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

Health Knowledge, Attitudes, Practice Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02282969
• Other study ID #: PA14-0072
• Secondary ID: CER-1306-03385
• Status: Recruiting
• Start date: July 11, 2014
• Est. completion date: August 31, 2025

Study information

• Verified date: February 2024
• Source: M.D. Anderson Cancer Center
• Contact: Robert Volk, PHD
• Phone: 713-563-2509
• Email: BVolk[@]mdanderson.org
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 620
• Est. completion date: August 31, 2025
• Est. primary completion date: August 31, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 55 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Health Knowledge, Attitudes, Practice
• Lung Neoplasms

Intervention

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

Locations

Country	Name	City	State
United States	The University of Texas Medical Branch at Galveston	Galveston	Texas
United States	University of Texas MD Anderson Cancer Center	Houston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
M.D. Anderson Cancer Center	Patient-Centered Outcomes Research Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	1 Month

External Links

•   University of Texas MD Anderson Cancer Center Website