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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
  Purpose

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 Intervention Phase
Colorectal Cancer Screening
Behavioral: Tailored counseling
Behavioral: Motivational Interview
Behavioral: control
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Screening
Official Title: Increasing CRC Screening in Primary Care Settings

Resource links provided by NLM:


Further study details as provided by Arizona State University:

Primary Outcome Measures:
  • completing CRC screening test [ Time Frame: 1 and 6 months post education ] [ Designated as safety issue: No ]

Enrollment: 511
Study Start Date: October 2004
Study Completion Date: January 2010
Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Behavioral: control
Usual care

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.

  Eligibility

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

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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
Investigators
Principal Investigator: Usha Menon, PhD Arizona State University
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Usha Menon, Arizona State University
ClinicalTrials.gov Identifier: NCT01099826     History of Changes
Other Study ID Numbers: R01NR8425
Study First Received: April 6, 2010
Last Updated: April 7, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by Arizona State University:
colorectal cancer screening
tailored education
motivational interview
patient education

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

ClinicalTrials.gov processed this record on November 20, 2014