Lung Cancer Screening: A Multilevel Intervention

Study Overview
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Brief Summary
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The study will develop and test the feasibility of the Lung Cancer Assessment of Risk and Education (LungCARE) intervention to increase discussions about lung cancer screening between patients and physicians. This intervention will be designed to reach primary care patients and will be implemented at three levels of the healthcare structure: patient, physician, and system. The patient component includes a short lung cancer screening video and questions regarding screening preferences. Patients will receive immediate feedback in a report (patient report) that summarizes their lung cancer screening preferences and a handout summarizing the educational video. At the physician level, primary care physicians (PCPs) will receive a similar report (physician report), which will be delivered to them prior to the patient visit. The report contains additional information about documenting discussion related to risk, screening, and referrals in the electronic health record (EHR) system (system component). The investigators will develop the LungCARE intervention and have a comparison group that will receive usual care. Preliminary testing of LungCARE will occur via a randomized controlled trial (RCT) at the University of California, San Francisco, General Internal Medicine and Women's Health Primary Care clinics. The RCT will evaluate LungCARE among 50 PCPs and 120 high-risk current and former smoker patients. The investigators will determine whether the intervention is accepted by patients and physicians and whether patients who received LungCARE are more likely to discuss lung cancer screening with their physicians when compared to patients and physicians in the comparison group. The investigators will also determine whether the intervention affects knowledge of lung cancer and low-dose computed tomography (LDCT) screening, perception of risk, and worry about lung cancer in patients when compared to patients in the comparison group. The investigators expect their research to provide specific recommendations that will facilitate patient-physician discussions about LDCT screening and promote shared decision-making among patients and physicians.

Official Title
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Lung Cancer Screening: A Multilevel Intervention

Conditions
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Lung Cancer

Intervention / Treatment
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* Behavioral: LungCARE


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age 55-80 smoked at least 30 pack-years in lifetime if former smoker, quit smoking within the last 15 years English speaker no prior history of lung cancer did not have a lung cancer screening test within the last year PCP does not object to patient's participation have a scheduled visit at University of California, San Francisco (UCSF) internal medicine clinics. Exclusion Criteria: speaking a language other than English has a history of lung cancer had a lung cancer screening test within the last year PCP objects to patient's participation.

Ages Eligible for Study
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Minimum Age: 55 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: The intervention will involve a randomized control trial (RCT) with an intervention group that receives LungCARE and a comparison group that does not receive LungCARE.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: LungCARE Group<br>The intervention group will receive the LungCARE intervention | Behavioral: LungCARE<br>* The LungCARE intervention involves patient and PCP components. The patient component consists of watching a short, educational video, answering questions about lung cancer screening preferences, and receiving a patient report and handout. The PCP component consists of receiving a similar report (physician report) prior to the patient visit. This report is based on the patient's risk factors and lung cancer screening preferences. It contains additional information about documenting discussions related to risk, screening, and referrals in the electronic medical record system.<br>|
| No Intervention: Comparison Group<br>The comparison group will receive usual care. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Discussion of lung cancer risk and LDCT screening with PCP | Outcome 1 will be assessed in the follow-up survey, administered within one week following the clinic visit. All patients will answer the following yes/no questions: During your PCP visit, did you discuss...your personal risk of getting lung cancer/the risks and benefits of screening/how often people should be screened/whether you should be screened?, Did you discuss smoking cigarettes?, Did you talk about smoking and the risk of lung cancer?, and Did your doctor refer you to or order a test for lung cancer screening? Each question will be looked at individually and summed into a single score (0-7). Higher scores indicate an increased discussion of lung cancer risk and LDCT screening. Three months following the clinic visit, the investigators will review the electronic health records for all patients who signed HIPAA forms. Investigators will gather information about discussion of lung cancer risk and documentation, referrals, counseling, and receipt of LDCT screening. | Over 3 months | 
| Knowledge of lung cancer screening | Outcome 2 will be assessed in the follow-up survey, administered within one week following the clinic visit. All patients will answer true/false questions addressing various screening topics (e.g. annual lung cancer screening, false negative scans, false positive scans, who should be screened, and radiation exposure). Correct answers will be given a score of 1 and incorrect answers will be given a score of 0. Responses for each question will be added up to a single score, ranging between 0 and 10. Lower scores indicate lower knowledge and higher scores indicate higher knowledge. | Over one week | 
| Perception of lung cancer risk | Outcome 3 will be measured using an adapted Lerman Cancer Worry Scale. The following question will be asked over the course of one week, both prior to and following the clinic visit: In your opinion, compared to most people of your same age, sex, and race, what are you chances of getting lung cancer someday? Participants will use a five-point Likert scale (much higher [1], higher [2], about the same [3], lower [4], much lower [5]) to answer the questions. A higher score indicates a lower perception of lung cancer risk. Responses will be compared between the baseline and follow-up surveys. | Over one week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Worry about lung cancer | Outcome 4 will be measured using an adapted Lerman Cancer Worry Scale. The following questions will be asked over the course of one week, both prior to and following the clinic visit: How worried are you about getting lung cancer someday?, During the past month, how much has your worry about lung cancer affected your mood?, During the past month, how much has your worry about lung cancer affected your ability to perform your daily activities?, and During the past month, how often have you thought about your chances of getting lung cancer? Patients will use a 5-point Likert scale (a lot [1], somewhat [2], a little [3], not at all [4]) to answer the first 3 questions and a 4-point Likert scale (almost all the time [1], often [2], sometimes [3], not at all or rarely [4]) to answer the last question. Higher scores indicate a lower perception of risk. Each question will be examined individually. Responses will be compared between the baseline and follow-up surveys. | Over one week | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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randomized control trial, lung cancer risk assessment, shared decision making