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Trial Title:
PromotinG Lung Cancer screenIng Awareness and Implementation in Hispanics/Latinx Head and Neck canceR Survivors
NCT ID:
NCT06124508
Condition:
Head and Neck Cancer
Conditions: Official terms:
Head and Neck Neoplasms
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Screening
Masking:
Single (Participant)
Masking description:
All participants will be randomized in a 1:1 ratio to the intervention or control arm via
a blinded systematic randomization.
Intervention:
Intervention type:
Behavioral
Intervention name:
Lung Cancer Screening Education
Description:
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.
Arm group label:
Lung Cancer Screening Education Group
Intervention type:
Behavioral
Intervention name:
Semi-Structured Interview
Description:
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.
Arm group label:
Lung Cancer Screening Education Group
Intervention type:
Behavioral
Intervention name:
Standard of Care Lung Cancer Screening Program
Description:
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.
Arm group label:
Lung Cancer Screening Education Group
Arm group label:
Standard of Care Control Group
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.
Criteria for 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
80 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
University of Miami
Address:
City:
Miami
Zip:
33136
Country:
United States
Status:
Recruiting
Contact:
Last name:
Coral Olazagasti, MD
Phone:
305-243-4334
Email:
cxo379@med.miami.edu
Investigator:
Last name:
Coral Olazagasti, MD
Email:
Principal Investigator
Start date:
April 11, 2024
Completion date:
April 30, 2026
Lead sponsor:
Agency:
University of Miami
Agency class:
Other
Collaborator:
Agency:
LUNGevity Foundation
Agency class:
Other
Collaborator:
Agency:
National Cancer Institute (NCI)
Agency class:
NIH
Source:
University of Miami
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06124508
