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PCORI-CER-1306-03385 Lung Cancer Screening Decision Aid Development and Testing

NCT02282969 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 620

Last updated 2026-01-20

No results posted yet for this study

Summary

Objectives:

This protocol addresses the first phase of a larger project funded by the Patient-Centered Outcomes Research Institute to help heavy smokers make informed decisions about lung cancer screening with low-dose computed tomography (CT). A separate IRB protocol will be submitted for the larger, comparative study. In this initial development phase, our prototype patient decision aid will be updated to reflect current guidelines about lung cancer screening. The updated aid will then be pilot-tested in a new sample of patients. In addition, several of the study measures will be refined and further developed in preparation for the larger study.

The specific aims of the measures and decision aid development phase of this project are as follows:

Update the aid to reflect current screening guidelines and refine the aid via cognitive testing with patients/smokers; and pilot test the updated aid for acceptability with patients/smokers.

Modify our current measure of lung cancer knowledge, conduct cognitive testing of the new measure with patients/smokers, and evaluate the reliability of the new measure in a sample patients/smokers.

Conditions

  • Health Knowledge, Attitudes, Practice

Interventions

BEHAVIORAL

Interviews

Interviews performed by study staff encompassing lung cancer screening and patient decision aids.

BEHAVIORAL

Questionnaires

Questionnaires completed after viewing patient decision aid video. Questionnaires also completed regarding lung cancer screening knowledge at first visit, then again in one month.

Sponsors & Collaborators

  • Patient-Centered Outcomes Research Institute

    collaborator OTHER

  • M.D. Anderson Cancer Center

    lead OTHER

Principal Investigators

  • Robert Volk, PHD · M.D. Anderson Cancer Center

  • Suzanne Linder, PHD · The University of Texas Medical Branch at Galveston

  • Paul Cinciripini, PHD, MS, BS · M.D. Anderson Cancer Center

Eligibility

Min Age
55 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-07-11
Primary Completion
2028-08-31
Completion
2028-08-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02282969 on ClinicalTrials.gov