Impact on Quality of Life From Multi-modality Lung Cancer

Quality of Life Clinical Trial

— PIONEER  

Official title:

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04540757
• Other study ID #: CFTSp176
• Status: Recruiting
• Start date: November 25, 2020
• Est. completion date: January 31, 2023

Study information

• Verified date: February 2022
• Source: The Christie NHS Foundation Trust
• Contact: Sally Taylor, PhD
• Phone: 01619182446
• Email: sally.taylor38[@]nhs.net
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 66
• Est. completion date: January 31, 2023
• Est. primary completion date: August 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Lung Neoplasms
• Quality of Life

Intervention

Procedure:
• Surgery
Participants will be randomised to receive surgery as part of multi-modality treatment
• No surgery
Participants will be randomised to receive no surgery as part of multi-modality treatment

Locations

Country	Name	City	State
United Kingdom	Manchester University Foundation Trust- Wythenshawe	Manchester
United Kingdom	Salford Royal NHS Foundation Trust	Salford	Greater Manchester

Sponsors (2)

Lead Sponsor	Collaborator
The Christie NHS Foundation Trust	University of Manchester

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patients with N2 disease	Determine the proportion of patients with potentially resectable stage III N2 disease who are fit for surgery	20 months
Primary	Recruitment	Number of eligible patients recruited	20 months
Primary	Attrition	Number of patients lost to follow up	26 months
Primary	Treatment completion	The proportion of patients who complete their allocated treatment	6 months
Primary	Quality of life	Collected using the European Organisation for Research and Treatment of Cancer (EORTC QLQ-C30)	6 months
Primary	Quality of life	Collected using the European Organisation for Research and Treatment of Cancer (EORTC QLQ-C30-LC13)	6 months
Primary	Quality of life	Short Form 36 (SF36)	6 months
Primary	Anxiety and depression	Hospital Anxiety and Depression Scale (HADS)	6 months
Primary	EuroQOL 5D	Quality of life (EQ5D)	6 months
Primary	Service use/health economics	Study specific service use and health economics questionnaire	6 months
Primary	Mortality rates	Mortality rates collected by clinicians	6 months
Secondary	Patient experience	Interviews will be conducted with patients to explore their experiences in more detail.	26 months
Secondary	Carer quality of life	Carer Quality of life- cancer questionnaire	6 months
Secondary	Caregiver burden	Zarit Caregiver Burden	6 months
Secondary	Caregiver anxiety and depression	Hospital Anxiety and Depression Scale (HADS)	6 months