NCT01084746

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,224

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2005

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2005

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2008

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

March 9, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 10, 2010

Completed
Last Updated

May 11, 2018

Status Verified

May 1, 2018

Enrollment Period

3.4 years

First QC Date

March 9, 2010

Last Update Submit

May 3, 2018

Conditions

Colorectal Cancer Screening

Keywords

Colorectal Cancer ScreeningComputer Interactive InterventionPredictorsCost Effective AnalysisTranstheoretical Model

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Secondary goals are to increase understanding of factors that predict completion of CRCS and to assess the cost-effectiveness of the intervention.

    6 months, 12 months, 24 months

Study Arms (3)

PC-based tailored intervention

ACTIVE COMPARATOR
Behavioral: PC-based tailored intervention

Printed educational materials

ACTIVE COMPARATOR
Behavioral: Printed educational materials

No patient intervention

NO INTERVENTION

Patients will not receive a patient-directed intervention.

Interventions

PC-based tailored interventionBEHAVIORAL

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

PC-based tailored intervention
Printed educational materialsBEHAVIORAL

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

Printed educational materials

Eligibility Criteria

Age50 Years - 64 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • Have never been screened or be due for CRCS according to the ACS guidelines

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Houston, Texas, 77030, United States

Location

Related Publications (3)

  • 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.

    PMID: 18768488RESULT

  • 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.

    PMID: 16458449RESULT

  • 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.

    PMID: 16799126RESULT

Study Officials

  • Sally W Vernon, PhD

    The University of Texas Health Science Center, Houston

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
CARE PROVIDER
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

March 9, 2010

First Posted

March 10, 2010

Study Start

January 1, 2005

Primary Completion

June 1, 2008

Study Completion

June 1, 2008

Last Updated

May 11, 2018

Record last verified: 2018-05

Locations

US(1)