Low-Literacy Physician-Patient Intervention Promoting Colorectal Cancer Screening

• ClinicalTrials.gov Identifier: NCT01103479
• Recruitment Status: Completed
• First Posted: April 14, 2010
• Results First Posted: September 9, 2014
• Last Update Posted: May 6, 2015
• Sponsor: Northwestern University
• Collaborator: National Cancer Institute (NCI)
• Information provided by (Responsible Party): Kenzie Cameron, Northwestern University

Study Description

Brief Summary:

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.

Condition or disease	Intervention/treatment	Phase
Colorectal Cancer	Behavioral: Physician Intervention; Behavioral: Physician and Patient Intervention	Phase 2; Phase 3

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 569 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Health Services Research
• Official Title: Low-Literacy Physician-Patient Intervention Promoting Colorectal Cancer Screening
• Study Start Date: April 2010
• Actual Primary Completion Date: July 2013
• Actual Study Completion Date: September 2013

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

1. Colorectal Cancer (CRC) Screening Completion [ Time Frame: within 6 months of provider recommendation ]
   CRC screening completion via Fecal Occult Blood Test (FOBT), Fecal Immunochemical Test (FIT) or Colonoscopy
2. Colorectal Cancer (CRC) Screening Completion [ Time Frame: within 6 months of provider recommendation ]
   CRC screening completion via FOBT, FIT or Colonoscopy

Secondary Outcome Measures :

1. Provider Recommendation of CRC Screening [ Time Frame: 6 months following patient enrollment into study ]
   Provider recommendation of CRC Screening based on chart review

Eligibility Criteria

• Ages Eligible for Study: 50 Years to 75 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

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)

Contacts and Locations

Locations

United States, Illinois

Access Community Health Network

Chicago, Illinois, United States, 60606

University of Illinois Hospital & Health Sciences System

Chicago, Illinois, United States, 60612

Sponsors and Collaborators

Northwestern University

National Cancer Institute (NCI)

Investigators

• Principal Investigator: Kenzie A Cameron, PhD; Northwestern University

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Kenzie Cameron, Research Associate Professor, Northwestern University
• ClinicalTrials.gov Identifier: NCT01103479
• Other Study ID Numbers: R01CA140177-01 ( U.S. NIH Grant/Contract ); R01CA140177 ( U.S. NIH Grant/Contract )
• First Posted: April 14, 2010
• Results First Posted: September 9, 2014
• Last Update Posted: May 6, 2015
• Last Verified: April 2015

Keywords provided by Kenzie Cameron, Northwestern University:

Early Detection of Cancer; Colorectal Cancer Screening

Additional relevant MeSH terms:

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