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Low Literacy Intervention for Colorectal Cancer Screening
This study has been completed.
First Received: March 14, 2001   Last Updated: August 6, 2009   History of Changes
Sponsor: Department of Veterans Affairs
Information provided by: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00012922
  Purpose

Of 17 performance measures of hospital quality regularly reported for the Veterans Administration (VA) health care system, rates of colorectal cancer screening are the lowest.


Condition Intervention
Colorectal Cancer
Behavioral: Low Literacy Intervention for Colorectal Cancer Screening

Study Type: Interventional
Study Design: Randomized, Open Label, Active Control, Single Group Assignment, Efficacy Study
Official Title: Low Literacy Intervention for Colorectal Cancer Screening

Resource links provided by NLM:


Further study details as provided by Department of Veterans Affairs:

Estimated Enrollment: 2400
Study Completion Date: April 2003
Arms Assigned Interventions
1 Behavioral: Low Literacy Intervention for Colorectal Cancer Screening

Detailed Description:

Background:

Of 17 performance measures of hospital quality regularly reported for the Veterans Administration (VA) health care system, rates of colorectal cancer screening are the lowest.

Objectives:

The objectives of this study were to 1) test whether a health care provider-directed intervention increased colorectal cancer screening rates in an urban VA medical center and 2) evaluate the cost-effectiveness of the intervention.

Methods:

The study was a randomized controlled trial, conducted at two clinic firms at a VA Medical Center in Chicago. Eligible patients were men, age 50 and older, had no personal or family history of colorectal cancer or polyps, had not received colorectal cancer screening, and had at least one visit to the clinic during the study period. Health care providers in the intervention firm attended a workshop on colorectal cancer screening. Every 4-6 months they attended quality improvement workshops where they received group screening rates, individualized confidential feedback, and training on improving communication with patients with limited literacy skills. Medical records were reviewed for colorectal cancer screening recommendations and completion. Literacy level was assessed in a subset of patients. In the cost-effectiveness analysis, resource and cost estimates were derived.

Status:

The project is complete.

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

Patients over 50 with average risk for colorectal cancer. Patients with family history and/or personal history excluded, as well as those up to date on colorectal cancer screening.

Exclusion Criteria:

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00012922

Locations
United States, Illinois
Jesse Brown VAMC (WestSide Division)
Chicago, Illinois, United States, 60612
Sponsors and Collaborators
Investigators
Principal Investigator: Charles L. Bennett, MD PhD MPP Jesse Brown VAMC (WestSide Division)
  More Information

Publications:
Davis TC, Dolan NC, Ferreira MR, Tomori C, Green KW, Sipler AM, Bennett CL. The role of inadequate health literacy skills in colorectal cancer screening. Cancer Invest. 2001;19(2):193-200. Review.
Golub RM, Bennett CL, Stinson T, Venta L, Morrow M. Cost minimization study of image-guided core biopsy versus surgical excisional biopsy for women with abnormal mammograms. J Clin Oncol. 2004 Jun 15;22(12):2430-7.
Ferreira MR, Dolan NC, Fitzgibbon M, Newlin R, Davis TC, Rademaker A, Schmitt B, Medio F, Bennet CL. An Intervention to Increase Colorectal Cancer Screening Among Veterans: Rationale and Study Design. International Journal of Cancer Prevention. 2004 Jul 1; 1:369-381.
Wolf MS, Bennett CL. Local perspective of the impact of the HIPAA privacy rule on research. Cancer. 2006 Jan 15;106(2):474-9.
Dolan NC, Ferreira MR, Davis TC, Fitzgibbon ML, Rademaker A, Liu D, Schmitt BP, Gorby N, Wolf M, Bennett CL. Colorectal cancer screening knowledge, attitudes, and beliefs among veterans: does literacy make a difference? J Clin Oncol. 2004 Jul 1;22(13):2617-22.
Ferreira MR, Dolan NC, Fitzgibbon ML, Davis TC, Gorby N, Ladewski L, Liu D, Rademaker AW, Medio F, Schmitt BP, Bennett CL. Health care provider-directed intervention to increase colorectal cancer screening among veterans: results of a randomized controlled trial. J Clin Oncol. 2005 Mar 1;23(7):1548-54.
Wolf MS, Rademaker A, Bennett CL, Ferreira MR, Dolan NC, Davis TC, Medio F, Liu D, Lee J, Fitzgibbon M. Development of a brief survey on colon cancer screening knowledge and attitudes among veterans. Prev Chronic Dis. 2005 Apr;2(2):A11. Epub 2005 Mar 15.
Dolan NC, Ferreira MR, Fitzgibbon ML, Davis TC, Rademaker AW, Liu D, Lee J, Wolf M, Schmitt BP, Bennett CL. Colorectal cancer screening among African-American and white male veterans. Am J Prev Med. 2005 Jun;28(5):479-82.
Fitzgibbon ML, Ferreira MR, Dolan NC, Davis TC, Rademaker AW, Wolf MS, Dachao Liu, Gorby N, Schmitt BP, Bennett CL. Process Evaluation in an Intervention Designed to Improve Rates of Colorectal Cancer Screening in a VA Medical Center. Health Promot Pract. 2007 Jul;8(3):273-81.

Responsible Party: Department of Veterans Affairs ( Bennett, Charles - Principal Investigator )
Study ID Numbers: PCI 99-158
Study First Received: March 14, 2001
Last Updated: August 6, 2009
ClinicalTrials.gov Identifier: NCT00012922     History of Changes
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Neoplasms
Digestive System Diseases
Neoplasms by Site
Digestive System Neoplasms
Gastrointestinal Diseases
Colonic Diseases
Gastrointestinal Neoplasms
Intestinal Diseases
Rectal Diseases
Intestinal Neoplasms
Colorectal Neoplasms

ClinicalTrials.gov processed this record on November 27, 2009