Tailored Interactive Intervention to Increase CRCS

Colorectal Cancer Screening Clinical Trial

— PCCaSO  

Official title:

Tailored Interactive Intervention to Increase CRCS

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01084746
• Other study ID #: HSC-SPH-01-084
• Secondary ID: R01CA097263-05
• Status: Completed
• Phase: N/A
• Start date: January 2005
• Est. completion date: June 2008

Study information

• Verified date: May 2018
• Source: The University of Texas Health Science Center, Houston
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1224
• Est. completion date: June 2008
• Est. primary completion date: June 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years to 64 Years

Eligibility

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

Related Conditions & MeSH terms

• Colorectal Cancer Screening
• Colorectal Neoplasms

Intervention

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

Locations

Country	Name	City	State
United States	University of Texas Health Science Center at Houston School of Public Health	Houston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
The University of Texas Health Science Center, Houston	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

References & Publications (3)

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. Epub 2006 Feb 2. — View Citation

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. Epub 2006 Jun 23. — View Citation

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-08-0 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Increase patient completion of colorectal cancer screening (CRCS) among patients ages 50 to 64 years old.	6, 12, and 24 months post intervention, medical charts were reviewed to validate self-reported CRCS behavior.	6months, 12months, 24 months
Secondary	Secondary goals are to increase understanding of factors that predict completion of CRCS and to assess the cost-effectiveness of the intervention.	Survey data were collected at 6,12,and 24 months.	6 months, 12 months, 24 months