Clinical trial NCT01084746: Tailored Interactive Intervention to Increase CRCS
Official title: Tailored Interactive Intervention to Increase CRCS
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colorectal Cancer Screening
Keywords: Colorectal Cancer Screening
Computer Interactive Intervention
Predictors
Cost Effective Analysis
Transtheoretical Model
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2010-03-10
Enrollment: 1224
Sex: ALL
Minimum age (years): 50
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Increase patient completion of colorectal cancer screening (CRCS) among patients ages 50 to 64 years old.
timeFrame: 6months, 12months, 24 months
Secondary outcomes:
measure: Secondary goals are to increase understanding of factors that predict completion of CRCS and to assess the cost-effectiveness of the intervention.
timeFrame: 6 months, 12 months, 24 months
Other outcomes:
Locations:
city: Houston
country: United States
facility: University of Texas Health Science Center at Houston School of Public Health
state: Texas
Study officials:
affiliation: The University of Texas Health Science Center, Houston
name: Sally W Vernon, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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-08-0176.
citation: 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.
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. doi: 10.1197/jamia.M2067. Epub 2006 Jun 23.