Skip to main content
OpenTrials
Completed

NCT Number: NCT05359718

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Solid Tumor

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

The Christie NHS Foundation Trust

Manchester, Greater Manchester, M20 4BX, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Patients who lack capacity to participate.

Treatment and study plan

Questionnaire

Other

Questionnaire

Primary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  1. To determine the factors contributing to anxiety, depression and post-traumatic stress during COVID-19 determined by the above questionnaires

    Time frame: 12 months

    GAD-7

  2. To determine the factors contributing to anxiety, depression and post-traumatic stress during COVID-19 determined by the above questionnaires

    Time frame: 12 months

    PHQ-9

  3. To determine the factors contributing to anxiety, depression and post-traumatic stress during COVID-19 determined by the above questionnaires

    Time frame: 12 months

    PC-PTSD-5

  4. 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

    Time frame: 12 months

    By assessing WHO-5

  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

    Time frame: 12 months

    By assessing thermometer questionnaires.

  6. To correlate the novel well-being thermometer with existing psychometric scales as a screening tool for future patient assessment.

    Time frame: 12 months

    Correlating the Well-being thermometer with the above psychometric measures.

Sponsors and collaborators

Lead sponsor

The Christie NHS Foundation Trust

Other

Registry information

Acronym: PICO SM

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
May 4, 2022
Registry last updated
Nov 14, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.