Head and Neck CancerGUIARNCT06124508
PromotinG Lung Cancer screenIng Awareness and Implementation in Hispanics/Latinx Head and Neck canceR Survivors
A study testing Lung Cancer Screening Education and Semi-Structured Interview in people with Head and Neck Cancer, run by University of Miami at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Head and Neck Cancer
- What is being tested?
- Lung Cancer Screening Education and Semi-Structured Interview
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Apr 2024to 30 Apr 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Miami
Miami, Florida, 33136
Coral Olazagasti, MD, 305-243-4334, cxo379@med.miami.edu
Coral Olazagasti, MD
About this study
Official title: 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.
- Conditions
- Head and Neck Cancer
- Being tested
- Lung Cancer Screening Education, Semi-Structured Interview, Standard of Care Lung Cancer Screening Program
- Medical subject headings
- Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lung Cancer Screening EducationBehavioural
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 InterviewBehavioural
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 ProgramBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Standard of Care Lung Cancer Screening Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Up to 2 Years
Secondary outcomes (1)
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.
Measured: Baseline, 1 Year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2023
- Study start11 Apr 2024
- Primary completion30 Apr 2029 (estimated)
- Study completion30 Apr 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck CancerStudies of the same condition, open and under way.
- More trials run by University of MiamiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Collaborators
- LUNGevity Foundation, National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Coral Olazagasti, University of Miami
- Investigators
- Coral Olazagasti, MD, Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06124508
- Sponsor's protocol ID
- 20220746
- Other IDs
- K12CA226330
- Acronym
- GUIAR
- Status last verified
- Apr 2026
- First submitted
- 3 Nov 2023
- Last updated
- 28 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- GUIAR: PromotinG Lung Cancer screenIng Awareness and Implementation in Hispanics/Latinx Head and Neck canceR Survivors
- ClinicalTrials.gov ID
- NCT06124508
- Acronym / sponsor ID
- GUIAR / 20220746
- Conditions
- Head and Neck Cancer
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Collaborators
- LUNGevity Foundation, National Cancer Institute (NCI)
- Study start
- 11 Apr 2024 (actual)
- Primary completion
- 30 Apr 2029 (estimated)
- Study completion
- 30 Apr 2029 (estimated)
- First posted
- 9 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lung Cancer Screening Education Group | Experimental | Behavioral: Lung Cancer Screening Education, Behavioral: Semi-Structured Interview, Behavioral: Standard of Care Lung Cancer Screening ProgramParticipants in this group will receive intensive lung cancer screening and tobacco cessation education for up to two years. |
| Standard of Care Control Group | Other | Behavioral: Standard of Care Lung Cancer Screening ProgramParticipants in this group will receive the standard of care treatment for up to two years. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lung Cancer Screening EducationTailored 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. | Behavioural | Lung Cancer Screening Education Group |
| Semi-Structured InterviewParticipants 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. | Behavioural | Lung Cancer Screening Education Group |
| Standard of Care Lung Cancer Screening ProgramParticipants 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. | Behavioural | Lung Cancer Screening Education Group, Standard of Care Control Group |
Primary outcome
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.
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.
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.
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.
1 secondary outcome
Change in proportion of participants that undergo early detection lung cancer screening
Time frame: Baseline, 1 Year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Coral Olazagasti, MD principal investigator
University of Miami
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lung Cancer Screening Education and Semi-Structured Interview in people with Head and Neck Cancer, run by University of Miami at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Coral Olazagasti, MD (305-243-4334, cxo379@med.miami.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2026; AzTrials last refreshed its copy on 7 Nov 2026.