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

February 8, 2024 updated by: M.D. Anderson Cancer Center

Promoting Informed Decisions About Lung Cancer Screening: Decision Aid Update and Measures Development

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.

Study Overview

Detailed Description

Cognitive and Pilot Testing:

If you agree to take part in this study, you will take part in an interview with a member of the research staff. The interviewer will take notes of your responses. First, you will be asked some questions about you, like your age, sex, race, and education level. Then you will be asked to look at some educational materials about lung cancer screening. These could be written information, animations, graphics, videos, or questionnaires. You may be asked questions about:

  • Lung cancer and lung cancer screening
  • The length of the materials
  • The balance of the information found in the materials

The study interview will take place in person at MD Anderson and will take between 1 and 1 ½ hours.

Your participation on this study will be over once the interview is complete.

This is an investigational study.

Up to 50 participants will be enrolled in this part of the study. All will take part at MD Anderson, UTMB, the Galveston community, or tobacco-related community events.

Measures Reliability Study:

If you agree to take part in this study, you will complete a questionnaire 2 times. The questionnaire will ask about:

  • Lung cancer
  • Lung cancer screening
  • Making decisions about screening
  • Your age, race, gender, and level of education

You will complete the first questionnaire in person. It will take about 20 minutes to fill out. Then, about 1 month later, you will be asked to fill out the questionnaire again.

The second time you can come in person, or fill out the questionnaire by mail or telephone. Your participation will be over when the second questionnaire is complete.

This is an investigational study.

Up to 150 participants will be enrolled in this part of the study. All will take part at MD Anderson, UTMB, the Galveston community, or tobacco-related community events.

Study Type

Observational

Enrollment (Estimated)

620

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

    • Texas
      • Galveston, Texas, United States, 77555
        • Recruiting
        • The University of Texas Medical Branch at Galveston
      • Houston, Texas, United States, 77030
        • Recruiting
        • University of Texas MD Anderson Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

55 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Participants recruited from Houston and Galveston areas.

Description

Inclusion Criteria:

  1. Men and women 55 to 80 years of age.
  2. Participants must speak English.
  3. Current smoker or quit smoking within the past 15 years.

Exclusion Criteria:

1. History of lung cancer.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
Interviews performed by study staff encompassing lung cancer screening and patient decision aids.
Questionnaires completed after viewing patient decision aid video. Questionnaires also completed regarding lung cancer screening knowledge at first visit, then again in one month.
Other Names:
  • Surveys

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Informed Decisions About Lung Cancer Screening (Data from interviews and questionnaires reviewed to assess participant knowledge)
Time Frame: 1 Month
Data from interviews and questionnaires reviewed to assess participant knowledge regarding lung cancer screening and decision aid.
1 Month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Paul Cinciripini, PHD, MS, BS, M.D. Anderson Cancer Center
  • Study Chair: Robert Volk, PHD, M.D. Anderson Cancer Center
  • Principal Investigator: Suzanne Linder, PHD, The University of Texas Medical Branch at Galveston

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 11, 2014

Primary Completion (Estimated)

August 31, 2025

Study Completion (Estimated)

August 31, 2025

Study Registration Dates

First Submitted

October 31, 2014

First Submitted That Met QC Criteria

November 4, 2014

First Posted (Estimated)

November 5, 2014

Study Record Updates

Last Update Posted (Actual)

February 9, 2024

Last Update Submitted That Met QC Criteria

February 8, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • PA14-0072
  • CER-1306-03385 (Other Grant/Funding Number: Patient Centered Outcomes Research Institute)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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