Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04538456 |
| Other study ID # |
CFTSp189 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
October 15, 2020 |
| Est. completion date |
April 16, 2022 |
Study information
| Verified date |
April 2024 |
| Source |
The Christie NHS Foundation Trust |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
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.
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.
