Tailored Interactive Intervention to Increase CRCS (PCCaSO)
Primary Purpose
Colorectal Cancer Screening
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
PC-based tailored intervention
Printed educational materials
Sponsored by
About this trial
This is an interventional prevention trial for Colorectal Cancer Screening focused on measuring Colorectal Cancer Screening, Computer Interactive Intervention, Predictors, Cost Effective Analysis, Transtheoretical Model
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
Sites / Locations
- University of Texas Health Science Center at Houston School of Public Health
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
No Intervention
Arm Label
PC-based tailored intervention
Printed educational materials
No patient intervention
Arm Description
Patients will not receive a patient-directed intervention.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT01084746
First Posted
March 9, 2010
Last Updated
May 3, 2018
Sponsor
The University of Texas Health Science Center, Houston
Collaborators
National Cancer Institute (NCI)
1. Study Identification
Unique Protocol Identification Number
NCT01084746
Brief Title
Tailored Interactive Intervention to Increase CRCS
Acronym
PCCaSO
Official Title
Tailored Interactive Intervention to Increase CRCS
Study Type
Interventional
2. Study Status
Record Verification Date
May 2018
Overall Recruitment Status
Completed
Study Start Date
January 2005 (undefined)
Primary Completion Date
June 2008 (Actual)
Study Completion Date
June 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The University of Texas Health Science Center, Houston
Collaborators
National Cancer Institute (NCI)
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer Screening
Keywords
Colorectal Cancer Screening, Computer Interactive Intervention, Predictors, Cost Effective Analysis, Transtheoretical Model
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care Provider
Allocation
Randomized
Enrollment
1224 (Actual)
8. Arms, Groups, and Interventions
Arm Title
PC-based tailored intervention
Arm Type
Active Comparator
Arm Title
Printed educational materials
Arm Type
Active Comparator
Arm Title
No patient intervention
Arm Type
No Intervention
Arm Description
Patients will not receive a patient-directed intervention.
Intervention Type
Behavioral
Intervention Name(s)
PC-based tailored intervention
Intervention Description
Patients will receive a tailored interactive PC-based intervention at a freestanding kiosk.
Intervention Type
Behavioral
Intervention Name(s)
Printed educational materials
Intervention Description
Patients will receive generic printed educational materials about CRCS in the PEC when they arrive at the Main Campus for their appointment.
Primary Outcome Measure Information:
Title
Increase patient completion of colorectal cancer screening (CRCS) among patients ages 50 to 64 years old.
Description
6, 12, and 24 months post intervention, medical charts were reviewed to validate self-reported CRCS behavior.
Time Frame
6months, 12months, 24 months
Secondary Outcome Measure Information:
Title
Secondary goals are to increase understanding of factors that predict completion of CRCS and to assess the cost-effectiveness of the intervention.
Description
Survey data were collected at 6,12,and 24 months.
Time Frame
6 months, 12 months, 24 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sally W Vernon, PhD
Organizational Affiliation
The University of Texas Health Science Center, Houston
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Texas Health Science Center at Houston School of Public Health
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
18768488
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.
Results Reference
result
PubMed Identifier
16458449
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.
Results Reference
result
PubMed Identifier
16799126
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.
Results Reference
result
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Tailored Interactive Intervention to Increase CRCS
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