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Clinical Trials/NCT05359718
NCT05359718
Completed
N/A

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

The Christie NHS Foundation Trust1 site in 1 country312 target enrollmentMarch 1, 2021
ConditionsSolid Tumor

Overview

Phase
N/A
Intervention
Not specified
Conditions
Solid Tumor
Sponsor
The Christie NHS Foundation Trust
Enrollment
312
Locations
1
Primary Endpoint
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)
Status
Completed
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
March 1, 2021
End Date
September 13, 2023
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Age 18 or over.
  • Cancer diagnosis
  • Able to fully comprehend the Patient Information Sheet

Exclusion Criteria

  • Patients who lack capacity to participate.

Outcomes

Primary Outcomes

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)

Time Frame: 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

Time Frame: 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)

Time Frame: 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)

Time Frame: 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

Time Frame: 12 months

Psychometric Measure

Secondary Outcomes

  • To correlate the novel well-being thermometer with existing psychometric scales as a screening tool for future patient assessment.(12 months)
  • To determine the factors contributing to anxiety, depression and post-traumatic stress during COVID-19 determined by the above questionnaires(12 months)
  • 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)

Study Sites (1)

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