ImPact on QualIty Of Life From Multi-modality Treatment for Lung caNcEr: A Randomised Controlled fEasibility tRial of Surgery Versus no Surgery as Part of Multi-modality Treatment in Potentially Resectable Stage III-N2 NSCLC (The PIONEER Trial)
试验速览
- 阶段
- 不适用
- 入组人数
- 66
- 试验地点
- 2
- 主要终点
- Attrition
研究概览
简要总结
The investigators aim to explore how lung cancer patients and their family carers are affected by different types of cancer treatment. The investigators are focusing on a particular type of lung cancer called Stage III N2. N2 means the cancer has spread just outside the lung to the lymph nodes. There are two main treatments available in the UK for this type of lung cancer:
- surgery PLUS chemo radiotherapy or chemotherapy
- radiotherapy PLUS chemotherapy Patients live for a similar length of time with either treatment option so it is difficult for patients and health professionals to know which treatment to choose. It is important to understand the impact of the treatment on patients in their daily lives. Patients will be allocated at random to receive one of the two treatments options. Patients and carers will complete questionnaires and take part in interviews. The results of this study will help the investigators decide if a larger study should be conducted in the future.
详细描述
The investigators aim to explore how lung cancer patients and their family carers are affected by different types of cancer treatment.The information collected will help patients and their carers in the future to make decisions about the best treatment option for them. The investigators are focusing on a particular type of lung cancer called Stage III N2. N2 means the cancer has spread just outside the lung to the lymph nodes. Around 2500 patients a year in the UK are diagnosed with this type of lung cancer. There are two main treatments available in the UK:
- surgery PLUS chemo radiotherapy or chemotherapy
- radiotherapy PLUS chemotherapy Patients live for a similar length of time with either treatment option so it is difficult for patients and health professionals to know which treatment to choose. Research has not explored how the two different treatments offered affect individual patients and their carer. It is important to understand the impact of the treatment on:
- Symptoms
- Side effects
- Emotional well-being
- Day to day activities
Other research studies including N2 lung cancer patients have struggled with patient recruitment. This study design will show us if it is possible to run this type of research with this group of patients. Patients will be allocated at random to receive one of the two treatments options: 1) surgery PLUS chemo radiotherapy or chemotherapy 2) radiotherapy PLUS chemotherapy Patients and carers will complete questionnaires and take part in interviews. Health professionals will also be asked to take part in interviews. These interviews will help the investigators to understand their experience of recruiting patients to this study. The results of this study will help the investigators decide if a larger study should be conducted in the future.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 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
- •Patients with potentially resectable T1-4 N2 M0 NSCLC who have received an multi disciplinary team recommendation for multi-modality treatment
- •Multi disciplinary team consensus that the patient has adequate physiological reserve for multi-modality treatment and either treatment arm is both technically and clinically appropriate
- •Patient over the age of 18 years
- •Carer criteria:
- •Carers of patients who have consented to take part in the randomised controlled trial
- •Over the age of 18 years
排除标准
- •Patients unable to provide informed consent
- •Patients who are not able to read and understand English
结局指标
主要结局
Attrition
时间窗: 26 months
Number of patients lost to follow up
Quality of life
时间窗: 6 months
Short Form 36 (SF36)
Anxiety and depression
时间窗: 6 months
Hospital Anxiety and Depression Scale (HADS)
Treatment completion
时间窗: 6 months
The proportion of patients who complete their allocated treatment
Patients with N2 disease
时间窗: 20 months
Determine the proportion of patients with potentially resectable stage III N2 disease who are fit for surgery
Recruitment
时间窗: 20 months
Number of eligible patients recruited
Mortality rates
时间窗: 6 months
Mortality rates collected by clinicians
EuroQOL 5D
时间窗: 6 months
Quality of life (EQ5D)
Service use/health economics
时间窗: 6 months
Study specific service use and health economics questionnaire
次要结局
- Patient experience(26 months)
- Caregiver anxiety and depression(6 months)
- Carer quality of life(6 months)
- Caregiver burden(6 months)