Impact on Quality of Life From Multi-modality Lung Cancer

• Conditions: Lung Neoplasms; Quality of Life
• Interventions: Procedure: Surgery; Procedure: No surgery

• Registration Number: NCT04540757
• Lead Sponsor: The Christie NHS Foundation Trust

Brief Summary

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.

Detailed 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.

Study Timeline

• Study First Submitted: 2020-04-06
• Study First Submitted QC: 2020-09-03
• Study First Posted: 2020-09-07
• Study Start: 2020-11-25
• Status Verified: 2022-02
• Last Update Submitted: 2022-02-02
• Last Update Posted: 2022-02-03
• Primary Completion: 2022-08-31
• Study Completion: 2023-01-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 66

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Surgery	Surgery	Surgery and systemic anti-cancer therapy (with or without radiotherapy) given in any order
No surgery	No surgery	Radiotherapy and systemic anti-cancer treatment given in any order (with or without adjuvant immunotherapy if indicated).

Primary Outcome Measures

Name	Time	Method
Quality of life	6 months	Short Form 36 (SF36)
Anxiety and depression	6 months	Hospital Anxiety and Depression Scale (HADS)
Service use/health economics	6 months	Study specific service use and health economics questionnaire
Attrition	26 months	Number of patients lost to follow up
Treatment completion	6 months	The proportion of patients who complete their allocated treatment
Patients with N2 disease	20 months	Determine the proportion of patients with potentially resectable stage III N2 disease who are fit for surgery
Recruitment	20 months	Number of eligible patients recruited
Mortality rates	6 months	Mortality rates collected by clinicians
EuroQOL 5D	6 months	Quality of life (EQ5D)

Secondary Outcome Measures

Name	Time	Method
Caregiver burden	6 months	Zarit Caregiver Burden
Patient experience	26 months	Interviews will be conducted with patients to explore their experiences in more detail.
Carer quality of life	6 months	Carer Quality of life- cancer questionnaire
Caregiver anxiety and depression	6 months	Hospital Anxiety and Depression Scale (HADS)

Trial Locations

Locations (2)

Manchester University Foundation Trust- Wythenshawe; 🇬🇧 Manchester, United Kingdom

Salford Royal NHS Foundation Trust; 🇬🇧 Salford, Greater Manchester, United Kingdom