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

NCT05359718 | Completed

• 1 other identifier: CFTSp196
• Study Type: observational
• Target: 312
• Locations: 1 country
• Sites: 1

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.

Conditions

Solid Tumor

Outcome Measures

Primary Outcomes (5)

• 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

• 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 Outcomes (6)

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

  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 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

• 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

Interventions

Questionnaire OTHER

Questionnaire

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Secondary care

You may qualify if:

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

You may not qualify if:

• \. Patients who lack capacity to participate.

Sponsors & Collaborators

• The Christie NHS Foundation Trust: lead

Study Sites (1)

The Christie NHS Foundation Trust

Manchester, Greater Manchester, M20 4BX, United Kingdom

Location

MeSH Terms

Interventions

Surveys and Questionnaires

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 8, 2021
• First Posted: May 4, 2022
• Study Start: March 1, 2021
• Primary Completion: September 13, 2023
• Study Completion: September 13, 2023
• Last Updated: November 14, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)