Impact on Quality of Life From Multi-modality Lung Cancer (PIONEER)

The Christie NHS Foundation Trust

Status: Unknown

Conditions: Lung Neoplasms; Quality of Life

Treatments: Procedure: No surgery; Procedure: Surgery

Study type: Observational

Funder types: Other

Identifiers

NCT04540757

CFTSp176

Details and patient eligibility

About

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:

1. surgery PLUS chemo radiotherapy or chemotherapy
2. 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.

Full description

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:

1. surgery PLUS chemo radiotherapy or chemotherapy

2. 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.

Enrollment: 66 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• Patients unable to provide informed consent
• Patients who are not able to read and understand English

Trial design

66 participants in 2 patient groups

Surgery

Description:

Surgery and systemic anti-cancer therapy (with or without radiotherapy) given in any order

Treatment:

Procedure: Surgery

No surgery

Description:

Radiotherapy and systemic anti-cancer treatment given in any order (with or without adjuvant immunotherapy if indicated).

Treatment:

Procedure: No surgery