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The goal of the study is to adapt and test a participant decision aid about lung cancer screening for use with patients in theHarris Health System (HHS).
The study has two phases. In the first phase, the investigators will conduct a cultural and linguistic adaptation of a patient decision aid video on lung cancer screening for use with patients with low health literacy in English and Spanish. They will produce adapted decision aid videos and written educational materials about lung cancer screening. They will survey providers about their lung cancer screening practices, conduct focus groups to learn what patients want to know about screening, and perform cognitive interviews with patients to make sure the adapted videos and educational materials are easy to understand.
In the second phase, the investigators will test the adapted lung cancer screening decision aid videos in English and Spanish to determine acceptability and impact of the aids on decision making outcomes. Patients will be randomized to evaluate an adapted video decision aid intervention or a control condition.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Needs Assessment: Provider Survey (Aim 1) | Other | Up to 200 physicians and other health professionals |
|
| Needs Assessment: Patient/Family member Focus Groups (Aim 1) | Other | Up to 20 participants who speak English or Spanish |
|
| Decision Aid Adaptation (Patient Cognitive Interviews (Aim 1) | Other | Up to 40 participants who speak English or Spanish |
|
| Pilot Study: Intervention Patients (Aim 2) | Experimental | Up to 50 participants (25 English speakers, 25 Spanish speakers) |
|
| Pilot Study: Control Patients (Aim 2) | Placebo Comparator | Up to 50 participants (25 English speakers, 25 Spanish speakers) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Surveys | Other | Investigators will answer surveys about their lung cancer screening practices |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety and Adverse Events (AEs). | Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0 | Through study completion; an average of 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Robert Volk, PHD | Contact | (713) 563-2509 | bvolk@mdanderson.org |
| Name | Affiliation | Role |
|---|---|---|
| Robert Vok, PHD | M.D. Anderson Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Texas M. D. Anderson Cancer Center | Recruiting | Houston | Texas | 77030 | United States |
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| Label | URL |
|---|---|
| MD Anderson Cancer Center Website | View source |
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| Focus groups | Other | Participants will participate in focus groups about information they need in order to decide about lung cancer screening |
|
| Cognitive Interviews | Other | Participants will participate in interviews about their understanding of the adapted video script |
|
| Lung cancer screening decision aid video | Behavioral | Participants take surveys before and after watching the intervention video |
|
| Colon cancer screening video | Behavioral | Participants take surveys before and after watching the control video |
|
| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D011795 | Surveys and Questionnaires |
| D017144 | Focus Groups |
| ID | Term |
|---|---|
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |
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