Increasing Colorectal Cancer (CRC) Screening In Primary Care

Colorectal Cancer Screening Clinical Trial

Official title:

Increasing CRC Screening in Primary Care Settings

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01099826
• Other study ID #: R01NR008425
• Status: Completed
• Phase: N/A
• Start date: October 2004
• Est. completion date: January 2010

Study information

• Verified date: February 2020
• Source: Arizona State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 511
• Est. completion date: January 2010
• Est. primary completion date: November 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Colorectal Cancer Screening
• Colorectal Neoplasms

Intervention

Behavioral:
• Tailored counseling
education tailored to baseline beliefs by trained counselor over phone
• Motivational Interview
motivational interview by trained MI counselors by phone

Locations

Country	Name	City	State
n/a

Sponsors (7)

Lead Sponsor	Collaborator
Arizona State University	Jesse Brown VA Medical Center, Penn State University, Portland State University, University of Illinois at Chicago, University of Utah, Vanderbilt University

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	completing CRC screening test		1 and 6 months post education