Recruiting

Lung Cancer Screening

Sponsor:

University of Miami

Code:

NCT06124508

Conditions

Head and Neck Cancer

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Lung Cancer Screening Education

Semi-Structured Interview

Standard of Care Lung Cancer Screening Program

Study Details

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.

Conditions

Head and Neck Cancer

Study ID

NCT06124508

Start date

Apr 11, 2024

Status verified date

Apr, 2026

Completion date

Apr 30, 2029

Anticipated

Primary completion date

Apr 30, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Enrollment

44 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Screening

Interventions and Outcome Measures

Arms

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.

other: Standard of Care Control Group

Participants in this group will receive the standard of care treatment for up to two years.

Interventions

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.

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.

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.

Primary outcome measure

  • 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. [ Time Frame: 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. [ Time Frame: 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. [ Time Frame: 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. [ Time Frame: Up to 2 Years ]

Central Contacts and Locations

Central contacts

Coral Olazagasti, MD

305-243-4334cxo379@med.miami.edu

Locations

University of Miami

Recruiting

Miami, Florida, United States, 33136

Contacts

Coral Olazagasti, MD

305-243-4334cxo379@med.miami.edu

Principal Investigator:

Coral Olazagasti, MD

More Information

Sponsor

University of Miami

Last update posted

Apr 28, 2026

Last verified

Apr, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Miami on 2026-04-28.