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临床试验/NCT04813068
NCT04813068Unknown不适用

A Qualitative Study of Patients' Attitudes to the Risks and Potential Benefits of Potential Toxicities of Radical Re-irradiation for Lung Cancer

NHS Greater Glasgow and Clyde1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2021年4月16日最近更新:
适应症

试验速览

阶段
不适用
入组人数
30
试验地点
1
主要终点
Feelings and concerns re: second radiotherapy course

研究概览

简要总结

Patients with lung cancer are often treated with high dose x-ray treatment (radical radiotherapy) to control the disease. After one course of radiotherapy, after a period of time, there is a risk that the cancer can come back in either the same place or nearby in the lungs. This happens to about 700 patients in the UK every year. There is no strong evidence to suggest what the best treatment is in this situation.

One possible treatment is a second course of radiotherapy (re-irradiation). Early studies show that a re-irradiation may cause significant side effects like breathlessness or problems swallowing, but may control the cancer for a long period of time. We want to do a clinical trial to investigate if re-irradiation improves cancer control compared to other treatments to help guide treatment for patients with recurrent disease.

Before we can go ahead with the trial, we would like to talk to patients who are have completed radiotherapy to find out what are their feelings about having a second course of radiotherapy if needed, and how the side effects from the initial course of radiotherapy or the projected side-effects from the second course would affect that decision.

This information is vitally important to help develop a trial about re-irradiation in lung cancer as it will demonstrate if patients would accept a second course of radiotherapy, and, by accounting for patient concerns in the trial design, will make it more likely to recruit well.

This study will perform telephone interviews with patients five weeks after completing a course of radical radiotherapy for lung cancer at the Beatson Cancer Centre. We expect to interview 16-30 patients. This study will run over the course of 1 year. This research is funded by the Beatson Cancer Charity and The University of Glasgow.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age 18 years old or above
  • Pathological or radiological diagnosis of non-small cell lung cancer
  • Undergoing radical radiotherapy to the thorax using the following fractionations (55 Gray in 20 fractions, 54 Gray in 36 fractions or any Stereotactic Ablative Body Radiotherapy (SABR) fractionation that delivers a biological effective dose of greater than 100Gy10) as part of their primary lung cancer treatment at time of study enrolment
  • Patients receiving concurrent and/or adjuvant systemic therapies are permitted
  • Radiotherapy is delivered in the Beatson West of Scotland Cancer Centre
  • Signed, written informed consent
  • Willing and able to complete study processes

排除标准

  • Not fluent in English

结局指标

主要结局

Feelings and concerns re: second radiotherapy course

时间窗: Dec 2021

Explore patients' feelings and concerns about having a second course of radiotherapy for recurrent lung cancer. This will be assessed using thematic analysis of the transcripts of semi-structured interviews, and the outcome will be the identification of themes that participants have expressed with regard to a second course of radiotherapy e.g. "side-effects of radiotherapy", or "cost of another treatment".

次要结局

  • Choice of treatment in recurrent setting(Dec 2021)
  • Attitude to side effects in context of possible outcomes(Dec 2021)
  • Toxicity from previous radiotherapy(Dec 2021)
  • Attitude to surveillance scans(Dec 2021)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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