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Clinical Trials/NCT06124508
NCT06124508
Recruiting
Not Applicable

GUIAR: PromotinG Lung Cancer screenIng Awareness and Implementation in Hispanics/Latinx Head and Neck canceR Survivors

University of Miami2 sites in 1 country44 target enrollmentApril 11, 2024

Overview

Phase
Not Applicable
Intervention
Standard of Care Lung Cancer Screening Program
Conditions
Head and Neck Cancer
Sponsor
University of Miami
Enrollment
44
Locations
2
Primary Endpoint
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.
Status
Recruiting
Last Updated
4 days ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
April 11, 2024
End Date
April 30, 2029
Last Updated
4 days ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Coral Olazagasti

Assistant Professor of Clinical

University of Miami

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.

Arms & Interventions

Standard of Care Control Group

Participants in this group will receive the standard of care treatment for up to two years.

Intervention: Standard of Care Lung Cancer Screening Program

Lung Cancer Screening Education Group

Participants in this group will receive intensive lung cancer screening and tobacco cessation education for up to two years.

Intervention: Lung Cancer Screening Education

Lung Cancer Screening Education Group

Participants in this group will receive intensive lung cancer screening and tobacco cessation education for up to two years.

Intervention: Semi-Structured Interview

Lung Cancer Screening Education Group

Participants in this group will receive intensive lung cancer screening and tobacco cessation education for up to two years.

Intervention: Standard of Care Lung Cancer Screening Program

Outcomes

Primary Outcomes

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' 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' 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' 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.

Secondary Outcomes

  • Change in proportion of participants that undergo early detection lung cancer screening(Baseline, 1 Year)

Study Sites (2)

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