跳至主要内容
临床试验/NCT04538456
NCT04538456已完成不适用

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

The Christie NHS Foundation Trust1 个研究点 分布在 1 个国家目标入组 296 人开始时间: 2020年10月15日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
296
试验地点
1
主要终点
Physical and Social impact

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • 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

结局指标

主要结局

Physical and Social impact

时间窗: baseline

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.

Psychological impact

时间窗: baseline

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.

次要结局

  • prevalence and impact of frailty(baseline)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验