Head and Neck Cancer
Conditions
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.
Interventions
BEHAVIORALLung 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.
BEHAVIORALSemi-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.
BEHAVIORALStandard 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.
Sponsors
University of Miami
LUNGevity Foundation
National Cancer Institute (NCI)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
SINGLE (Subject)
Masking description
All participants will be randomized in a 1:1 ratio to the intervention or control arm via a blinded systematic randomization.
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. | 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. | 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. | 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. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in proportion of participants that undergo early detection lung cancer screening | Baseline, 1 Year | The change in the proportion of participants that undergo early detection lung cancer screening will be reported. |
Countries
United States
Contacts
CONTACTCoral Olazagasti, MD
PRINCIPAL_INVESTIGATORCoral Olazagasti, MD
University of Miami
Outcome results
None listed