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

NCT06124508 | Recruiting

• 2 other identifiers: 20220746K12CA226330
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (1)

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

  Baseline, 1 Year

Study Arms (2)

Lung Cancer Screening Education Group

EXPERIMENTAL

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

Behavioral: Lung Cancer Screening Education; Behavioral: Semi-Structured Interview; Behavioral: Standard of Care Lung Cancer Screening Program

Standard of Care Control Group

OTHER

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

Behavioral: Standard of Care Lung Cancer Screening Program

Interventions

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.

Lung Cancer Screening Education Group

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.

Lung Cancer Screening Education Group

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.

Lung Cancer Screening Education Group; Standard of Care Control Group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Miami: lead
• LUNGevity Foundation: collaborator
• National Cancer Institute (NCI): collaborator

Study Sites (1)

University of Miami

Miami, Florida, 33136, United States

RECRUITING

MeSH Terms

Conditions

Head and Neck Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms

Study Officials

• Coral Olazagasti, MD

  University of Miami

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Coral Olazagasti, MD

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: All participants will be randomized in a 1:1 ratio to the intervention or control arm via a blinded systematic randomization.
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Clinical

Study Record Dates

• First Submitted: November 3, 2023
• First Posted: November 9, 2023
• Study Start: April 11, 2024
• Primary Completion (Estimated): April 30, 2029
• Study Completion (Estimated): April 30, 2029
• Last Updated: April 28, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)