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

Study Overview
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Brief Summary
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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.

Official Title
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The Psychological Impact of COVID-19 on Patients With Solid Malignancies: A Single-Institution Survey Study

Conditions
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Solid Tumor

Intervention / Treatment
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* Other: Questionnaire


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18 or over. Cancer diagnosis Able to fully comprehend the Patient Information Sheet Exclusion Criteria: 1. Patients who lack capacity to participate.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Questionnaire|Questionnaire|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the levels of anxiety, depression, post-traumatic stress and well-being amongst patients with cancer during the COVID-19 pandemic using GAD-7 | Psychometric Measure | 12 months | 
| 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 | Psychometric Measure | 12 months | 
| To evaluate the levels of anxiety, depression, post-traumatic stress and well-being amongst patients with cancer during the COVID-19 pandemic using PC-PTSD-5 | Psychometric Measure | 12 months | 
| To evaluate the levels of anxiety, depression, post-traumatic stress and well-being amongst patients with cancer during the COVID-19 pandemic using WHO-5 | Psychometric Measure | 12 months | 
| 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 | Psychometric Measure | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine the factors contributing to anxiety, depression and post-traumatic stress during COVID-19 determined by the above questionnaires | GAD-7 | 12 months | 
| To determine the factors contributing to anxiety, depression and post-traumatic stress during COVID-19 determined by the above questionnaires | PHQ-9 | 12 months | 
| To determine the factors contributing to anxiety, depression and post-traumatic stress during COVID-19 determined by the above questionnaires | PC-PTSD-5 | 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 | By assessing WHO-5 | 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 | By assessing thermometer questionnaires. | 12 months | 
| To correlate the novel well-being thermometer with existing psychometric scales as a screening tool for future patient assessment. | Correlating the Well-being thermometer with the above psychometric measures. | 12 months |