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

• Sponsor: The Christie NHS Foundation Trust (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05359718
• Collaborator: (none)
• Enrollment: 150
• Location: 1
• Anticipated Duration (Months): 21
• Patients Per Site Per Month: 7.1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Solid Tumor	Other: Questionnaire

Study Design

• Study Type: Observational
• Anticipated Enrollment: 150 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: The Psychological Impact of COVID-19 on Patients With Solid Malignancies: A Single-Institution Survey Study
• Actual Study Start Date: Mar 1, 2021
• Anticipated Primary Completion Date: Dec 1, 2022
• Anticipated Study Completion Date: Dec 1, 2022

Outcome Measures

Primary Outcome Measures

1. 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 [12 months]

   Psychometric Measure

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 [12 months]

   Psychometric Measure

3. 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 [12 months]

   Psychometric Measure

4. 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 [12 months]

   Psychometric Measure

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 [12 months]

   Psychometric Measure

Secondary Outcome Measures

1. To determine the factors contributing to anxiety, depression and post-traumatic stress during COVID-19 determined by the above questionnaires [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 [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 [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 [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 [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. [12 months]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The Christie NHS Foundation Trust	Manchester	Greater Manchester	United Kingdom	M20 4BX

Sponsors and Collaborators

• The Christie NHS Foundation Trust

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: The Christie NHS Foundation Trust
• ClinicalTrials.gov Identifier: NCT05359718
• Other Study ID Numbers: CFTSp196
• First Posted: May 4, 2022
• Last Update Posted: May 4, 2022
• Last Verified: May 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Neoplasms

Study Results

No Results Posted as of May 4, 2022