD on CRC and CRC screening

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Colorectal Cancer (CRC) Screening Completion	CRC screening completion via Fecal Occult Blood Test (FOBT), Fecal Immunochemical Test (FIT) or Colonoscopy	within 6 months of provider recommendation
Colorectal Cancer (CRC) Screening Completion	CRC screening completion via FOBT, FIT or Colonoscopy	within 6 months of provider recommendation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Provider Recommendation of CRC Screening	Provider recommendation of CRC Screening based on chart review	6 months following patient enrollment into study

Collaborators and Investigators

• Sponsor: Northwestern University
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Kenzie A Cameron, PhD, Northwestern University

Publications and helpful links

General Publications

• Cameron KA, Ramirez-Zohfeld V, Ferreira MR, Dolan NC, Radosta J, Galanter WL, Eder MM, Wolf MS, Rademaker AW. The Effects of a Multicomponent Colorectal Cancer Screening Intervention on Knowledge, Recommendation, and Screening among Underserved Populations. J Health Care Poor Underserved. 2020;31(4):1612-1633. doi: 10.1353/hpu.2020.0122.
• Ramirez-Zohfeld V, Rademaker AW, Dolan NC, Ferreira MR, Eder MM, Liu D, Wolf MS, Cameron KA. Comparing the Performance of the S-TOFHLA and NVS Among and Between English and Spanish Speakers. J Health Commun. 2015;20(12):1458-64. doi: 10.1080/10810730.2015.1018629. Epub 2015 Jul 6.
• Dolan NC, Ramirez-Zohfeld V, Rademaker AW, Ferreira MR, Galanter WL, Radosta J, Eder MM, Cameron KA. The Effectiveness of a Physician-Only and Physician-Patient Intervention on Colorectal Cancer Screening Discussions Between Providers and African American and Latino Patients. J Gen Intern Med. 2015 Dec;30(12):1780-7. doi: 10.1007/s11606-015-3381-8. Epub 2015 May 19.

Study record dates

Study Major Dates

• Study Start: April 1, 2010
• Primary Completion (Actual): July 1, 2013
• Study Completion (Actual): September 1, 2013

Study Registration Dates

• First Submitted: April 12, 2010
• First Submitted That Met QC Criteria: April 13, 2010
• First Posted (Estimate): April 14, 2010

Study Record Updates

• Last Update Posted (Estimate): May 6, 2015
• Last Update Submitted That Met QC Criteria: April 14, 2015
• Last Verified: April 1, 2015

More Information

Terms related to this study

• Keywords: Early Detection of Cancer; Colorectal Cancer Screening
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms
• Other Study ID Numbers: R01CA140177-01 (U.S. NIH Grant/Contract); R01CA140177 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No