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NCT Number: NCT06124508

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.

Recruiting

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Key information

Conditions

Head and Neck Cancer Head and Neck Neoplasms Neoplasms Neoplasms by Site

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Miami

Miami, Florida, 33136, United States

Location status: Recruiting

Location contact

Coral Olazagasti, MD

CONTACT

[email protected]

305-243-4334

Coral Olazagasti, MD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Lung Cancer Screening Education

Behavioral

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

Behavioral

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

Behavioral

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 outcomes

  1. 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

    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.

  2. 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

    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.

  3. 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

    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.

  4. 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

    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 outcomes

  1. Change in proportion of participants that undergo early detection lung cancer screening

    Time frame: Baseline, 1 Year

    The change in the proportion of participants that undergo early detection lung cancer screening will be reported.

Study contacts

Contact information is provided by the study sponsor or research team.

Coral Olazagasti, MD

CONTACT

[email protected]

305-243-4334

Sponsors and collaborators

Lead sponsor

University of Miami

Other

Collaborators

  • LUNGevity Foundation
  • National Cancer Institute (NCI)

Registry information

Official study title

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

Acronym: GUIAR

Important dates

Study start
2024
Primary completion
2029
Study completion
2029
First posted
Nov 9, 2023
Registry last updated
Apr 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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