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
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
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
NCT ID
NCT01099826
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
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
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Increasing Colorectal Cancer (CRC) Screening In Primary Care
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