ClinicalTrials.gg
RecruitingNCT02282969Updated Jul 16, 2026

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

An observational study in Health Knowledge, Attitudes, Practice, sponsored by M.D. Anderson Cancer Center. Recruiting at 2 sites in United States. Open to participants aged 55 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-07-16.

Sponsored by M.D. Anderson Cancer Center · Observational

From the registry’s dates

  • Started Jul 2014; still recruiting 12 years 4 months later.
Study type
Observational
Model
Cohort
Time perspective
Cross-sectional
Enrollment
620
Ages
55 Years to 80 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Health Knowledge, Attitudes, Practice

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Keywords

  • Cancer Prevention
  • Smokers
  • Quit smoking
  • Interviews
  • Questionnaires
  • Surveys
  • Lung cancer screening
  • Patient decision aid
03

In context

Behavior

1,573 studies on the registry are indexed under Behavior; 313 are open to participants now.

This study's planned enrollment of 620 is above the median of 235 across 341 observational studies indexed under Behavior.

Browse Behavior studies →

Lead sponsor

M.D. Anderson Cancer Center is the lead sponsor of 3,047 studies on the registry; 578 are open to participants now.

Of its 612 completed or terminated interventional studies of FDA-regulated products, 409 (67%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
55 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Participants recruited from Houston and Galveston areas.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

1. History of lung cancer.

05

Study design

Observational model
Cohort
Time perspective
Cross-sectional
Enrollment
620 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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.

    Behavioral: Interviews · Behavioral: Questionnaires

Interventions

  • BehavioralInterviews

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

  • BehavioralQuestionnaires

    Questionnaires completed after viewing patient decision aid video. Questionnaires also completed regarding lung cancer screening knowledge at first visit, then again in one month.

    Also known as: Surveys

06

What researchers measure

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

07

Study locations

2 of 2 sites recruiting
08

References and documents

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Jul 2014 (actual). Primary completion is estimated for Aug 2028, 169 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 31, 2014
First posted
Nov 5, 2014
StartActual
Jul 11, 2014
Primary completionEst.
Aug 31, 2028
CompletionEst.
Aug 31, 2028
Last update
Jul 16, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 16, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02282969
Collaborators
Patient-Centered Outcomes Research Institute
Responsible party
Sponsor
First posted
Nov 5, 2014
Start date
Jul 11, 2014
Primary completion
Aug 31, 2028 (estimated)
Completion
Aug 31, 2028 (estimated)
Last update
Jul 16, 2026

Study contacts

Robert Volk, PHD
Contact
BVolk@mdanderson.org
713-563-2509
Robert Volk, PHD
study chair · M.D. Anderson Cancer Center
Suzanne Linder, PHD
principal investigator · The University of Texas Medical Branch at Galveston
Paul Cinciripini, PHD, MS, BS
principal investigator · M.D. Anderson Cancer Center

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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