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Randomized Clinical Trial to Improve Colon Cancer Screening in Poor Rural Iowa Counties

52 Years
79 Years
Open (Enrolling)
Colorectal Cancer

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Trial Information

Randomized Clinical Trial to Improve Colon Cancer Screening in Poor Rural Iowa Counties

Colorectal cancer is the second leading cause of cancer death in the U.S. yet approximately
half of eligible adults are not up-to-date with colon cancer screening and the rates of
screening are lower among those with lower incomes and who lack insurance. A physician's
recommendation for screening has consistently been show to be one of the most powerful
predictors of CRC screening. Relatively few studies of CRC screening have been conducted in
primary care. Disparities in CRC screening rates are seen in low socioeconomic and rural
individuals who often lack resources and access to screening. Most intervention studies have
been conducted in managed care settings, community health centers, Veteran's Administration
or academic practices. Few studies have looked at interventions in rural medical practices.
This research will address screening issues for rural patients and those residing in
communities designated as medically underserved. The interventions tested in the study will
focus on two key areas: educating the patient about the importance of screening, and
reminding the physician about the need to discuss screening during the patient's visit.

The original goal of the study was to enroll 1500 unscreened patients aged 52 to 79 years
from 16 family physician practices located in poor, rural Iowa counties. This study will
test a combination of patient and physician reminder strategies designed to ensure that the
patient is educated about CRC screening and receives a recommendation for CRC screening from
their physician. The main outcome is colorectal cancer screening by any of the accepted
methods. Rates of screening will be compared across intervention groups. We will also
determine how much the interventions cost per person screened.

Patients due for screening within each practice (based on their self-report) (never screened
or not up to date with screening) will be randomized to one of four groups that will receive
office reminder system strategies of increasing intensity: 1) Usual care, 2) Physician
chart reminder alone, 3) Physician chart reminder plus multifaceted mailed patient
education, including a postage paid fecal immunochemical test, a reminder magnet, and
returnable CRC screening test preference sheet, or 4) Physician chart reminder +
multifaceted mailed patient education/FIT/magnet/preference sheet + telephone reminder to
encourage screening and address barriers.

Our central hypothesis is that providing offices with one or more CRC screening support
systems based on the Chronic Care Model will significantly increase CRC screening rates in
comparison with usual care, and that such interventions will be cost-effective and accepted
in practice.

Inclusion Criteria:

- patients not up-to-date with CRC screening guidelines based on their responses to
baseline survey

- patients with a positive personal history of CRC

Exclusion Criteria:

- patients with personal history of CRC or inflammatory bowel disease

- patients with a family history of hereditary conditions that put them at high risk
for CRC (familial adenomatous polyposis or hereditary, nonpolyposis CRC)

- inability to read and comprehend the Informed Consent or written survey

- patients who are up-to-date with CRC screening guidelines based on their response to
the baseline survey

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Screening

Outcome Measure:

colorectal cancer screening

Outcome Description:

The main outcome measure is the percentage of subjects who complete colorectal cancer screening by any of the accepted methods

Outcome Time Frame:

15 months

Safety Issue:


Principal Investigator

Barcey T Levy, PhD, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Iowa


United States: Institutional Review Board

Study ID:




Start Date:

July 2008

Completion Date:

June 2012

Related Keywords:

  • Colorectal Cancer
  • colorectal cancer
  • screening
  • colonoscopy
  • fecal immunochemical test
  • clinical guidelines
  • Colonic Neoplasms
  • Colorectal Neoplasms



Iowa Research Network, University of Iowa Iowa City, Iowa  52242-1097