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

• Sponsor: The Christie NHS Foundation Trust (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04540757
• Collaborator: University of Manchester (Other)
• Enrollment: 66
• Locations: 2
• Anticipated Duration (Months): 26.2
• Patients Per Site: 33
• Patients Per Site Per Month: 1.3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Lung Neoplasms; Quality of Life	Procedure: Surgery; Procedure: No surgery

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 Design

• Study Type: Observational
• Anticipated Enrollment: 66 participants
• Observational Model: Other
• Time Perspective: Prospective
• 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)
• Actual Study Start Date: Nov 25, 2020
• Anticipated Primary Completion Date: Aug 31, 2022
• Anticipated Study Completion Date: Jan 31, 2023

Arms and Interventions

Arm	Intervention/Treatment
Surgery Surgery and systemic anti-cancer therapy (with or without radiotherapy) given in any order	Procedure: Surgery; 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).	Procedure: No surgery; Participants will be randomised to receive no surgery as part of multi-modality treatment

Outcome Measures

Primary Outcome Measures

1. Patients with N2 disease [20 months]

   Determine the proportion of patients with potentially resectable stage III N2 disease who are fit for surgery

2. Recruitment [20 months]

   Number of eligible patients recruited

3. Attrition [26 months]

   Number of patients lost to follow up

4. Treatment completion [6 months]

   The proportion of patients who complete their allocated treatment

5. Quality of life [6 months]

   Collected using the European Organisation for Research and Treatment of Cancer (EORTC QLQ-C30)

6. Quality of life [6 months]

   Collected using the European Organisation for Research and Treatment of Cancer (EORTC QLQ-C30-LC13)

7. Quality of life [6 months]

   Short Form 36 (SF36)

8. Anxiety and depression [6 months]

   Hospital Anxiety and Depression Scale (HADS)

9. EuroQOL 5D [6 months]

   Quality of life (EQ5D)

10. Service use/health economics [6 months]

    Study specific service use and health economics questionnaire

11. Mortality rates [6 months]

    Mortality rates collected by clinicians

Secondary Outcome Measures

1. Patient experience [26 months]

   Interviews will be conducted with patients to explore their experiences in more detail.

2. Carer quality of life [6 months]

   Carer Quality of life- cancer questionnaire

3. Caregiver burden [6 months]

   Zarit Caregiver Burden

4. Caregiver anxiety and depression [6 months]

   Hospital Anxiety and Depression Scale (HADS)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Salford Royal NHS Foundation Trust	Salford	Greater Manchester	United Kingdom	M68HD
2	Manchester University Foundation Trust- Wythenshawe	Manchester		United Kingdom	M139WL

Sponsors and Collaborators

• The Christie NHS Foundation Trust
• University of Manchester

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: The Christie NHS Foundation Trust
• ClinicalTrials.gov Identifier: NCT04540757
• Other Study ID Numbers: CFTSp176
• First Posted: Sep 7, 2020
• Last Update Posted: Feb 3, 2022
• Last Verified: Feb 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by The Christie NHS Foundation Trust: non small cell lung cancer; Stage III N2; Quality of life; Multi-modality treatment
• Additional relevant MeSH terms: Lung Neoplasms

Study Results

No Results Posted as of Feb 3, 2022