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Increasing Colorectal Cancer (CRC) Screening In Primary Care

Primary Purpose

Colorectal Cancer Screening

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Tailored counseling
Motivational Interview
Sponsored by
Arizona State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Colorectal Cancer Screening focused on measuring colorectal cancer screening, tailored education, motivational interview, patient education

Eligibility Criteria

50 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Experimental

    No Intervention

    Arm Label

    lifestyle counseling tailored

    lifestyle counseling motivational

    control

    Arm Description

    Outcomes

    Primary Outcome Measures

    completing CRC screening test

    Secondary Outcome Measures

    Full Information

    First Posted
    April 6, 2010
    Last Updated
    February 2, 2020
    Sponsor
    Arizona State University
    Collaborators
    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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    1. Study Identification

    Unique Protocol Identification Number
    NCT01099826
    Brief Title
    Increasing Colorectal Cancer (CRC) Screening In Primary Care
    Official Title
    Increasing CRC Screening in Primary Care Settings
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2020
    Overall Recruitment Status
    Completed
    Study Start Date
    October 2004 (undefined)
    Primary Completion Date
    November 2009 (Actual)
    Study Completion Date
    January 2010 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Arizona State University
    Collaborators
    University of Illinois at Chicago, Jesse Brown VA Medical Center, University of Utah, Vanderbilt University, Penn State University, Portland State University

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Colorectal Cancer Screening
    Keywords
    colorectal cancer screening, tailored education, motivational interview, patient education

    7. Study Design

    Primary Purpose
    Screening
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    511 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    lifestyle counseling tailored
    Arm Type
    Experimental
    Arm Title
    lifestyle counseling motivational
    Arm Type
    Experimental
    Arm Title
    control
    Arm Type
    No Intervention
    Intervention Type
    Behavioral
    Intervention Name(s)
    Tailored counseling
    Intervention Description
    education tailored to baseline beliefs by trained counselor over phone
    Intervention Type
    Behavioral
    Intervention Name(s)
    Motivational Interview
    Intervention Description
    motivational interview by trained MI counselors by phone
    Primary Outcome Measure Information:
    Title
    completing CRC screening test
    Time Frame
    1 and 6 months post education

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    50 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility 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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Usha Menon, PhD
    Organizational Affiliation
    Arizona State University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    18467066
    Citation
    Wahab S, Menon U, Szalacha L. Motivational interviewing and colorectal cancer screening: a peek from the inside out. Patient Educ Couns. 2008 Aug;72(2):210-7. doi: 10.1016/j.pec.2008.03.023. Epub 2008 May 8.
    Results Reference
    background
    PubMed Identifier
    21826576
    Citation
    Menon U, Belue R, Wahab S, Rugen K, Kinney AY, Maramaldi P, Wujcik D, Szalacha LA. A randomized trial comparing the effect of two phone-based interventions on colorectal cancer screening adherence. Ann Behav Med. 2011 Dec;42(3):294-303. doi: 10.1007/s12160-011-9291-z.
    Results Reference
    derived

    Learn more about this trial

    Increasing Colorectal Cancer (CRC) Screening In Primary Care

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