Liver Cancer Clinical Trial
Official title:
Anxiety, Depression, Immune Function and Quality of Life Among Chinese Liver Cancer Patients in the COVID-19 Pandemic Era
| Verified date | November 2023 |
| Source | The Nethersole School of Nursing |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational [Patient Registry] |
The goal of this cross-sectional study is to investigate the prevalence and risk factors of anxiety and depression and their relationships with immune functions and quality of life among liver cancer patients in the COVID-19 pandemic era. The objectives of this study are: 1. To examine the prevalence of anxiety and depression among patients with liver cancer during the COVID-19 pandemic. 2. To identify risk factors associated with anxiety and depression among these patients. 3. To determine the association between anxiety, depression, immune function, and quality of life among liver cancer patients. Participants will be asked to fill a digital questionnaire.
| Status | Enrolling by invitation |
| Enrollment | 120 |
| Est. completion date | April 30, 2024 |
| Est. primary completion date | December 31, 2023 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | Inclusion criteria Participants must meet all the following criteria for study entry: 1. Aged 18 or older. 2. Participants have a confirmed diagnosis of liver cancer in the medical records. 3. Participants are able to communicate with Chinese. Exclusion criteria Participants who meet any of the following criteria will be excluded from study entry: 1. Participant has multiple organ failure which makes him/her incapable to comply with the study protocol. 2. Participant has hepatic encephalopathy or severe mental disorder which makes him/her incapable of understanding the meanings of the questionnaires. |
| Country | Name | City | State |
|---|---|---|---|
| China | Zhuhai People's Hospital | Zhuhai | Guangdong |
| Lead Sponsor | Collaborator |
|---|---|
| The Nethersole School of Nursing |
China,
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* Note: There are 16 references in all — Click here to view all references
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Anxiety score | Participants' anxiety status with HADS | Baseline | |
| Primary | Depression score | Participants' depression status with HADS | Baseline | |
| Secondary | Quality of life score (The EORTC QLQ-C30) | The European Organization for Research and Treatment of Cancer(EORTC) Quality of Life Questionnaire results. Scores range from 0 to 100. A higher score represents a higher ("better") level of functioning, or a higher ("worse") level of symptoms. | Baseline | |
| Secondary | Quality of life score (The EORTC QLQ-HCC18) | The Hepatocellular Carcinoma Module of The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire. Scores range from 0 to 100. A higher score represents a high level of symptomatology or problems. | Baseline | |
| Secondary | Immune variables 1 | White blood cell counts (WBC). Collected from daily medical records. | Baseline | |
| Secondary | Immune variables 2 | Total neutrophil count. Collected from daily medical records. | Baseline | |
| Secondary | Immune variables 3 | Total lymphocyte count. Collected from daily medical records. | Baseline | |
| Secondary | Immune variables 4 | Total monocyte count. Collected from daily medical records. | Baseline | |
| Secondary | Immune variables 5 | Neutrophilic granulocyte percentage. Collected from daily medical records. | Baseline | |
| Secondary | Immune variables 6 | Percentage of lymphocytes. Collected from daily medical records. | Baseline | |
| Secondary | Immune variables 7 | Monocyte percentage. Collected from daily medical records. | Baseline | |
| Secondary | Immune variables 8 | C-reactive protein (CRP). Collected from daily medical records. | Baseline |
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