- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04698044
Anxiety and Depression Perceived by Individuals With and Without Cancer During the COVID-19 Pandemic Period
Anxiety and Depression Perceived by Individuals With and Without Cancer During the COVID-19 Pandemic Period: A Population-based Comparative Study
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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-
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Istanbul, Turkey, 34660
- Sultan Abdülhamid Han Training and Research Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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.
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Cross-Sectional
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Healthy
Have not chronic disease
|
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
|
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
|
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).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
HADS
Time Frame: 14 days
|
The score of Hospital Anxiety Depression Scale
|
14 days
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Behavioral Symptoms
- Mental Disorders
- Pathologic Processes
- Coronavirus Infections
- Coronaviridae Infections
- Nidovirales Infections
- RNA Virus Infections
- Virus Diseases
- Infections
- Respiratory Tract Infections
- Respiratory Tract Diseases
- Mood Disorders
- Pneumonia, Viral
- Pneumonia
- Lung Diseases
- Disease Attributes
- Depression
- Depressive Disorder
- COVID-19
- Anxiety Disorders
- Chronic Disease
Other Study ID Numbers
- COVFAIROFALL
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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