Tailored Interactive Intervention to Increase CRCS

NCT ID: NCT01084746

Last Updated: 2018-05-11

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

1224 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-01-31

Study Completion Date

2008-06-30

Brief Summary

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The primary goal of this research project is to conduct a 5-year prospective randomized trial of a theory-based intervention to increase patient completion of colorectal cancer screening (CRCS) among patients ages 50 to 64 years old.

Detailed Description

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Specific Aim 1: Identify behavioral, social, and environmental factors associated with CRCS in male and female patients ages 50 to 64 years old in a primary care practice in Houston, Texas.

1.1. Update literature reviews of CRCS adherence. 1.2. Conduct secondary analysis of relevant data from other projects. 1.3. Conduct focus groups with primary care patients to determine their knowledge, attitudes, and beliefs about CRCS and to gather data to use for development of the educational intervention.

Specific Aim 2: Develop a personal computer (PC)-based tailored interactive intervention based on the transtheoretical (stages of change) model to increase CRCS in accordance with American Cancer Society (ACS) CRCS guidelines.

Specific Aim 3: Evaluate the effectiveness of the PC-based tailored interactive intervention for increasing CRCS through a randomized controlled trial.

Specific Aim 4: Analyze the relationship between a number of predictor variables and CRCS completion in order to develop a more complete conceptual framework for understanding screening adherence.

Specific Aim 5: Conduct a cost-effectiveness analysis of the PC-based tailored interactive intervention for increasing CRCS in a primary care setting.

Conditions

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Colorectal Cancer Screening

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Caregivers

Study Groups

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PC-based tailored intervention

Group Type ACTIVE_COMPARATOR

PC-based tailored intervention

Intervention Type BEHAVIORAL

Patients will receive a tailored interactive PC-based intervention at a freestanding kiosk.

Printed educational materials

Group Type ACTIVE_COMPARATOR

Printed educational materials

Intervention Type BEHAVIORAL

Patients will receive generic printed educational materials about CRCS in the PEC when they arrive at the Main Campus for their appointment.

No patient intervention

Patients will not receive a patient-directed intervention.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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PC-based tailored intervention

Patients will receive a tailored interactive PC-based intervention at a freestanding kiosk.

Intervention Type BEHAVIORAL

Printed educational materials

Patients will receive generic printed educational materials about CRCS in the PEC when they arrive at the Main Campus for their appointment.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Receive primary care at the KSC Main Campus in Houston, Texas.
* Must have been patients at KSC for at least one year prior to enrollment in the study
* Be 50 to 64 years of age
* Have had CRC or adenomatous polyps
* Must agree to schedule a routine physical examination with their primary care provider and to complete a baseline interview

Exclusion Criteria

-Have never been screened or be due for CRCS according to the ACS guidelines
Minimum Eligible Age

50 Years

Maximum Eligible Age

64 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

The University of Texas Health Science Center, Houston

OTHER

Sponsor Role lead

Responsible Party

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Sally Vernon

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Sally W Vernon, PhD

Role: PRINCIPAL_INVESTIGATOR

The University of Texas Health Science Center, Houston

Locations

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University of Texas Health Science Center at Houston School of Public Health

Houston, Texas, United States

Site Status

Countries

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United States

References

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McQueen A, Tiro JA, Vernon SW. Construct validity and invariance of four factors associated with colorectal cancer screening across gender, race, and prior screening. Cancer Epidemiol Biomarkers Prev. 2008 Sep;17(9):2231-7. doi: 10.1158/1055-9965.EPI-08-0176.

Reference Type RESULT
PMID: 18768488 (View on PubMed)

Greisinger A, Hawley ST, Bettencourt JL, Perz CA, Vernon SW. Primary care patients' understanding of colorectal cancer screening. Cancer Detect Prev. 2006;30(1):67-74. doi: 10.1016/j.cdp.2005.10.001. Epub 2006 Feb 2.

Reference Type RESULT
PMID: 16458449 (View on PubMed)

Lairson DR, Chang YC, Bettencourt JL, Vernon SW, Greisinger A. Estimating development cost for a tailored interactive computer program to enhance colorectal cancer screening compliance. J Am Med Inform Assoc. 2006 Sep-Oct;13(5):476-84. doi: 10.1197/jamia.M2067. Epub 2006 Jun 23.

Reference Type RESULT
PMID: 16799126 (View on PubMed)

Other Identifiers

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R01CA097263-05

Identifier Type: NIH

Identifier Source: secondary_id

View Link

HSC-SPH-01-084

Identifier Type: -

Identifier Source: org_study_id

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