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Completed

NCT Number: NCT01084746

Tailored Interactive Intervention to Increase CRCS

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.

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Key information

Age range

50 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Texas Health Science Center at Houston School of Public Health

Houston, Texas, 77030, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PC-based tailored intervention

Behavioral

Patients will receive a tailored interactive PC-based intervention at a freestanding kiosk.

Printed Educational Materials

Behavioral

Patients will receive generic printed educational materials about CRCS in the PEC when they arrive at the Main Campus for their appointment.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

The University of Texas Health Science Center, Houston

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Acronym: PCCaSO

Important dates

Study start
2005
Primary completion
2008
Study completion
2008
First posted
Mar 10, 2010
Registry last updated
May 11, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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