Curative Treatment Modalities of Early Stages Non-Small Cell Lung Cancer: Effect on Patient Reported Outcomes of Video Assisted Thoracoscopic (VATS) Resection and Stereotactic Ablative Body Radiotherapy (SABR)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 244
- 主要终点
- Patients Reported Outcomes
研究概览
简要总结
This study will monitor the effect on patients reported outcomes (PROMs) of VATS resection and SABR for NSCLC delivered at the Leeds Cancer Centre The investigator will support with this information the Shared Decision Making (SDM) process.
300 consecutive patients will be followed up from prior the treatment to 12 months afterwards, administering multiple questionnaires (EORTC QLQ C-30 and LC-13, PSQ-18, Decision Self-Efficacy Scale) by a remote web-based system.
Deliverable:
- Differences after VATS resections or SABR in terms of physical and psychological symptoms, quality of life and satisfaction
- Patient perspectives of the Shared Decision Making Process.
详细描述
- Methods
Aim and Objectives
This study aims to describe the trajectory of lung cancer patients HRQoL, symptoms and functions following VATS or SABR treatment for Stage I-II NSCLC and to determine the feasibility and patient acceptability of online self-reporting of PROMs.
Specific objectives of the study include:
- To compare changes before and after treatment of patient reported outcomes (HRQOL and Patient Satisfaction) after VATS lung resections or SABR in early stage lung cancer patients.
- To correlate clinical outcomes (complications and AEs) with Quality of Life in order to find objective predictors of major decline in patient reported outcomes.
- To identify specific factors, which have influenced the personal choice between the treatments (Decision Self-Efficacy Scale)
- Establish recruitment and attrition rates and adherence to PROMs reporting during the study
- To describe patient choice of electronic vs paper questionnaires
- To explore implementation issues through patient and staff interview.
- Design
This is an observational prospective longitudinal study with repeated measures (PROMs), employing a convenience sample of consecutive patients planned to have VATS resections or SABR for stages I-II of NSCLC. Outcomes measures will be collected prior to treatment and 1,3,6,12 months afterwards, administering the questionnaires by the remote web-based system. Paper administration will be offered to patients without Internet access.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 years and over.
- •Diagnosis of NSCLC either from histology or MDT/Tumour Board agreement on >95% likelihood of diagnosis based on radiological evidence or both.
- •Decision for either surgery or SABR
- •Able to give informed consent.
- •Able to understand the language of the questionnaire.
- •There will be no limit on performance status.
排除标准
- •Advanced diseases (III-IV stages).
- •Patient included in other HRQoL study, which may increase patient burden and bias the answer of the questionnaires.
结局指标
主要结局
Patients Reported Outcomes
时间窗: 12 months
Quality of life (EORTC QLQ-C30 and LC13 questionnaire)
次要结局
- Patient Acceptability(12 months)
- Decision self-efficacy scale(3 months)
- Patients satisfaction(1 month)
- Clinician Acceptability(12 months)
研究者
Galina Velikova
Prof of Clinical Oncology
University of Leeds