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| ID | Type | Description | Link |
|---|---|---|---|
| CER-1306-03385 | Other Grant/Funding Number | Patient Centered Outcomes Research Institute | |
| NCI-2022-00832 | Other Identifier | Clinical Trials Reporting Program (CTRP) |
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| Name | Class |
|---|---|
| Patient-Centered Outcomes Research Institute | OTHER |
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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.
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:
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Interviews | Behavioral | Interviews performed by study staff encompassing lung cancer screening and patient decision aids. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
1. History of lung cancer.
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Participants recruited from Houston and Galveston areas.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Robert Volk, PHD | Contact | 713-563-2509 | BVolk@mdanderson.org |
| Name | Affiliation | Role |
|---|---|---|
| Robert Volk, PHD | M.D. Anderson Cancer Center | Study Chair |
| Suzanne Linder, PHD | The University of Texas Medical Branch at Galveston | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Texas Medical Branch at Galveston | Recruiting | Galveston | Texas | 77555 | United States | |
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| Label | URL |
|---|---|
| University of Texas MD Anderson Cancer Center Website | View source |
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| ID | Term |
|---|---|
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D007407 | Interviews as Topic |
| D011795 | Surveys and Questionnaires |
| ID | Term |
|---|---|
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
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| Questionnaires | Behavioral | Questionnaires completed after viewing patient decision aid video. Questionnaires also completed regarding lung cancer screening knowledge at first visit, then again in one month. |
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| Paul Cinciripini, PHD, MS, BS |
| M.D. Anderson Cancer Center |
| Principal Investigator |
| University of Texas MD Anderson Cancer Center |
| Recruiting |
| Houston |
| Texas |
| 77030 |
| United States |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |