Cross-sectional Study of Chinese Liver Cancer Patients

Sponsor
The Nethersole School of Nursing (Other)
Overall Status
Recruiting
CT.gov ID
NCT05872828
Collaborator
(none)
120
1
9
13.3

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Other: No intervention

Study Design

Study Type:
Observational [Patient Registry]
Anticipated Enrollment :
120 participants
Observational Model:
Case-Only
Time Perspective:
Cross-Sectional
Official Title:
Anxiety, Depression, Immune Function and Quality of Life Among Chinese Liver Cancer Patients in the COVID-19 Pandemic Era
Actual Study Start Date :
Apr 1, 2023
Anticipated Primary Completion Date :
Jul 31, 2023
Anticipated Study Completion Date :
Dec 31, 2023

Outcome Measures

Primary Outcome Measures

  1. Anxiety score [Baseline]

    Participants' anxiety status with HADS

  2. Depression score [Baseline]

    Participants' depression status with HADS

Secondary Outcome Measures

  1. Quality of life score (The EORTC QLQ-C30) [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.

  2. Quality of life score (The EORTC QLQ-HCC18) [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.

  3. Immune variables 1 [Baseline]

    White blood cell counts (WBC). Collected from daily medical records.

  4. Immune variables 2 [Baseline]

    Total neutrophil count. Collected from daily medical records.

  5. Immune variables 3 [Baseline]

    Total lymphocyte count. Collected from daily medical records.

  6. Immune variables 4 [Baseline]

    Total monocyte count. Collected from daily medical records.

  7. Immune variables 5 [Baseline]

    Neutrophilic granulocyte percentage. Collected from daily medical records.

  8. Immune variables 6 [Baseline]

    Percentage of lymphocytes. Collected from daily medical records.

  9. Immune variables 7 [Baseline]

    Monocyte percentage. Collected from daily medical records.

  10. Immune variables 8 [Baseline]

    C-reactive protein (CRP). Collected from daily medical records.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No

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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Zhuhai People's Hospital Zhuhai Guangdong China 519000

Sponsors and Collaborators

  • The Nethersole School of Nursing

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

Responsible Party:
Hua Yin, Principal Investigator, The Nethersole School of Nursing
ClinicalTrials.gov Identifier:
NCT05872828
Other Study ID Numbers:
  • SBRE-22-0307
First Posted:
May 24, 2023
Last Update Posted:
May 24, 2023
Last Verified:
May 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 24, 2023