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Improving Rates of Repeat Colorectal Cancer Screening

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01453894
Recruitment Status : Completed
First Posted : October 18, 2011
Results First Posted : August 15, 2014
Last Update Posted : August 15, 2014
Agency for Healthcare Research and Quality (AHRQ)
Information provided by (Responsible Party):
David Baker, Northwestern University

Brief Summary:

The United States Preventive Services Task Force (USPSTF) recommends colorectal cancer (CRC) screening using fecal occult blood testing (FOBT), sigmoidoscopy, or colonoscopy in adults, beginning at age 50 and continuing until age 75. However, rates of CRC screening remain inadequate. In 2006, only 60.8% of adults 50 or older reported recent CRC screening. Screening rates are even lower among Black and Hispanic populations and in areas with higher poverty rates. Annual or biennial FOBT testing over many years is essential for FOBT to be effective. Few studies have examined the rate of repeat FOBT testing; to the investigators knowledge, none have been conducted in populations with high prevalence of barriers to screening (e.g., low literacy, varied cultural norms, and transportation difficulties). The assumption that FOBT is an effective CRC screening strategy presumes it will be done at least biennially, and cost-effectiveness studies of CRC screening strategies have found that the results are sensitive to the rate of adherence. The investigators study will provide critical information for providers and policymakers as they consider optimal strategies to increase CRC screening among vulnerable populations.

Overall Study Goal: Improve colorectal cancer screening by increasing rates of repeat fecal occult blood testing (FOBT).

Aim 1: Test if a multifaceted intervention increases repeat FOBT testing adherence over a 30-month period

Hypothesis 1: Compared to usual care, the intervention will increase the proportion of patients who complete a repeat annual FOBT within 6 months of their due date.

Hypothesis 2: Compared to usual care, the intervention will increase the proportion of patients who complete 2 additional FOBTs over the 30-month intervention period.

Aim 2: Explore perceived barriers to screening among patients who received the intervention but did not complete repeat FOBT testing within 18 months

Aim 3: Assess the costs of the intervention and the costs per additional repeat screening compared to patients who received usual care.

Condition or disease Intervention/treatment Phase
Colorectal Neoplasms Behavioral: Reminder and Outreach Intervention Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 450 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Screening
Official Title: Center for Advancing Equity in Clinical Preventive Services Project 1: Improving Rates of Repeat Colorectal Cancer Screening
Study Start Date : March 2012
Actual Primary Completion Date : August 2013
Actual Study Completion Date : August 2013

Arm Intervention/treatment
Experimental: Reminder and Outreach Intervention
Participants randomized to this arm will receive the Reminder and Outreach intervention.
Behavioral: Reminder and Outreach Intervention
This intervention includes (1) phone calls and text messages to remind participants that they are due for colorectal cancer (CRC) screening (2) mailed fecal occult blood test (FOBT) to participants so they can perform the test conveniently at home and mail them to the clinic, avoiding the need for a visit (3) plain language information and instructions to support understanding of CRC and FOBT use (4) a CRC screening coordinator to contact those still failing to complete testing by telephone or text (5) a feedback loop to patients regarding test results.

No Intervention: Usual Care Control Group
Patients assigned to this arm will receive usual care.

Primary Outcome Measures :
  1. Completion of a Fecal Occult Blood Test (FOBT) [ Time Frame: within 6 months of randomization ]
    This outcome will be categorized as Completed FOBT if a participant's chart has documentation of a completed FOBT screening test. Outcomes will be assessed by querying the electronic health record (EHR) for all participants.

Information from the National Library of Medicine

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Ages Eligible for Study:   51 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Fecal occult blood test (FOBT) completed in the past year
  • Age 51-75
  • Preferred language English or Spanish

Exclusion Criteria:

  • Any of the following: (1) Colonoscopy within 10 years (2) Flexible sigmoidoscopy within 5 years or (3) A clinician order or referral for FOBT prior to the due date
  • Documentation of medical conditions suggesting colorectal cancer (CRC) screening through FOBT may be inappropriate including: chronic diarrhea, inflammatory bowel disease, iron deficiency, previous colonic polyp, use of medications in the previous 1 month that elevate the risk of a false-positive FOBT

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 identifier (NCT number): NCT01453894

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United States, Illinois
Northwestern University
Chicago, Illinois, United States, 60611
Sponsors and Collaborators
Northwestern University
Agency for Healthcare Research and Quality (AHRQ)
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Principal Investigator: David W Baker, MD MPH Northwestern University
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: David Baker, Chief, Division of General Internal Medicine, Northwestern University Identifier: NCT01453894    
Other Study ID Numbers: 1P01HS021141-01-Project1
1P01HS021141-01 ( U.S. NIH Grant/Contract )
First Posted: October 18, 2011    Key Record Dates
Results First Posted: August 15, 2014
Last Update Posted: August 15, 2014
Last Verified: July 2014
Keywords provided by David Baker, Northwestern University:
Colorectal Cancer Screening
Fecal Occult Blood Testing
Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases