Recruiting NCT06124508
PromotinG Lung Cancer screenIng Awareness and Implementation in Hispanics/Latinx Head and Neck canceR Survivors
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Lung Cancer Screening Education, Semi-Structured Interview, Standard of Care Lung Cancer Screening Program.
- Who it may be relevant to
- Registry conditions: Head and Neck Cancer. Basic parameters: 18 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
GUIAR: PromotinG Lung Cancer screenIng Awareness and Implementation in Hispanics/Latinx Head and Neck canceR Survivors
Overview
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.
Interventions
- Behavioral 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. - 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. - 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.
Primary outcome measures
- 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]
- 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]
- 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]
- 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]
Secondary outcome measures (1)
- Change in proportion of participants that undergo early detection lung cancer screening [Time frame: Baseline, 1 Year]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Screening
Study locations
United States · 1 center
- University of Miami — Miami
Identifiers
NCT: NCT06124508 · 20220746 · K12CA226330