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临床试验/NCT04375566
NCT04375566Unknown不适用

Improving Decision Making by Developing and Testing a Progressive Web App About Patient Decision Aid for Stage I-II Non-small Cell Lung Cancer

Maastricht University1 个研究点 分布在 1 个国家目标入组 45 人开始时间: 2021年10月4日最近更新:
适应症

试验速览

阶段
不适用
入组人数
45
试验地点
1
主要终点
Usability of PDA

研究概览

简要总结

Studies indicate that the majority of early-stage non-small cell lung cancer (NSCLC) patients find it important to be involved in treatment decision making. However, in a recent study it has been reported that about 40% of the participants experienced decision conflict and feel uninformed(1). The investigators therefore developed a patient decision aid (PDA) for stage I-II NSCLC patients, that informs and empowers patients to help decide between stereotactic radiotherapy (SBRT) and surgery.

详细描述

A pilot study in which semi-structured interviews will be conducted (Qualitative research).In addition, patients will be asked to fill in a questionnaire about the usability of the prototype. A small group of patients (n=15) that have been treated for early stage NSCLC in the past will be asked to participate. The persons involved in this pilot are asked to assess a patient decision tool and will be interviewed only once. After the interview they will be asked to fill in a questionnaire. The burden of the pilot study is very low. No medical examinations or procedures will be carried out. Pilot study in lung cancer patients treated in the past with radiotherapy or surgery. The participants will all give informed consent. The investigators are using a qualitative design. Semi-structured interviews will be carried out. In addition the investigators will ask the participants to fill in a questionnaire with 35 questions.

No age limits are defined. The pilot study will be carried out in stage I-II NSCLC patients who were treated with radiotherapy or surgery, at least 6 months ago. Patients should currently be free of disease, no disease progression. The semi-structured interview consists of 17 open questions and text recorded, in order to be able to analyze the date afterwards. The interviews will take place when the patients come to the hospital for a regular follow-up appointment. After the interview, the patient is asked to fill in a questionnaire about the usability of the decision aid. In total, the expected duration is about 2 hours.

研究设计

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

入排标准

年龄范围
21 Years 至 100 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Early stage non-small cell lung patients, Treated with curative intent minimum 6 month ago, max 5 years. Doctors IT

排除标准

  • 未提供

结局指标

主要结局

Usability of PDA

时间窗: 1 year

Opinion of the respondents about patient decision aid

The accuracy of the information in the tool

时间窗: 1 year

Testing the information provided in the tool and the usability of the tool itself

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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