Clinical trial NCT06124508: PromotinG Lung Cancer screenIng Awareness and Implementation in Hispanics/Latinx Head and Neck canceR Survivors
Official title: GUIAR: PromotinG Lung Cancer screenIng Awareness and Implementation in Hispanics/Latinx Head and Neck canceR Survivors
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Head and Neck Cancer
Lead sponsor: University of Miami
Sponsor class: OTHER
Collaborators: name: LUNGevity Foundation
name: National Cancer Institute (NCI)
First posted: 2023-11-09
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

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.


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.

Primary outcomes:
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.
timeFrame: Up to 2 Years
measure: Proportion of participants' awareness of lung cancer screening recommendations as measured by the University of Miami lung cancer screening program survey questionnaire.
timeFrame: Up to 2 Years
measure: 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.
timeFrame: Up to 2 Years
measure: Proportion of participants' perception of lung cancer screening recommendations as measured by the University of Miami lung cancer screening program survey questionnaire.
timeFrame: Up to 2 Years
Secondary outcomes:
measure: Change in proportion of participants that undergo early detection lung cancer screening
timeFrame: Baseline, 1 Year
Other outcomes:
Locations:
city: Miami
country: United States
facility: University of Miami
state: Florida
Study officials:
affiliation: University of Miami
name: Coral Olazagasti, MD
role: PRINCIPAL_INVESTIGATOR
References: