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Low-Literacy Physician-Patient Intervention Promoting Colorectal Cancer Screening

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Kenzie Cameron, Northwestern University
ClinicalTrials.gov Identifier:
NCT01103479
First received: April 12, 2010
Last updated: April 4, 2013
Last verified: April 2013
History of Changes
  Purpose

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 Intervention Phase
Colorectal Cancer
 Behavioral: Physician Intervention
Behavioral: Physician and Patient Intervention
 Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Health Services Research
Official Title: Low-Literacy Physician-Patient Intervention Promoting Colorectal Cancer Screening

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Northwestern University:

Primary Outcome Measures:
  • Provider recommendation of CRC screening and patient CRC screening completion rates [ Time Frame: 6 months following patient enrollment in study ] [ Designated as safety issue: No ]
    Primary outcome measure is provider recommendation of CRC screening and patient CRC screening completion rates at 6 months following patient enrollment in the study.


Secondary Outcome Measures:
  • Patient increases in knowledge and personal perception of risk regarding CRC and CRC screening. [ Time Frame: Day of enrollment in study (pre/post measurement) ] [ Designated as safety issue: No ]
    Secondary outcomes of this study are patient increases in knowledge and personal perception of risk regarding CRC and CRC screening. This will be assessed by a pre/post test interview with the patient before their provider appointment and immediately after they see their provider at the health center.


Estimated Enrollment: 900
Study Start Date: April 2010
Estimated Study Completion Date: July 2013
Estimated Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Control
Participants will complete interviewer-administered pre- and post-test
Experimental: Physician Training
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

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.

  Eligibility

Ages Eligible for Study:   50 Years to 75 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01103479

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
Investigators
Principal Investigator: Kenzie A Cameron, PhD Northwestern University
  More Information

No publications provided

Responsible Party: Kenzie Cameron, Research Associate Professor, Northwestern University
ClinicalTrials.gov Identifier: NCT01103479     History of Changes
Other Study ID Numbers: R01-CA140177-01
Study First Received: April 12, 2010
Last Updated: April 4, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by 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

ClinicalTrials.gov processed this record on June 18, 2013