Increasing Colorectal Cancer (CRC) Screening In Primary Care
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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 |
- 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 |
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| 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 Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms |
Digestive System Diseases Gastrointestinal Diseases Colonic Diseases Intestinal Diseases Rectal Diseases |
ClinicalTrials.gov processed this record on June 18, 2013