Viewing Study NCT04538456



Ignite Creation Date: 2024-05-06 @ 3:08 PM
Last Modification Date: 2024-10-26 @ 1:44 PM
Study NCT ID: NCT04538456
Status: COMPLETED
Last Update Posted: 2024-04-24
First Post: 2020-09-01

Brief Title: Impact of COVID-19 on Lung Cancer Patients
Sponsor: The Christie NHS Foundation Trust
Organization: The Christie NHS Foundation Trust

Study Overview

Official Title: Understanding the Physical Social and Psychological Impact of COVID-19 on Frail and Shielded Lung Cancer Patients
Status: COMPLETED
Status Verified Date: 2024-04
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: During the COVID-19 pandemic peoples 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
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 48000 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 EnglandPHE 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 patients 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 himher 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 Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None