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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age55-80
SponsorM.D. Anderson Cancer Center

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Men and women 55 to 80 years of age.

Participants must speak English.

Current smoker or quit smoking within the past 15 years.

Disqualifiers

None

Trial population

Participants recruited from Houston and Galveston areas.

Trial design

Design model

Cohort

Time perspective

Cross-sectional

Treatments tested in this trial

  • 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.

Treatment groups

620 Participants
are divided into 1 treatment group
Group A: Lung Cancer Screening Decision Aids2 interventions

Trial outcomes

Primary outcomes

1

Informed Decisions About Lung Cancer Screening (Data from interviews and questionnaires reviewed to assess participant knowledge)

Data from interviews and questionnaires reviewed to assess participant knowledge regarding lung cancer screening and decision aid.

Time frame
1 Month

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

M.D. Anderson Cancer Center

Lead sponsor

Patient-Centered Outcomes Research Institute

Collaborator