GUIAR: PromotinG Lung Cancer screenIng Awareness and Implementation in Hispanics/Latinx Head and Neck canceR Survivors
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 44
- 试验地点
- 2
- 主要终点
- 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.
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- Single (Participant)
盲法说明
All participants will be randomized in a 1:1 ratio to the intervention or control arm via a blinded systematic randomization.
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Standard of Care Control Group
Participants in this group will receive the standard of care treatment for up to two years.
干预措施: Standard of Care Lung Cancer Screening Program (Behavioral)
Lung Cancer Screening Education Group
Participants in this group will receive intensive lung cancer screening and tobacco cessation education for up to two years.
干预措施: Lung Cancer Screening Education (Behavioral)
Lung Cancer Screening Education Group
Participants in this group will receive intensive lung cancer screening and tobacco cessation education for up to two years.
干预措施: Semi-Structured Interview (Behavioral)
Lung Cancer Screening Education Group
Participants in this group will receive intensive lung cancer screening and tobacco cessation education for up to two years.
干预措施: Standard of Care Lung Cancer Screening Program (Behavioral)
结局指标
主要结局
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.
时间窗: 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.
时间窗: 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.
时间窗: 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.
时间窗: 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.
次要结局
- Change in proportion of participants that undergo early detection lung cancer screening(Baseline, 1 Year)
研究者
Coral Olazagasti
Assistant Professor of Clinical
University of Miami