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

Официальное название

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

Обзор

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.

Вмешательства

• Поведенческое 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.
• Поведенческое 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.
• Поведенческое 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.

Первичные конечные точки

• 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. [Срок оценки: 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. [Срок оценки: 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. [Срок оценки: 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. [Срок оценки: Up to 2 Years]

Вторичные конечные точки (1)

• Change in proportion of participants that undergo early detection lung cancer screening [Срок оценки: Baseline, 1 Year]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Скрининг

Центры проведения

США · 1 центр

• University of Miami — Miami

Идентификаторы

NCT: NCT06124508 · 20220746 · K12CA226330

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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