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临床试验/NCT04986189
NCT04986189已完成不适用

Lung Screening for Hodgkin Lymphoma Survivors: a Feasibility Study

The Christie NHS Foundation Trust2 个研究点 分布在 1 个国家目标入组 102 人开始时间: 2021年8月1日最近更新:
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

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

申办方类型
Other
责任方
Sponsor

研究点 (2)

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