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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Head and Neck Cancer
• Intervention / Treatment: Behavioral: Lung Cancer Screening Education; Behavioral: Semi-Structured Interview; Behavioral: Standard of Care Lung Cancer Screening Program

• Study Type: Interventional
• Enrollment (Estimated): 44
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Coral Olazagasti, MD; Phone Number: 305-243-4334; Email: cxo379@med.miami.edu

Study Locations

• United States
  • Florida
    • Miami, Florida, United States, 33136
      • Recruiting
      • University of Miami
      • Contact: Coral Olazagasti, MD; Phone Number: 305-243-4334; Email: cxo379@med.miami.edu
      • Principal Investigator: Coral Olazagasti, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Lung Cancer Screening Education Group; Participants in this group will receive intensive lung cancer screening and tobacco cessation education for up to two years.	Behavioral: Lung Cancer Screening Education; Tailored lung cancer screening education will consist of an annual, in-person 60 minute visit of lung cancer screening education in the participant's native language with material in layman's terms about the importance of lung cancer screening, tobacco cessation, and the risk of developing a second primary lung cancer.; Behavioral: Semi-Structured Interview; Participants will undergo an annual, in-person or virtual, semi-structured interviews to understand barriers and perception towards screening and cultural competencies to increase adherence to lung cancer screening. The interviews will last approximately 30 minutes at each visit.; Behavioral: Standard of Care Lung Cancer Screening Program; Participants will receive standard of care referral to the University of Miami's Lung Cancer Screening Program. The standard education includes a one-time, in-person or virtual 60-minute visit with the Advanced Practice Registered Nurse (APRN) to review educational material about lung cancer screening and tobacco cessation guidelines, and to discuss the risks versus benefits of undergoing screening.
Other: Standard of Care Control Group; Participants in this group will receive the standard of care treatment for up to two years.	Behavioral: Standard of Care Lung Cancer Screening Program; Participants will receive standard of care referral to the University of Miami's Lung Cancer Screening Program. The standard education includes a one-time, in-person or virtual 60-minute visit with the Advanced Practice Registered Nurse (APRN) to review educational material about lung cancer screening and tobacco cessation guidelines, and to discuss the risks versus benefits of undergoing screening.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	Up to 2 Years
Proportion of participants' awareness of lung cancer screening recommendations as measured by the University of Miami lung cancer screening program survey questionnaire.	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.	Up to 2 Years
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.	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.	Up to 2 Years
Proportion of participants' perception of lung cancer screening recommendations as measured by the University of Miami lung cancer screening program survey questionnaire.	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.	Up to 2 Years

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University of Miami
• Collaborators: National Cancer Institute (NCI); LUNGevity Foundation
• Investigators: Principal Investigator: Coral Olazagasti, MD, University of Miami

Study record dates

Study Major Dates

• Study Start (Actual): April 11, 2024
• Primary Completion (Estimated): April 30, 2029
• Study Completion (Estimated): April 30, 2029

Study Registration Dates

• First Submitted: November 3, 2023
• First Submitted That Met QC Criteria: November 3, 2023
• First Posted (Actual): November 9, 2023

Study Record Updates

• Last Update Posted (Actual): April 28, 2026
• Last Update Submitted That Met QC Criteria: April 22, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Head and Neck Neoplasms
• Other Study ID Numbers: 20220746; K12CA226330 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No