NCT04986189已完成不适用
Lung Screening for Hodgkin Lymphoma Survivors: a Feasibility Study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 102
- 试验地点
- 2
- 主要终点
- Primary outcome: the lung cancer screening uptake rate among eligible individuals invited to the study
研究概览
简要总结
A single site non-commercial study in which people treated for Hodgkin lymphoma survivors will be invited to have a single low dose CT of thorax for lung cancer screening
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Screening
- 盲法
- None
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
- •Aged 18-80
- •5 year or more survivor of HL
- •Any of: a) treated with radiotherapy for HL with radiation dose to the lung b) an alkylating agent containing chemotherapy regimen known to increase lung cancer risk
- •Living within approximately 40 miles of The Christie Hospital
排除标准
- •Previous diagnoses of malignant neoplasm of trachea, bronchus, lung, thymus or pleura
- •A current diagnosis of metastatic cancer
- •Residents in nursing homes or housebound
- •Had a CT scan of the thorax within the last 12 months
- •Pregnant women
- •Unable to provide consent
结局指标
主要结局
Primary outcome: the lung cancer screening uptake rate among eligible individuals invited to the study
时间窗: Measured 6 months after recruitment begins when all interested participants have undergone a full eligibility check and those eligible have undergone their baseline low dose CT scan
Feasibility outcome
次要结局
- Lung cancer screening knowledge pre and post receipt of the decision aid measured using a novel scale (score 0-16 with higher score representing high levels of knowledge about lung cancer screening)(4 months)
- Rates of normal, indeterminate and positive screening scans, reported according to definitions in the British Thoracic Society Pulmonary Nodule Management Guidelines(12 months)
- Cancer worry severity levels pre and post screening measured using measured using 4-item Brief Worry Scale (score 4-20 with higher score representing higher cancer worry severity levels)(12 months)
- Health related quality of life pre-screening then 6 and 12 months post screening measured using the validated SF-12 (short-form-12) scale (Scores range from 0 to 100, with higher scores indicating better physical and mental health functioning)(12 months)
- The acceptability of undergoing screening measured using non-validated scale (Score 7-70 with higher score representing higher perceived acceptability of lung cancer screening)(2 months)
- The type and prevalence of incidental findings on screening scans(12 months)
- The barriers and facilitators to undergoing lung cancer screening measured qualitatively and categorised according to the Theoretical Domains Framework(12 months)
- Preparedness for decision making in those who receive the decision aid using the validated Preparedness for Decision Making Scale (score 0-100 with higher score representing higher perceived levels of preparedness for decision making)(4 months)
- Decisional conflict scores in those who receive the decision aid measured using the validated Decisional Conflict Scale (score 0-100 with higher score representing higher levels of decisional conflict)(14 months)
- The proportion who have made an informed decision as measured by the Multidimensional Measure of Informed Choice(6 and 12 months following CT scan)
- The rates of smoking cessation 6 and 12 months following screening(12 months)
- Anxiety levels pre and post screening measured using the State Trait Anxiety Inventory -6 validated scale (score 6-24 with higher score representing higher levels of anxiety)(2 months post CT scan)
- Cancer worry frequency measured using intrusive thoughts subscale from Revised impact of events scale (score 6-30 with higher score representing more frequent cancer worry)(12 months)
研究者
研究点 (2)
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