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Low-Literacy Physician-Patient Intervention Promoting Colorectal Cancer Screening

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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:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Kenzie Cameron, Northwestern University

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 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

Resource links provided by the National Library of Medicine


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




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



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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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
National Cancer Institute (NCI)
Investigators
Principal Investigator: Kenzie A Cameron, PhD Northwestern University

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Kenzie Cameron, Research Associate Professor, Northwestern University
ClinicalTrials.gov Identifier: NCT01103479     History of Changes
Other Study ID Numbers: R01CA140177-01 ( U.S. NIH Grant/Contract )
R01CA140177 ( U.S. NIH Grant/Contract )
First Posted: April 14, 2010    Key Record Dates
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