Cross-sectional Study of Chinese Liver Cancer Patients

November 21, 2023 updated by: Hua Yin, The Nethersole School of Nursing

Anxiety, Depression, Immune Function and Quality of Life Among Chinese Liver Cancer Patients in the COVID-19 Pandemic Era

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.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

120

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Guangdong
      • Zhuhai, Guangdong, China, 519000
        • Zhuhai People's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Adults patients of liver cancer.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Anxiety score
Time Frame: Baseline
Participants' anxiety status with HADS
Baseline
Depression score
Time Frame: Baseline
Participants' depression status with HADS
Baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of life score (The EORTC QLQ-C30)
Time Frame: Baseline
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
Quality of life score (The EORTC QLQ-HCC18)
Time Frame: Baseline
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
Immune variables 1
Time Frame: Baseline
White blood cell counts (WBC). Collected from daily medical records.
Baseline
Immune variables 2
Time Frame: Baseline
Total neutrophil count. Collected from daily medical records.
Baseline
Immune variables 3
Time Frame: Baseline
Total lymphocyte count. Collected from daily medical records.
Baseline
Immune variables 4
Time Frame: Baseline
Total monocyte count. Collected from daily medical records.
Baseline
Immune variables 5
Time Frame: Baseline
Neutrophilic granulocyte percentage. Collected from daily medical records.
Baseline
Immune variables 6
Time Frame: Baseline
Percentage of lymphocytes. Collected from daily medical records.
Baseline
Immune variables 7
Time Frame: Baseline
Monocyte percentage. Collected from daily medical records.
Baseline
Immune variables 8
Time Frame: Baseline
C-reactive protein (CRP). Collected from daily medical records.
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Nethersole School of Nursing

Investigators

  • Principal Investigator: Hua Yin, Chinese University of Hong Kong

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2023

Primary Completion (Estimated)

December 31, 2023

Study Completion (Estimated)

April 30, 2024

Study Registration Dates

First Submitted

March 23, 2023

First Submitted That Met QC Criteria

May 14, 2023

First Posted (Actual)

May 24, 2023

Study Record Updates

Last Update Posted (Actual)

November 22, 2023

Last Update Submitted That Met QC Criteria

November 21, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SBRE-22-0307

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

Clinical Trials on Liver Cancer

Clinical Trials on No intervention

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Belarus

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe