Lung Cancer Screening in High-risk Black Women

Study Overview
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Brief Summary
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The goal of this research study is to study U.S. Black women with a history of smoking to examine the feasibility, acceptability, and performance of low-dose computed tomography (LDCT) screening among this population. The name of the intervention used in this research study is: Low-dose computed tomography (radiologic scan) chest scan

Detailed Description
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The goal of this single-arm pilot research study is to evaluate the feasibility and acceptability of low-dose computed tomography (LDCT) screening for lung cancer among U.S. Black women with a history of smoking. LDCT screening is currently the only recommended way to screen for lung cancer among high-risk individuals. However, the majority of Black women at high-risk for lunch cancer are currently ineligible for lung cancer screening. Study procedures include screening for eligibility, completion of questionnaires, and a LDCT screening test. Participation in this study is expected to last up to 3 months. It is expected about 900 people will participate in this study.

Official Title
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Evaluating the Feasibility of Lung Cancer Screening in High-risk Black Women

Conditions
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Lung Cancer, Lung Carcinoma

Intervention / Treatment
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* Procedure: Low-dose Computed Tomography


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Self-identified Black women. Have a self-reported history of smoking. No restriction will be placed on the number of smoking pack years participants must have nor the number of years former smokers must have quit smoking. Aged >= 50 years. Exclusion Criteria: Individuals with a history of lung cancer. Individuals with symptoms suggestive of lung cancer. We will evaluate whether women have symptoms suggestive of lung cancer by administering an online screening questionnaire, which will ask whether they have experienced shortness of breath, whether they become easily winded, and whether they have had a chronic cough within the last 12 weeks that has not improved. Women who select that they have any one of these symptoms will be advised to follow up with their primary doctor and will not be eligible to participate in the study. Individuals with pneumonia or acute respiratory infection within 12 weeks prior to enrollment that was treated with antibiotics.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Screening: Low-Dose Computed Tomography Screening<br>Participants will undergo study procedures as outlined: Complete questionnaires pre- and post- low-dose computed tomography (LDCT) test. Visit Massachusetts General Hospital facility for a LDCT screening test. | Procedure: Low-dose Computed Tomography<br>* Per standard care<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of Enrolled Participants | Primary endpoint is feasibility. Feasibility is defined as the percentage of invited participants of the Black Women's Health Study (BWHS) who enroll. | At enrollment | 
| Proportion of Participants with Positive Low-dose Computed Tomography Test | The percentage of participants who have a positive low-dose computed tomography test will be evaluated. This percentage will be compared to the Black women randomized to the low-dose computed tomography screening arm in the National Lung Screening Trial (historical control). | At 3 months | 
| Proportion of Participants Diagnosed with Invasive Lung Cancer | The proportion of participants with a lung cancer diagnosis post-low-dose computed tomography screening test will be compared to Black women randomized to the LDCT screening arm in the National Lung Screening Trial (historical control). | At 6 months | 
| Distribution of Lung Imaging Reporting and Data System (Lung-RADS) Scores | The distribution of Lung-RADS scores among participants will be evaluated and compared to the distribution of Lung-RADS scores among Black women randomized to the LDCT screening arm in the National Lung Screening Trial (historical control). | At 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of Participants Who Undergo Invasive Diagnostic Procedures | The proportion of participants who undergo invasive diagnostic procedures will be evaluated and compared to the proportion of Black women randomized to the LDCT screening arm in the National Lung Screening Trial (historical control) who underwent invasive diagnostic procedures. | At 6 months | 
| Proportion of Participants Who Have a Complication Resulting from an Invasive Diagnostic Procedure Performed for a Positive Low-dose Computed Tomography Scan | The proportion of participants who have a complication resulting from an invasive diagnostic procedure performed for a positive low-dose computed tomography scan will be evaluated. This proportion will be compared to the proportion of Black women randomized to the low-dose computed tomography screening arm in the National Lung Screening Trial (historical control) who had a complication resulting from an invasive diagnostic procedure performed for a positive low-dose computed tomography scan. | At 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Lung Cancer, Lung Carcinoma