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

Solid Tumor Clinical Trial

— PICO SM  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05359718
• Other study ID #: CFTSp196
• Status: Completed
• Start date: March 1, 2021
• Est. completion date: September 13, 2023

Study information

• Verified date: February 2024
• Source: The Christie NHS Foundation Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 312
• Est. completion date: September 13, 2023
• Est. primary completion date: September 13, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Neoplasms
• Solid Tumor

Intervention

Other:
• Questionnaire
Questionnaire

Locations

Country	Name	City	State
United Kingdom	The Christie NHS Foundation Trust	Manchester	Greater Manchester

Sponsors (1)

Lead Sponsor	Collaborator
The Christie NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	To determine the factors contributing to anxiety, depression and post-traumatic stress during COVID-19 determined by the above questionnaires	GAD-7	12 months
Secondary	To determine the factors contributing to anxiety, depression and post-traumatic stress during COVID-19 determined by the above questionnaires	PHQ-9	12 months
Secondary	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
Secondary	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
Secondary	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
Secondary	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