Impact on Quality of Life From Multi-modality Lung Cancer

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

66 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-11-25

Study Completion Date

2023-01-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Lung Neoplasms Quality of Life

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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Surgery

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

Surgery

Intervention Type PROCEDURE

Participants will be randomised to receive surgery as part of multi-modality treatment

No surgery

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

No surgery

Intervention Type PROCEDURE

Participants will be randomised to receive no surgery as part of multi-modality treatment

Interventions

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Surgery

Participants will be randomised to receive surgery as part of multi-modality treatment

Intervention Type PROCEDURE

No surgery

Participants will be randomised to receive no surgery as part of multi-modality treatment

Intervention Type PROCEDURE

Eligibility Criteria

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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