Tailored Interactive Intervention to Increase CRCS (PCCaSO)

May 3, 2018 updated by: Sally Vernon, The University of Texas Health Science Center, Houston
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

1224

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77030
        • University of Texas Health Science Center at Houston School of Public Health

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 64 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: PC-based tailored intervention
Behavioral: PC-based tailored intervention
Patients will receive a tailored interactive PC-based intervention at a freestanding kiosk.
Active Comparator: Printed educational materials
Behavioral: 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.
No Intervention: No patient intervention
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.
Time Frame: 6months, 12months, 24 months
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.
Time Frame: 6 months, 12 months, 24 months
Survey data were collected at 6,12,and 24 months.
6 months, 12 months, 24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The University of Texas Health Science Center, Houston

Collaborators

National Cancer Institute (NCI)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2005

Primary Completion (Actual)

June 1, 2008

Study Completion (Actual)

June 1, 2008

Study Registration Dates

First Submitted

March 9, 2010

First Submitted That Met QC Criteria

March 9, 2010

First Posted (Estimate)

March 10, 2010

Study Record Updates

Last Update Posted (Actual)

May 11, 2018

Last Update Submitted That Met QC Criteria

May 3, 2018

Last Verified

May 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HSC-SPH-01-084
  • R01CA097263-05 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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