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Anxiety and Depression Perceived by Individuals With and Without Cancer During the COVID-19 Pandemic Period

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04698044
Recruitment Status : Completed
First Posted : January 6, 2021
Last Update Posted : January 7, 2021
Sponsor:
Information provided by (Responsible Party):
Elif Yıldırım Ayaz, Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey

Study Description
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Brief Summary:
The COVID-19 pandemic has negatively affected individuals not only physiologically but also psychologically. The aim of this study is to examine the anxiety and depression status of cancer patients, individuals with non-cancer chronic diseases and healthy individuals with an online screening questionnaire during the COVID-19 pandemic period.

Condition or disease Intervention/treatment
Anxiety Depression Covid19 Cancer Chronic Disease Diagnostic Test: Hospital Anxiety Depression Scale

Detailed Description:

Our aim is to evaluate and compare the anxiety and depression status of cancer patients, individuals with non-chronic chronic diseases and healthy individuals during the COVID-19 period with an online screening program.

A simple random sampling method performed by a computer was used in selecting the participants from 7,000 people whose information was available in the hospital automation system. The computer program enumerates the items in the sampling frame, determines its own random numbers, and presents the selected items to the researcher in writing or digitally (Newman & Ridenour, 1998).

The sample groups were randomly selected from cancer patients, patients with non-cancer chronic diseases and those without any diseases. The study included individuals who were aged 18 years and above, volunteered to participate in the study and were literate. The diagnoses recorded in the electronic medical records of the patients were examined, and those diagnosed with psychiatric diseases (depression, mania, bipolar disorder, psychosis, obsessive-compulsive disorder, etc.), mental retardation, dementia, and Alzheimer's disease were excluded. In addition, the questionnaire questions include the question of the presence of existing psychiatric and neurological diseases. The patient was excluded from the study also if these diagnoses were reported by the patient. Moreover, the participation of the patient in the study was not allowed in the presence of both cancer and a non-cancer chronic disease. Non-cancer chronic diseases were defined as diabetes mellitus, hypertension, neurological diseases, asthma, chronic obstructive pulmonary disease (COPD), other pulmonary diseases, cardiovascular diseases, and hypothyroidism. Other patients who used chronic medication and/or were followed up for any chronic disease (rheumatic disease, endocrinal disorders, liver disease, kidney diseases) were classified as other chronic diseases. Approval was taken from the University of Health Sciences, XXX Ethics Committee (approval number: 20/133) before the study commenced. The patients were called with phone and confirmed whether they wanted to participate in the study, and their consents were obtained. Individuals who wanted to participate in the study was informed about the purpose of the study, procedure and data privacy, and told that participation was on a voluntary basis, and individuals could leave the research at any time they wanted. Individuals read and signed their consent forms online. The study was conducted in compliance with the "Ethical principles for medical research involving human subjects" of the Helsinki Declaration. All data were collected with Survey Monkey (2005 SurveyMonkey.com), which provides electronic self-control, prevents multiple entries from the same person, and makes it easier to collect and track data (last data entry: 07/06/2020). Confidentiality was guaranteed by completely deactivating electronic records and IP address records.

Study Design
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Study Type : Observational
Actual Enrollment : 1107 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Anxiety and Depression Perceived by Individuals With and Without Cancer During the COVID-19 Pandemic Period: A Population-based Comparative Study
Actual Study Start Date : May 8, 2020
Actual Primary Completion Date : June 25, 2020
Actual Study Completion Date : June 25, 2020

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
Healthy
Have not chronic disease
 Diagnostic Test: Hospital Anxiety Depression Scale
HADS is a self-report questionnaire designed to screen the symptoms of anxiety and depression in individuals with medical diseases other than psychiatric illnessesHADS is a self-report questionnaire designed to screen the symptoms of anxiety and depression in individuals with medical diseases other than psychiatric illnesses The 4-point Likert type scale, which consists of 14 items, has 2 subscales. Each of the HADS-Anxiety (HADS-A) and HADS-Depression (HADS-D) subscales has 7 items. The score given for each question varies between 0 and 3. A high score indicates a high level of anxiety and depression. The responses given to the questions are given certain scores, and as a result, a score of 0-7 refers to a normal level, 8-10 to a level at the limit and 11 and above to a high level (abnormal level).
Cancer
Have cancer
 Diagnostic Test: Hospital Anxiety Depression Scale
HADS is a self-report questionnaire designed to screen the symptoms of anxiety and depression in individuals with medical diseases other than psychiatric illnessesHADS is a self-report questionnaire designed to screen the symptoms of anxiety and depression in individuals with medical diseases other than psychiatric illnesses The 4-point Likert type scale, which consists of 14 items, has 2 subscales. Each of the HADS-Anxiety (HADS-A) and HADS-Depression (HADS-D) subscales has 7 items. The score given for each question varies between 0 and 3. A high score indicates a high level of anxiety and depression. The responses given to the questions are given certain scores, and as a result, a score of 0-7 refers to a normal level, 8-10 to a level at the limit and 11 and above to a high level (abnormal level).
Non-Cancer Crhronic Disease
Have non-cancer chronic disease
 Diagnostic Test: Hospital Anxiety Depression Scale
HADS is a self-report questionnaire designed to screen the symptoms of anxiety and depression in individuals with medical diseases other than psychiatric illnessesHADS is a self-report questionnaire designed to screen the symptoms of anxiety and depression in individuals with medical diseases other than psychiatric illnesses The 4-point Likert type scale, which consists of 14 items, has 2 subscales. Each of the HADS-Anxiety (HADS-A) and HADS-Depression (HADS-D) subscales has 7 items. The score given for each question varies between 0 and 3. A high score indicates a high level of anxiety and depression. The responses given to the questions are given certain scores, and as a result, a score of 0-7 refers to a normal level, 8-10 to a level at the limit and 11 and above to a high level (abnormal level).


Outcome Measures
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Primary Outcome Measures :
  1. HADS [ Time Frame: 14 days ]
    The score of Hospital Anxiety Depression Scale


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
The sample groups were randomly selected from cancer patients, patients with non-cancer chronic diseases and those without any diseases
Criteria

Inclusion Criteria:

  • Cancer patients, patients with non-cancer chronic diseases and those without any diseases
  • 18 years or above
  • Literate

Exclusion Criteria:

  • Psychiatric diseases (depression, mania, bipolar disorder, psychosis, obsessive-compulsive disorder, etc.)
  • Mental retardation
  • Dementia
  • Alzheimer's disease were excluded.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04698044


Locations
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Turkey
Sultan Abdülhamid Han Training and Research Hospital
Istanbul, Turkey, 34660
Sponsors and Collaborators
Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey
More Information
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Responsible Party: Elif Yıldırım Ayaz, M.D., Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey
ClinicalTrials.gov Identifier: NCT04698044    
Other Study ID Numbers: COVFAIROFALL
First Posted: January 6, 2021    Key Record Dates
Last Update Posted: January 7, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Elif Yıldırım Ayaz, Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey:
anxiety
depression
covid-19
cancer
chronic disease
Additional relevant MeSH terms:
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COVID-19
Chronic Disease
Depression
Depressive Disorder
Anxiety Disorders
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
 Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases
Behavioral Symptoms
Mood Disorders
Mental Disorders
Disease Attributes
Pathologic Processes