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

NCT ID: NCT06124508

Last Updated: 2025-04-27

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 44 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-04-11
• Study Completion Date: 2026-04-30

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 Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SCREENING
• Blinding Strategy: SINGLE

Study Groups

Lung Cancer Screening Education Group

Participants in this group will receive intensive lung cancer screening and tobacco cessation education for up to two years.

Group Type: EXPERIMENTAL

Lung Cancer Screening Education

Intervention Type: 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

Intervention Type: 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

Intervention Type: 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.

Standard of Care Control Group

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

Group Type: OTHER

Standard of Care Lung Cancer Screening Program

Intervention Type: 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.

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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

LUNGevity Foundation

OTHER

Sponsor Role: collaborator

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

University of Miami

OTHER

Sponsor Role: lead

Responsible Party

Coral Olazagasti

Assistant Professor of Clinical

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Coral Olazagasti, MD

Role: PRINCIPAL_INVESTIGATOR

University of Miami

Locations

University of Miami

Miami, Florida, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Coral Olazagasti, MD

Role: CONTACT

cxo379@med.miami.edu

305-243-4334

Facility Contacts

Coral Olazagasti, MD

Role: primary

cxo379@med.miami.edu

305-243-4334

Other Identifiers

K12CA226330

Identifier Type: NIH

Identifier Source: secondary_id

View Link

20220746

Identifier Type: -

Identifier Source: org_study_id