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

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.

Study Overview

• Status: Completed
• Conditions: Solid Tumor
• Intervention / Treatment: Other: Questionnaire

• Study Type: Observational
• Enrollment (Actual): 312

Contacts and Locations

• Study Contact: Name: Mark Cutting; Phone Number: 44 (0)161 446 8562; Email: mark.cutting1@nhs.net

Study Locations

• United Kingdom
  • Greater Manchester
    • Manchester, Greater Manchester, United Kingdom, M20 4BX
      • The Christie NHS Foundation Trust

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Secondary care

Description

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 Plan

How is the study designed?

What is the study measuring?

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 Well-being thermometer	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 Generalised Anxiety Disorder Assessment (GAD-7)	Psychometric Measure - higher scores indicates greater anxiety	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 (Patient Health Questionnaire-9)	Psychometric Measure, higher score indicates greater depression	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 The Primary Care Post-Traumatic Stress Disorder (PC-PTSD-5)	Psychometric Measure, higher scores indicates greater risk of Post-Traumatic Stress Disorder	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 World Health Organisation Five-Wellbeing Index	Psychometric Measure, assesses general psychological wellbeing	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

Collaborators and Investigators

• Sponsor: The Christie NHS Foundation Trust

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2021
• Primary Completion (Actual): September 13, 2023
• Study Completion (Actual): September 13, 2023

Study Registration Dates

• First Submitted: March 8, 2021
• First Submitted That Met QC Criteria: May 3, 2022
• First Posted (Actual): May 4, 2022

Study Record Updates

• Last Update Posted (Actual): February 8, 2024
• Last Update Submitted That Met QC Criteria: February 6, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: CFTSp196

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No