PromotinG Lung Cancer screenIng Awareness and Implementation in Hispanics/Latinx Head and Neck canceR Survivors

Not Applicable

Recruiting

• Conditions: Head and Neck Cancer
• Interventions: Behavioral: Lung Cancer Screening Education; Behavioral: Semi-Structured Interview; Behavioral: Standard of Care Lung Cancer Screening Program

• Registration Number: NCT06124508
• Lead Sponsor: University of Miami

Brief Summary

The purpose of this study is to assess the awareness of eligibility of lung cancer screening in Hispanic/LatinX Head and Neck Cancer (HNC) survivors using a survey questionnaire; and to understand the barriers to screening using qualitative interviews.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-11-03
• Study First Submitted QC: 2023-11-03
• Study First Posted: 2023-11-09
• Study Start: 2024-04-11
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-25
• Last Update Posted: 2025-04-27
• Primary Completion: 2026-04-30
• Study Completion: 2026-04-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 44

Inclusion Criteria

• Participants must be able to understand, and sign informed consent form.
• Age ≥ 18 years.
• Participants must self-identify as Hispanic/LatinX.
• Individuals must be head and neck cancer survivors (treated locally with surgery, radiation alone, or definitive chemoradiation ≥ 5 years earlier and have no signs/symptoms to suggest recurrence of disease).
• Subjects that meet lung cancer (LC) screening eligibility according to United States Preventive Services Task Force (USPSTF21) and/or National Comprehensive Cancer Network (NCCN). For patients with a history of head and neck cancers, the NCCN recommends annual screening with low dose computerized tomography (LDCT) in those who have had a history of 20 pack years of smoking or more. USPSTF21 LC screening eligibility includes adults ages 50-80 that are current smoker or former smokers that quit within 15 years and have a 20 pack-year history or more of smoking.

Exclusion Criteria

• Individuals with pre-established diagnosis of lung cancer.
• Participants with current diagnosis of any active malignancy.
• Subjects that had undergone lung imaging within previous 3 years.
• Pregnant or nursing mothers.
• Individuals that received head and neck related treatment less than 5 years before screening.
• Individuals with < 20 pack year history of smoking.
• Subjects with previous history of distant metastatic head and neck cancer.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Lung Cancer Screening Education Group	Semi-Structured Interview	Participants in this group will receive intensive lung cancer screening and tobacco cessation education for up to two years.
Lung Cancer Screening Education Group	Standard of Care Lung Cancer Screening Program	Participants in this group will receive intensive lung cancer screening and tobacco cessation education for up to two years.
Lung Cancer Screening Education Group	Lung Cancer Screening Education	Participants in this group will receive intensive lung cancer screening and tobacco cessation education for up to two years.
Standard of Care Control Group	Standard of Care Lung Cancer Screening Program	Participants in this group will receive the standard of care treatment for up to two years.

Primary Outcome Measures

Name	Time	Method
Proportion of participants' perception of the risk of second primary lung cancer as measured by the University of Miami lung cancer screening program survey questionnaire.	Up to 2 Years	The proportion of participants' perception of the risk of second primary lung cancer will be assessed via the University of Miami lung cancer screening program survey questionnaire. Perception of the risk of second primary lung cancer will be reported as the proportion of participants that indicated 'Yes' and 'No' on the survey questionnaire.
Proportion of participants' awareness of lung cancer screening recommendations as measured by the University of Miami lung cancer screening program survey questionnaire.	Up to 2 Years	The proportion of participants' awareness of lung cancer screening recommendations will be assessed via the University of Miami lung cancer screening program survey questionnaire. Awareness of the lung cancer screening recommendations will be reported as the proportion of participants that indicated 'Yes' and 'No' on the survey questionnaire.
Proportion of participants' awareness of the risk of second primary lung cancer as measured by the University of Miami lung cancer screening program survey questionnaire.	Up to 2 Years	The proportion of participants' awareness of the risk of second primary lung cancer will be assessed via the University of Miami lung cancer screening program survey questionnaire. Awareness of the risk of second primary lung cancer will be reported as the proportion of participants that indicated 'Yes' and 'No' on the survey questionnaire.
Proportion of participants' perception of lung cancer screening recommendations as measured by the University of Miami lung cancer screening program survey questionnaire.	Up to 2 Years	The proportion of participants' perception of lung cancer screening recommendations will be assessed via the University of Miami lung cancer screening program survey questionnaire. Perception of the lung cancer screening recommendations will be reported as the proportion of participants that indicated 'Yes' and 'No' on the survey questionnaire.

Secondary Outcome Measures

Name	Time	Method
Change in proportion of participants that undergo early detection lung cancer screening	Baseline, 1 Year	The change in the proportion of participants that undergo early detection lung cancer screening will be reported.

Trial Locations

Locations (1)

University of Miami; 🇺🇸 Miami, Florida, United States