Impact of COVID-19 on Lung Cancer Patients

NCT ID: NCT04538456

Last Updated: 2024-04-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

296 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-10-15

Study Completion Date

2022-04-16

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Lung Cancer PROM Covid19 Psychological

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

questionnaire and optional interview

Intervention Type OTHER

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.

questionnaire and optional interview

Intervention Type OTHER

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

The Christie NHS Foundation Trust

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

The Christie NHS Foundation

Manchester, , United Kingdom

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United Kingdom

Related Links

Access external resources that provide additional context or updates about the study.

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

CFTSp189

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

COVID-19 and Cancer Patients
NCT04393974 COMPLETED
Cognition and Patients With Lung Cancer
NCT07160751 NOT_YET_RECRUITING
Survival Outcomes of Lung Cancer
NCT03647098 RECRUITING