Impact of COVID-19 on Lung Cancer Patients

Understanding the Physical, Social and Psychological Impact of COVID-19 on Frail and Shielded Lung Cancer Patients

During the COVID-19 pandemic, people's lives have changed dramatically. People with lung cancer who are shielding may have been particularly affected as they may be unable to carry out many of their normal daily activities, such as grocery shopping and exercise, and are unable to interact with friends and family. People with lung cancer will also have experienced some changes to the clinical services available to them at The Christie. Using a questionnaire and interviews, the investigators want to understand patient experiences of the changes in their daily lives and the changes to their clinical care. This will help us to see if people with lung cancer need any additional support services or if there are any changes the investigators can make to clinical services to improve patient experiences. Eligible patients will be any lung cancer patients receiving current treatment or in active follow up.

Study Overview

• Status: Completed
• Conditions: Covid19; Lung Cancer; Psychological; PROM
• Intervention / Treatment: Other: questionnaire and optional interview

Detailed Description

The COVID-19 pandemic, declared by the World Health Organisation (WHO) on 11 March 2020, has managed to dramatically change all of our lives in just a few short months. Due to the unprecedented demand to protect the National Health service (NHS), on 23 March 2020 the United Kingdom (UK) government initiated a lock down, imposing wide-ranging restrictions on freedom of movement. Cancer services have been being particularly impacted across the country.

Around 48,000 patients are newly diagnosed with lung cancer in the UK each year. Those who require active treatment may be offered radiotherapy, systemic anticancer therapy including chemotherapy, targeted therapy or immunotherapy, or a combination of both. A recent document published by Public Health England(PHE) has classified lung cancer patients receiving any of these treatments as 'extremely vulnerable.' Common co-existing comorbidities such as Chronic Obstructive Pulmonary Disease (COPD) also place patients into this category. Their vulnerability may be further amplified when considering that 44% of all new lung cancer diagnoses are in people aged >75 years and a significant proportion is particularly frail. The advice from PHE for these 'extremely vulnerable' patients was to shield, meaning they should not leave their homes or attend any social gatherings, even with family or friends. Shielding unfortunately is not without its own challenges. It may prevent many patients from carrying out their daily life activities independently, limit their ability to exercise and impact their mental further. This is particularly relevant for those patients more vulnerable or frail. It would therefore be expected that these patients are likely to develop some degree of psychological distress. The act of shielding itself may be implicated in this owing to increased social isolation, upset to normal routines and general anxiety regarding COVID-19 related or other issues. In addition any change to routine lung cancer management in these patients may exacerbate this distress further. Those with underlying mental health issues are at particular risk.

During the COVID-19 pandemic both the lung cancer diagnosis and its subsequent management have been affected. These rapid changes reflected the shifting risk-benefit ratio for patients and diminished resources. Beyond modifications in treatment pathways, telephone consultations have replaced many face to face appointments in an attempt to reduce visits to hospital. The use of electronic Health tools and telemedicine has therefore suddenly come to the fore front of clinical practice.

At the Christie NHS Foundation Trust, all lung cancer patients have been given the opportunity to regularly complete electronic patient reported outcome measures routinely as part of their clinical care since December 2018. Patients are sent a text message either on the day of a new patient appointment or three days before a follow-up appointment. They are asked to complete the electronic Patient Reported Outcome Measures specifically selected for each patient's diagnosis and treatment pathway including a list of symptoms based on the Common Terminology Criteria for Adverse Events. The EuroQual-5D quality of life questionnaire is also included. This allows clinicians to review patients' symptoms before the consultation, allowing him/her to focus on the concerning symptoms and quality of life issues. Moreover, all new lung cancer patients are also screened for frailty within the Frailty Project through the electronic use of Rockwood Clinical Frailty Scale which is performed by clinicians.

• Study Type: Observational
• Enrollment (Actual): 296

Contacts and Locations

Study Locations

• United Kingdom
  • Manchester, United Kingdom, M20 4BX
    • The Christie NHS Foundation

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Additionally, participants will need to meet the criteria to be selected for one of the two cohorts of patients:

1. Lung cancer patients voluntarily using the ePROMs platform with at least 1 assessment completed in the 6 months prior to 23 March 2020 (COVID-19 lockdown date) and 1 assessment after this date or new patients who have completed their first electronic Patient Reported Outcome Measures after 23 March 2020
2. Lung cancer patients who have never complete electronic Patient Reported Outcome Measures data.

Description

Inclusion Criteria:

• non-small cell lung cancer (NSCLC) or small cell lung cancer (SCLC)
• patients in active treatment or in clinical follow-up

Exclusion Criteria:

• Lung cancer patients who do not speak or understand English will not be eligible to take part in the study
• Patients under the age of 18 will be eligible for the study

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
used electronic Patient Reported Outcome Measures; Lung cancer patients who have used the electronic Patient Reported Outcome Measures system before and after COVID-19 lock down or new patients who have completed their first electronic Patient Reported Outcome Measures after COVID-19 lock down.	Other: questionnaire and optional interview; Participants will be sent an online or paper questionnaire. If participants have expressed an interest in taking part in an interview, they may be contacted by a member of the research team. The interviews will be conducted over the phone at time suitable for the participant. There will be no study specific hospital visits.
never used electronic Patient Reported Outcome Measures; Lung cancer patients who have never completed electronic Patient Reported Outcome Measures.	Other: questionnaire and optional interview; Participants will be sent an online or paper questionnaire. If participants have expressed an interest in taking part in an interview, they may be contacted by a member of the research team. The interviews will be conducted over the phone at time suitable for the participant. There will be no study specific hospital visits.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Physical and Social impact	Physical and social impact will be captured by the EuroQual-5D quality of life and questions regarding patient's diagnosis and treatment pathway including a list of symptoms based on the Common Terminology Criteria for Adverse Events.	baseline
Psychological impact	Emotional impact will be assessed using the Hospital Anxiety Depression Scale. Scores range from 0-21 for each of the two subscales (anxiety and depression), with higher scores indicating greater anxiety and depression.	baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
prevalence and impact of frailty	Frailty will be assessed using the Rockwood Clinical Frailty Scale. With scores ranging from 1-9, with higher scores indicating higher frailty.	baseline

Collaborators and Investigators

• Sponsor: The Christie NHS Foundation Trust

Publications and helpful links

Helpful Links

• Link to third publication
• Link to second publication
• Link to HRA summary of results

Study record dates

Study Major Dates

• Study Start (Actual): October 15, 2020
• Primary Completion (Actual): April 16, 2022
• Study Completion (Actual): April 16, 2022

Study Registration Dates

• First Submitted: September 1, 2020
• First Submitted That Met QC Criteria: September 3, 2020
• First Posted (Actual): September 4, 2020

Study Record Updates

• Last Update Posted (Actual): April 24, 2024
• Last Update Submitted That Met QC Criteria: April 23, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Neoplasms; Pneumonia, Viral; Pneumonia; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; COVID-19; Lung Neoplasms
• Other Study ID Numbers: CFTSp189

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No