Increasing Colorectal Cancer (CRC) Screening In Primary Care

This study has been completed.
Sponsor:
Collaborators:
University of Illinois at Chicago
Jesse Brown VA Medical Center
University of Utah
Vanderbilt University
Penn State University
Portland State University
Information provided by:
Arizona State University
ClinicalTrials.gov Identifier:
NCT01099826
First received: April 6, 2010
Last updated: April 7, 2010
Last verified: April 2010

April 6, 2010
April 7, 2010
October 2004
November 2009   (final data collection date for primary outcome measure)
completing CRC screening test [ Time Frame: 1 and 6 months post education ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01099826 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Increasing Colorectal Cancer (CRC) Screening In Primary Care
Increasing CRC Screening in Primary Care Settings

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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Screening
Colorectal Cancer Screening
  • Behavioral: Tailored counseling
    education tailored to baseline beliefs by trained counselor over phone
  • Behavioral: Motivational Interview
    motivational interview by trained MI counselors by phone
  • Behavioral: control
    Usual care
  • Experimental: lifestyle counseling tailored
    Intervention: Behavioral: Tailored counseling
  • Experimental: lifestyle counseling motivational
    Intervention: Behavioral: Motivational Interview
  • No Intervention: control
    Intervention: Behavioral: control

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
511
January 2010
November 2009   (final data collection date for primary outcome measure)

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
Both
50 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01099826
R01NR8425
Yes
Usha Menon, Arizona State University
Arizona State University
  • University of Illinois at Chicago
  • Jesse Brown VA Medical Center
  • University of Utah
  • Vanderbilt University
  • Penn State University
  • Portland State University
Principal Investigator: Usha Menon, PhD Arizona State University
Arizona State University
April 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP