Health Education Approach to Lung Screening (HEALS)
概览
- 阶段
- 不适用
- 干预措施
- Patient Navigation
- 疾病 / 适应症
- Lung Cancer
- 发起方
- Virginia Commonwealth University
- 入组人数
- 675
- 试验地点
- 3
- 主要终点
- Number of study patients who complete lung cancer screening (LCS) through the patient navigation process
- 状态
- 招募中
- 最后更新
- 上个月
概览
简要总结
Evaluate the impact of the patient navigation program on the proportion of patients who complete lung cancer screening (LCS), defined as undergoing a low dose computed tomography (LDCT)
详细描述
This is a single-arm study of a patient navigation intervention to increase access to lung cancer screening (LCS).
研究者
入排标准
入选标准
- •Meets current USPSTF guidelines for lung cancer screening (LCS)
- •20 pack-year smoking history Note: A pack-year is a way of calculating how much a person has smoked in their lifetime.
- •One pack-year is the equivalent of smoking an average of 20 cigarettes-1 pack-per day for a year.
- •Currently smokes or has quit smoking within the past 15 years
- •Identifies as Black or African-American Note: Both Hispanic/Latino and Non-Hispanic/Latino patients are eligible as long as they also identify as Black or African-American (eg, Afro-Latino).
- •Willing to complete all navigation-related study activities
- •Able to understand and the willingness to sign a written informed consent document
排除标准
- •A patient who meets any of the following exclusion criteria is ineligible to participate in the study:
- •Known history of cancer (except squamous cell skin cancer), or coughing up blood in the past 5 years, as reported by the individual
- •Has undergone a previous lung cancer screening
- •Inability to speak English
- •Medical, psychological, or social condition that, in the opinion of the investigator, may increase the patient's risk or limit the patient's adherence with study requirements
研究组 & 干预措施
Patient Navigation
Centralized patient navigators will be trained to help patients navigate the clinical, logistical, and financial aspects of LCS. Navigators employ case management approaches based on social work principles. The experience of patient navigation will be tailored to the individual participant
干预措施: Patient Navigation
结局指标
主要结局
Number of study patients who complete lung cancer screening (LCS) through the patient navigation process
时间窗: 2 weeks to 4 months following day 1, varies by participant
Evaluate the impact of the patient navigation program on the number of patients who complete lung cancer screening (LCS), defined as undergoing a low dose computed tomography (LDCT).
次要结局
- Assess the impact of the patient navigation program on patient health-related quality of life after navigation intervention.(2 weeks to 4 months following day 1, varies by participant)
- Assess the feasibility and acceptability of the patient navigation program(2 weeks to 4 months following day 1, varies by participant)
- Assess the impact of the patient navigation program on patient health-related quality of life at baseline.(Day 1)
- Assess the impact of the patient navigation program on patient financial distress(2 weeks to 4 months following day 1, varies by participant)
- Assess the feasibility and acceptability of the patient navigation program(Day 1)
- Assess the impact of the patient navigation program on patient financial distress(Day 1)