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

Part of paid clinical trials in Galveston, Texas.

Sponsor
M.D. Anderson Cancer Center
Study ID
NCT02282969
Status
Recruiting

Conditions

  • Health Knowledge, Attitudes, Practice

Eligibility Criteria

Sex
ALL
Age
55 Years - 80 Years
Healthy Volunteers
Accepted

Interventions

  • Interviews — BEHAVIORAL
    Interviews performed by study staff encompassing lung cancer screening and patient decision aids.
  • Questionnaires — BEHAVIORAL
    Questionnaires completed after viewing patient decision aid video. Questionnaires also completed regarding lung cancer screening knowledge at first visit, then again in one month.

Study Details

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.

Key Dates

Start date
Jul 11, 2014
Status verified
Jan 2026
Primary completion
Aug 31, 2028
Completion
Aug 31, 2028

Study Design

Enrollment
620 participants (estimated)

Arms

  • Arm: Lung Cancer Screening Decision Aids
    Participants are asked to look over education materials about lung cancer screening, and interviewed. Some participants will look at a video patient decision aid, with an interview and questionnaire completion. Some participants complete lung cancer screening knowledge questionnaire at first visit, and then again in one month.

Primary Outcome Measure

Informed Decisions About Lung Cancer Screening (Data from interviews and questionnaires reviewed to assess participant knowledge) [ Time Frame: 1 Month ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
The University of Texas Medical Branch at GalvestonGalvestonTexas77555-
University of Texas MD Anderson Cancer CenterHoustonTexas77030-

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