Clinical trial NCT05359718: The Psychological Impact of COVID-19 on Patients with Solid Malignancies: a Single-Institution Survey Study
Official title: The Psychological Impact of COVID-19 on Patients with Solid Malignancies: a Single-Institution Survey Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Solid Tumor
Lead sponsor: The Christie NHS Foundation Trust
Sponsor class: OTHER
First posted: 2022-05-04
Enrollment: 312
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Secondary care

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.


Eligibility criteria: 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.

Primary outcomes:
measure: 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)
timeFrame: 12 months
measure: 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)
timeFrame: 12 months
measure: 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)
timeFrame: 12 months
measure: 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
timeFrame: 12 months
measure: 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
timeFrame: 12 months
Secondary outcomes:
measure: To determine the factors contributing to anxiety, depression and post-traumatic stress during COVID-19 determined by the above questionnaires
timeFrame: 12 months
measure: To determine the factors contributing to anxiety, depression and post-traumatic stress during COVID-19 determined by the above questionnaires
timeFrame: 12 months
measure: To determine the factors contributing to anxiety, depression and post-traumatic stress during COVID-19 determined by the above questionnaires
timeFrame: 12 months
measure: 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
timeFrame: 12 months
measure: 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
timeFrame: 12 months
measure: To correlate the novel well-being thermometer with existing psychometric scales as a screening tool for future patient assessment.
timeFrame: 12 months
Other outcomes:
Locations:
city: Manchester
country: United Kingdom
facility: The Christie NHS Foundation Trust
state: Greater Manchester
Study officials:
References: