Clinical trial NCT02282969: PCORI-CER-1306-03385 Lung Cancer Screening Decision Aid Development and Testing
Official title: Promoting Informed Decisions About Lung Cancer Screening: Decision Aid Update and Measures Development
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Health Knowledge, Attitudes, Practice
Keywords: Cancer Prevention
Smokers
Quit smoking
Interviews
Questionnaires
Surveys
Lung cancer screening
Patient decision aid
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
Collaborators: name: Patient-Centered Outcomes Research Institute
First posted: 2014-11-05
Enrollment: 620
Sex: ALL
Minimum age (years): 55
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants recruited from Houston and Galveston areas.

Brief 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Informed Decisions About Lung Cancer Screening (Data from interviews and questionnaires reviewed to assess participant knowledge)
timeFrame: 1 Month
Secondary outcomes:
Other outcomes:
Locations:
city: Galveston
country: United States
facility: The University of Texas Medical Branch at Galveston
state: Texas
city: Houston
country: United States
facility: University of Texas MD Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Robert Volk, PHD
role: STUDY_CHAIR
affiliation: The University of Texas Medical Branch at Galveston
name: Suzanne Linder, PHD
role: PRINCIPAL_INVESTIGATOR
affiliation: M.D. Anderson Cancer Center
name: Paul Cinciripini, PHD, MS, BS
role: PRINCIPAL_INVESTIGATOR
References: