Clinical trial NCT05898594: Lung Cancer Screening in High-risk Black Women
Official title: Evaluating the Feasibility of Lung Cancer Screening in High-risk Black Women
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Lung Cancer
Lung Carcinoma
Keywords: Lung Cancer
Lung Carcinoma
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: Agency for Healthcare Research and Quality (AHRQ)
First posted: 2023-06-12
Enrollment: 900
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief summary: 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: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Proportion of Enrolled Participants
timeFrame: At enrollment
measure: Proportion of Participants with Positive Low-dose Computed Tomography Test
timeFrame: At 3 months
measure: Proportion of Participants Diagnosed with Invasive Lung Cancer
timeFrame: At 6 months
measure: Distribution of Lung Imaging Reporting and Data System (Lung-RADS) Scores
timeFrame: At 3 months
Secondary outcomes:
measure: Proportion of Participants Who Undergo Invasive Diagnostic Procedures
timeFrame: At 6 months
measure: Proportion of Participants Who Have a Complication Resulting from an Invasive Diagnostic Procedure Performed for a Positive Low-dose Computed Tomography Scan
timeFrame: At 6 months
Other outcomes:
Locations:
city: Chicago
country: United States
facility: University of Chicago
state: Illinois
city: Boston
country: United States
facility: Massachusetts General Hospital Cancer Center
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Chi Fu Jeffrey Yang, MD
role: PRINCIPAL_INVESTIGATOR
References: