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Increasing Colorectal Cancer (CRC) Screening In Primary Care

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: NCT01099826
Recruitment Status : Completed
First Posted : April 8, 2010
Last Update Posted : February 5, 2020
University of Illinois at Chicago
Jesse Brown VA Medical Center
University of Utah
Vanderbilt University
Penn State University
Portland State University
Information provided by (Responsible Party):
Usha Menon, Arizona State University

Brief Summary:
Colorectal cancer screening remains lower than optimal. The purpose of this study was to test the efficacy of phone-based motivational interviewing versus tailored communication versus usual care in increasing CRC screening in primary care clinics.

Condition or disease Intervention/treatment Phase
Colorectal Cancer Screening Behavioral: Tailored counseling Behavioral: Motivational Interview Not Applicable

Detailed Description:

Regular screening reduces both morbidity and mortality from colorectal cancer (CRC). Screening rates, however, remain low suggesting the need for innovative research designed to increase screening behavior. The purpose of this study is to compare the effectiveness of two interventions (Tailored Health Communication [THC] and Motivational Interviewing [MI]) in increasing CRC screening behavior. Both interventions are based on a strong conceptual framework derived from the Health Belief Model (HBM) and Transtheoretical Model (TTM), allowing us to explore the underlying mechanisms through which these interventions impact behavior change.

The primary aim of this study is to compare CRC screening test use among 804 participants randomly allocated to control or intervention conditions; participants will be recruited from the two sites (Chicago, IL, and Nashville, TN). The 3 study groups will receive (1) standard care, (2) tailored health communication, and (3) motivational interviewing. Eligibility criteria for study participants includes being 50 years or older, not having CRC, and being of average or moderate risk for CRC. Study participants will be surveyed by telephone about CRC-related beliefs pre-intervention (Time 1), 1 month postintervention (Time 2), and at 6 months postintervention (Times 3 and 4, respectively). Dichotomous behavioral outcomes (had screening test or not) and stages of CRC screening test adoption (based on the TTM) will be assessed, as well as sociodemographic and belief predictors of screening behavior. Binomial and multinomial logistic regression models will be used to evaluate screening test use and stage of test adoption. Sociodemographic and belief variables will be used as covariates, with intervention group as the primary independent predictor. Descriptive statistics and ANOVA will be employed to assess between intervention differences in amenable beliefs. Path (mediation) analysis will be performed to further explore the underlying mechanisms through which THC and MI may differentially affect CRC screening behavior.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 511 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: Increasing CRC Screening in Primary Care Settings
Study Start Date : October 2004
Actual Primary Completion Date : November 2009
Actual Study Completion Date : January 2010

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: lifestyle counseling tailored Behavioral: Tailored counseling
education tailored to baseline beliefs by trained counselor over phone

Experimental: lifestyle counseling motivational Behavioral: Motivational Interview
motivational interview by trained MI counselors by phone

No Intervention: control

Primary Outcome Measures :
  1. completing CRC screening test [ Time Frame: 1 and 6 months post education ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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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

Inclusion Criteria:

  • all genders
  • can speak, read, write English
  • no diagnosis of colorectal cancer
  • non-adherent with screening
  • age 50 or older

Exclusion Criteria:

  • had colorectal cancer
  • adherent with screening

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): NCT01099826

Sponsors and Collaborators
Arizona State University
University of Illinois at Chicago
Jesse Brown VA Medical Center
University of Utah
Vanderbilt University
Penn State University
Portland State University
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Principal Investigator: Usha Menon, PhD Arizona State University
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Usha Menon, Faculty, Arizona State University Identifier: NCT01099826    
Other Study ID Numbers: R01NR008425 ( U.S. NIH Grant/Contract )
First Posted: April 8, 2010    Key Record Dates
Last Update Posted: February 5, 2020
Last Verified: February 2020
Keywords provided by Usha Menon, Arizona State University:
colorectal cancer screening
tailored education
motivational interview
patient education
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