Tailored Interactive Intervention to Increase CRCS

Study Overview
=================
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.

Official Title
-----------------
Tailored Interactive Intervention to Increase CRCS

Conditions
-----------------
Colorectal Cancer Screening

Intervention / Treatment
-----------------
* Behavioral: PC-based tailored intervention
* Behavioral: Printed educational materials


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 50 Years
Maximum Age: 64 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: PC-based tailored intervention<br> | Behavioral: PC-based tailored intervention<br>* Patients will receive a tailored interactive PC-based intervention at a freestanding kiosk.<br>|
| Active Comparator: Printed educational materials<br> | Behavioral: Printed educational materials<br>* Patients will receive generic printed educational materials about CRCS in the PEC when they arrive at the Main Campus for their appointment.<br>|
| No Intervention: No patient intervention<br>Patients will not receive a patient-directed intervention. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Colorectal Cancer Screening, Computer Interactive Intervention, Predictors, Cost Effective Analysis, Transtheoretical Model