Randomised Controlled Trial to Test Novel Invitation Methods and Materials Targeted to Increase Informed Uptake of Lung Cancer Screening in Individuals at High Risk of Lung Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,997
- 试验地点
- 2
- 主要终点
- Attendance to pre-allocated Lung Health Check Appointment
研究概览
简要总结
This study tests the impact of a novel invitation strategy on attendance rates to a pre-lung cancer screening lung health check appointment. Patients will be individually randomised (1:1) to receive either control invitation materials or intervention invitation materials. Those who attend will undergo a "lung health check" and be invited to a baseline screening scan if eligibility criteria are fulfilled.
详细描述
Lung cancer screening using low dose computed tomography (LDCT) scans has been shown to reduce lung cancer-specific and all-cause mortality in a large United States (US) trial, and screening is now being carried out in the US. Studies have shown that participation rates are invariably low, particularly by current smokers and those from socioeconomically deprived backgrounds; groups within which high risk candidates are overrepresented.
In this study the investigators aim to improve informed participation in screening and reduce socioeconomic and smoking-related biases in participation. The investigators will identify individuals at high risk of lung cancer; specifically adults aged 60-75 who are current or recent former smokers. Eligible individuals will be invited by their General Practitioner to a "lung health check appointment" via one of two randomly allocated invitation strategies. The control materials will be similar to those used by UK screening programmes for other cancer types. The intervention materials have been designed to reduce barriers to participation among smokers from low socioeconomic status backgrounds.
Those that attend will have a lung cancer risk assessment, and if confirmed to be eligible, will undergo a baseline LDCT scan. Data will be collected with respect to demographics, risk and various clinical and radiological outcomes.
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 (Outcomes Assessor)
入排标准
- 年龄范围
- 60 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Recorded as a current smoker during the year 2010 or in subsequent years since then.
排除标准
- •Active diagnosis of lung cancer or metastases
- •CT thorax within the past year
- •Inability to consent to study
- •Palliative care register
- •GPs alert to co-morbidity that contraindicates screening or treatment for lung cancer
结局指标
主要结局
Attendance to pre-allocated Lung Health Check Appointment
时间窗: At an expected average of 1 year from the start of the study.
Invitation to participation in the screening pilot will take place in blocks by GP practice and occur from day 1 until the end of recruitment (an estimated one year from the start of the study).
次要结局
- Proportion of those invited eligible for screening.(At an expected average of 1 year from the start of the study.)
- Smoking data of those attending.(At an expected average of 1 year from the start of the study.)
- Smoking data, data on lung cancer risk, symptom history and proportion of those attending that are eligible for screening.(At an expected average of 1 year from the start of the study.)
- Uptake of CT scans and willingness to be screening(At an expected average of 1 year from the start of the study.)
- Mortality(At an expected average of 2 years from the start of the study.)
- Adverse events(At an expected average of 2 years from the start of the study.)
- Demographics of all those invited.(At an expected average of 1 year from the start of the study.)
- Data on lung cancer risk of those attending.(At an expected average of 1 year from the start of the study.)
- Past medical and symptom history of those attending.(At an expected average of 1 year from the start of the study.)
- Informed decision making(At an expected average of 18 months from the start of the study.)
- Radiological and clinical outcomes of those screened(At an expected average of 2 years from the start of the study.)
- Numbers of investigations generated from screening(At an expected average of 2 years from the start of the study.)
- Psychological burden of screening(At an expected average of 18 months from the start of the study.)
- Costs generated from screening(At an expected average of 2 years from the start of the study.)