Increasing Colorectal Cancer (CRC) Screening In Primary Care

NCT ID: NCT01099826

Last Updated: 2020-02-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

511 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-10-31

Study Completion Date

2010-01-31

Brief Summary

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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

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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.

Conditions

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Colorectal Cancer Screening

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

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lifestyle counseling tailored

Group Type EXPERIMENTAL

Tailored counseling

Intervention Type BEHAVIORAL

education tailored to baseline beliefs by trained counselor over phone

lifestyle counseling motivational

Group Type EXPERIMENTAL

Motivational Interview

Intervention Type BEHAVIORAL

motivational interview by trained MI counselors by phone

control

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Tailored counseling

education tailored to baseline beliefs by trained counselor over phone

Intervention Type BEHAVIORAL

Motivational Interview

motivational interview by trained MI counselors by phone

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

50 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Illinois at Chicago

OTHER

Sponsor Role collaborator

Jesse Brown VA Medical Center

FED

Sponsor Role collaborator

University of Utah

OTHER

Sponsor Role collaborator

Vanderbilt University

OTHER

Sponsor Role collaborator

Penn State University

OTHER

Sponsor Role collaborator

Portland State University

OTHER

Sponsor Role collaborator

Arizona State University

OTHER

Sponsor Role lead

Responsible Party

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Usha Menon

Faculty

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Usha Menon, PhD

Role: PRINCIPAL_INVESTIGATOR

Arizona State University

References

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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.

Reference Type BACKGROUND
PMID: 18467066 (View on PubMed)

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.

Reference Type DERIVED
PMID: 21826576 (View on PubMed)

Other Identifiers

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R01NR008425

Identifier Type: NIH

Identifier Source: org_study_id

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