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

NCT ID: NCT04698044

Last Updated: 2021-01-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

1107 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-05-08

Study Completion Date

2020-06-25

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Anxiety Depression Covid19 Cancer Chronic Disease

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Healthy

Have not chronic disease

Hospital Anxiety Depression Scale

Intervention Type DIAGNOSTIC_TEST

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

Hospital Anxiety Depression Scale

Intervention Type DIAGNOSTIC_TEST

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

Hospital Anxiety Depression Scale

Intervention Type DIAGNOSTIC_TEST

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).

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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).

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Elif Yıldırım Ayaz

M.D.

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Sultan Abdülhamid Han Training and Research Hospital

Istanbul, , Turkey (Türkiye)

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Turkey (Türkiye)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

COVFAIROFALL

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.