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Tailored Interactive Intervention to Increase CRCS (PCCaSO)

This study has been completed.
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by:
The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier:
NCT01084746
First received: March 9, 2010
Last updated: NA
Last verified: March 2010
History: No changes posted
  Purpose

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.


Condition Intervention
Colorectal Cancer Screening
 Behavioral: Tailored interactive intervention to increasing CRCS

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Caregiver)
Primary Purpose: Prevention
Official Title: Tailored Interactive Intervention to Increase CRCS

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by The University of Texas Health Science Center, Houston:

Primary Outcome Measures:
  • Increase patient completion of colorectal cancer screening (CRCS) among patients ages 50 to 64 years old. [ Time Frame: 6months, 12months, 24 months ] [ Designated as safety issue: No ]
    6, 12, and 24 months post intervention, medical charts were reviewd 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. [ Time Frame: 6 months, 12 months, 24 months ] [ Designated as safety issue: No ]
    Survey data were collected at 6,12,and 24 months.


Enrollment: 1224
Study Start Date: January 2005
Study Completion Date: June 2008
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: PC-based tailored intervention Behavioral: Tailored interactive intervention to increasing CRCS
The three arms of the intervention consist of no patient intervention, printed educational materials, or PC-based tailored interactive intervention.Patients in Group 1 will not receive a patient-directed intervention. Patients in Group 2 will receive generic printed educational materials about CRCS in the PEC when they arrive at the KSC Main Campus for their appointment. Patients in Group 3 will receive a tailored interactive PC-based intervention at a freestanding kiosk in the PEC.
Other Name: PCCaSO
Active Comparator: printed educational materials Behavioral: Tailored interactive intervention to increasing CRCS
The three arms of the intervention consist of no patient intervention, printed educational materials, or PC-based tailored interactive intervention.Patients in Group 1 will not receive a patient-directed intervention. Patients in Group 2 will receive generic printed educational materials about CRCS in the PEC when they arrive at the KSC Main Campus for their appointment. Patients in Group 3 will receive a tailored interactive PC-based intervention at a freestanding kiosk in the PEC.
Other Name: PCCaSO
No Intervention: no patient intervention Behavioral: Tailored interactive intervention to increasing CRCS
The three arms of the intervention consist of no patient intervention, printed educational materials, or PC-based tailored interactive intervention.Patients in Group 1 will not receive a patient-directed intervention. Patients in Group 2 will receive generic printed educational materials about CRCS in the PEC when they arrive at the KSC Main Campus for their appointment. Patients in Group 3 will receive a tailored interactive PC-based intervention at a freestanding kiosk in the PEC.
Other Name: PCCaSO

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

Ages Eligible for Study:   50 Years to 64 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01084746

Locations
United States, Texas
University of Texas Health Science Center at Houston School of Public Health
Houston, Texas, United States, 77030
Sponsors and Collaborators
The University of Texas Health Science Center, Houston
National Cancer Institute (NCI)
Investigators
Principal Investigator: Sally W Vernon, PhD The University of Texas Health Science Center, Houston
  More Information

Publications:

Responsible Party: Sally W. Vernon, University of Texas Health Science Center at Houston Center for Health Promotion and Prevention Research, School of Public Health
ClinicalTrials.gov Identifier: NCT01084746     History of Changes
Other Study ID Numbers: HSC-SPH-01-084, R01CA097263-05
Study First Received: March 9, 2010
Last Updated: March 9, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by The University of Texas Health Science Center, Houston:
Colorectal Cancer Screening
Computer Interactive Intervention
Predictors
Cost Effective Analysis
Transtheoretical Model

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
 Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases

ClinicalTrials.gov processed this record on May 21, 2013