Health Knowledge, Attitudes, PracticeNCT02282969
PCORI-CER-1306-03385 Lung Cancer Screening Decision Aid Development and Testing
An observational study of Health Knowledge, Attitudes, Practice, run by M.D. Anderson Cancer Center at 2 sites in United States.
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). Read more about this study
- Who is it for?
- Ages 55 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Health Knowledge, Attitudes, Practice
- What is being tested?
- Interviews and Questionnaires
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 620 participants
- Where
- 2 sitesUnited States
- Study dates
- 11 Jul 2014to 31 Aug 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Participants recruited from Houston and Galveston areas.
Who may be able to join
- Men and women 55 to 80 years of age.
- Participants must speak English.
- Current smoker or quit smoking within the past 15 years.
Who cannot join
- 1. History of lung cancer.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
The University of Texas Medical Branch at Galveston
Galveston, Texas, 77555
- Recruiting
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
About this study
Official title: 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.
Read more
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.
- Conditions
- Health Knowledge, Attitudes, Practice
- Being tested
- Interviews, Questionnaires
- Keywords
- Cancer Prevention, Smokers, Quit smoking, Interviews, Questionnaires, Surveys, Lung cancer screening, Patient decision aid
- Medical subject headings
- Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InterviewsBehavioural
Interviews performed by study staff encompassing lung cancer screening and patient decision aids.
QuestionnairesBehavioural
Also called Surveys
Questionnaires completed after viewing patient decision aid video. Questionnaires also completed regarding lung cancer screening knowledge at first visit, then again in one month.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Interviews; Behavioral: Questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 Month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2014 (estimated)
- Study start11 Jul 2014
- Primary completion31 Aug 2028 (estimated)
- Study completion31 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Health Knowledge, Attitudes, PracticeStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 620 participants (estimated)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute
- Responsible party
- Sponsor
- Investigators
- Robert Volk, PHD, Study chair, M.D. Anderson Cancer CenterSuzanne Linder, PHD, Principal investigator, The University of Texas Medical Branch at GalvestonPaul Cinciripini, PHD, MS, BS, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02282969
- Sponsor's protocol ID
- PA14-0072
- Other IDs
- CER-1306-03385, NCI-2022-00832
- Status last verified
- Jul 2026
- First submitted
- 31 Oct 2014
- Last updated
- 16 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Promoting Informed Decisions About Lung Cancer Screening: Decision Aid Update and Measures Development
- ClinicalTrials.gov ID
- NCT02282969
- Acronym / sponsor ID
- PA14-0072
- Conditions
- Health Knowledge, Attitudes, Practice
- Keywords
- Cancer Prevention, Smokers, Quit smoking, Interviews, Questionnaires, Surveys, Lung cancer screening, Patient decision aid
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 620 participants (estimated)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute
- Study start
- 11 Jul 2014 (actual)
- Primary completion
- 31 Aug 2028 (estimated)
- Study completion
- 31 Aug 2028 (estimated)
- First posted
- 5 Nov 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lung Cancer Screening Decision Aids | – | Behavioral: Interviews, Behavioral: QuestionnairesParticipants 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. |
Who may qualify
- Ages
- 55 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Participants recruited from Houston and Galveston areas.
Key inclusion criteria (3 listed)
- Men and women 55 to 80 years of age.
- Participants must speak English.
- Current smoker or quit smoking within the past 15 years.
Key exclusion criteria (1 listed)
- 1. History of lung cancer.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| InterviewsInterviews performed by study staff encompassing lung cancer screening and patient decision aids. | Behavioural | Lung Cancer Screening Decision Aids |
| QuestionnairesAlso: SurveysQuestionnaires completed after viewing patient decision aid video. Questionnaires also completed regarding lung cancer screening knowledge at first visit, then again in one month. | Behavioural | Lung Cancer Screening Decision Aids |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2026.
- University of Texas MD Anderson Cancer Center WebsiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
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
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Health Knowledge, Attitudes, Practice, run by M.D. Anderson Cancer Center at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Robert Volk, PHD (713-563-2509, BVolk@mdanderson.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Informed Decisions About Lung Cancer Screening (Data from interviews and questionnaires reviewed to assess participant knowledge) (time frame: 1 Month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2026.