The Psychological Impact of COVID-19 on Patients with Solid Malignancies: a Single-Institution Survey Study

Completed

• Conditions: Solid Tumor

• Registration Number: NCT05359718
• Lead Sponsor: The Christie NHS Foundation Trust

Brief Summary

The COVID-19 pandemic and the subsequent government-imposed restrictions have undeniably resulted in unprecedented changes to the life of patients with cancer. It has become more evident that patients with cancer may be at significant risk of higher morbidity and mortality when infected with SARS-CoV-2, which is understandably causing anxiety amongst both patients and their oncology team.

This project is a single centre, non-interventional observational prospective cohort study; which aims to evaluate the impact of COVID-19 on the mental health and general wellbeing of patients diagnosed with solid malignancies by utilising a range of non-invasive questionnaires (GAD-7, PHQ-9, PC-PTSD-5, WHO-5 and Wellbeing thermometer). Data on patient demographics, treatment and medical history, and medical resource utilization will be obtained through a medical chart review at enrolment for up to 4 months. Participants will be asked to complete five questionnaires regarding their mental health and wellbeing status during their routine clinic visits, but no other additional tests or procedures will be undertaken for the study outside of their routine care.

It is essential to understand both the short and long term psychological consequences of COVID-19 on cancer patients to better inform the institute and other regional and national stakeholders of the scale of the issue, in order to recommend necessary measures and resources required to address this important issue.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-03-01
• Study First Submitted: 2021-03-08
• Study First Submitted QC: 2022-05-03
• Study First Posted: 2022-05-04
• Primary Completion: 2023-09-13
• Study Completion: 2023-09-13
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-12
• Last Update Posted: 2024-11-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 312

Inclusion Criteria

1. Age 18 or over.
2. Cancer diagnosis
3. Able to fully comprehend the Patient Information Sheet

Exclusion Criteria

1. Patients who lack capacity to participate.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To evaluate the levels of anxiety, depression, post-traumatic stress and well-being amongst patients with cancer during the COVID-19 pandemic using PHQ-9 (Patient Health Questionnaire-9)	12 months	Psychometric Measure, higher score indicates greater depression
To evaluate the levels of anxiety, depression, post-traumatic stress and well-being amongst patients with cancer during the COVID-19 pandemic using World Health Organisation Five-Wellbeing Index	12 months	Psychometric Measure, assesses general psychological wellbeing
To evaluate the levels of anxiety, depression, post-traumatic stress and well-being amongst patients with cancer during the COVID-19 pandemic using Generalised Anxiety Disorder Assessment (GAD-7)	12 months	Psychometric Measure - higher scores indicates greater anxiety
To evaluate the levels of anxiety, depression, post-traumatic stress and well-being amongst patients with cancer during the COVID-19 pandemic using The Primary Care Post-Traumatic Stress Disorder (PC-PTSD-5)	12 months	Psychometric Measure, higher scores indicates greater risk of Post-Traumatic Stress Disorder
To evaluate the levels of anxiety, depression, post-traumatic stress and well-being amongst patients with cancer during the COVID-19 pandemic using Well-being thermometer	12 months	Psychometric Measure

Secondary Outcome Measures

Name	Time	Method
To correlate the novel well-being thermometer with existing psychometric scales as a screening tool for future patient assessment.	12 months	Correlating the Well-being thermometer with the above psychometric measures.
To determine the factors contributing to anxiety, depression and post-traumatic stress during COVID-19 determined by the above questionnaires	12 months	PC-PTSD-5
To understand the needs of cancer patients during the period of a pandemic in order to help further develop immediate and longer term support measures	12 months	By assessing thermometer questionnaires.

Trial Locations

Locations (1)

The Christie NHS Foundation Trust; 🇬🇧 Manchester, Greater Manchester, United Kingdom