Cross-sectional Study of Chinese Liver Cancer Patients

NCT05872828 | Unknown

• 1 other identifier: SBRE-22-0307
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

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. 1.To examine the prevalence of anxiety and depression among patients with liver cancer during the COVID-19 pandemic.
2. 2.To identify risk factors associated with anxiety and depression among these patients.
3. 3.To determine the association between anxiety, depression, immune function, and quality of life among liver cancer patients.

Conditions

Liver Cancer

Outcome Measures

Primary Outcomes (2)

• Anxiety score

  Participants' anxiety status with HADS

  Baseline

• Depression score

  Participants' depression status with HADS

  Baseline

Secondary Outcomes (10)

• Quality of life score (The EORTC QLQ-C30)

  Baseline

• Quality of life score (The EORTC QLQ-HCC18)

  Baseline

• Immune variables 1

  Baseline

• Immune variables 2

  Baseline

• Immune variables 3

  Baseline

Interventions

No intervention OTHER

Observational study. No intervention will be adopted.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adults patients of liver cancer.

You may qualify if:

• Participants must meet all the following criteria for study entry:
• Aged 18 or older.
• Participants have a confirmed diagnosis of liver cancer in the medical records.

You may not qualify if:

• Participants who meet any of the following criteria will be excluded from study entry:
• Participant has multiple organ failure which makes him/her incapable to comply with the study protocol.
• Participant has hepatic encephalopathy or severe mental disorder which makes him/her incapable of understanding the meanings of the questionnaires.

Sponsors & Collaborators

• The Nethersole School of Nursing: lead

Study Sites (1)

Zhuhai People's Hospital

Zhuhai, Guangdong, 519000, China

Location

Related Publications (16)

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  PMID: 8433390 BACKGROUND

• Al-Quteimat OM, Amer AM. The Impact of the COVID-19 Pandemic on Cancer Patients. Am J Clin Oncol. 2020 Jun;43(6):452-455. doi: 10.1097/COC.0000000000000712.

  PMID: 32304435 BACKGROUND

• Amiri S, Behnezhad S. Cancer Diagnosis and Suicide Mortality: A Systematic Review and Meta-Analysis. Arch Suicide Res. 2020;24(sup2):S94-S112. doi: 10.1080/13811118.2019.1596182. Epub 2019 May 9.

  PMID: 30955459 BACKGROUND

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  PMID: 18835434 BACKGROUND

• Ayubi E, Bashirian S, Khazaei S. Depression and Anxiety Among Patients with Cancer During COVID-19 Pandemic: A Systematic Review and Meta-analysis. J Gastrointest Cancer. 2021 Jun;52(2):499-507. doi: 10.1007/s12029-021-00643-9. Epub 2021 May 5.

  PMID: 33950368 BACKGROUND

• Blazeby JM, Currie E, Zee BC, Chie WC, Poon RT, Garden OJ; EORTC Quality of Life Group. Development of a questionnaire module to supplement the EORTC QLQ-C30 to assess quality of life in patients with hepatocellular carcinoma, the EORTC QLQ-HCC18. Eur J Cancer. 2004 Nov;40(16):2439-44. doi: 10.1016/j.ejca.2004.06.033.

  PMID: 15519517 BACKGROUND

• Cao MD, Wang H, Shi JF, Bai FZ, Cao MM, Wang YT, Yan XX, Wang L, Huang Z, Ren JS, Zhao JJ, Dai M, Qu CF, Chen WQ. [Disease burden of liver cancer in China: an updated and integrated analysis on multi-data source evidence]. Zhonghua Liu Xing Bing Xue Za Zhi. 2020 Nov 10;41(11):1848-1858. doi: 10.3760/cma.j.cn112338-20200306-00271. Chinese.

  PMID: 33297650 BACKGROUND

• Cao W, Li J, Hu C, Shen J, Liu X, Xu Y, Ye Z. Symptom clusters and symptom interference of HCC patients undergoing TACE: a cross-sectional study in China. Support Care Cancer. 2013 Feb;21(2):475-83. doi: 10.1007/s00520-012-1541-5. Epub 2012 Jul 20.

  PMID: 23010958 BACKGROUND

• Chen G, Wu Q, Jiang H, Zhang H, Peng J, Hu J, Chen M, Zhong Y, Xie C. Fear of disease progression and psychological stress in cancer patients under the outbreak of COVID-19. Psychooncology. 2020 Sep;29(9):1395-1398. doi: 10.1002/pon.5451. Epub 2020 Jul 14. No abstract available.

  PMID: 32596867 BACKGROUND

• Chen W, Zheng R, Baade PD, Zhang S, Zeng H, Bray F, Jemal A, Yu XQ, He J. Cancer statistics in China, 2015. CA Cancer J Clin. 2016 Mar-Apr;66(2):115-32. doi: 10.3322/caac.21338. Epub 2016 Jan 25.

  PMID: 26808342 BACKGROUND

• Cheng C, Chan NY, Chio JH, Chan P, Chan AO, Hui WM. Being active or flexible? Role of control coping on quality of life among patients with gastrointestinal cancer. Psychooncology. 2012 Feb;21(2):211-8. doi: 10.1002/pon.1892. Epub 2010 Dec 19.

  PMID: 22271542 BACKGROUND

• Cheng HH, Kamarck TW, Gianaros PJ, Roecklein KA, Vanegas Y, Tsung A, Geller DA, Marsh JW, Ahmed NS, Steel JL. Socioeconomic disparities of depressive symptoms and cytokines in hepatocellular carcinoma. Psychooncology. 2019 Aug;28(8):1624-1632. doi: 10.1002/pon.5127. Epub 2019 Jun 18.

  PMID: 31119824 BACKGROUND

• Chu TL, Yu WP, Chen SC, Peng HL, Wu MJ. Comparison of differences and determinants between presence and absence of sleep disturbance in hepatocellular carcinoma patients. Cancer Nurs. 2011 Sep-Oct;34(5):354-60. doi: 10.1097/NCC.0b013e3182037bf3.

  PMID: 21242769 BACKGROUND

• Chung MH, Wang SY, Lin CC. Symptom Clusters and Impact of Fatigue and Sleep Disturbance on Symptom Experiences of Hepatoma Patients in Taiwan. Cancer Nurs. 2017 Sep/Oct;40(5):403-411. doi: 10.1097/NCC.0000000000000417.

  PMID: 27472191 BACKGROUND

• Dantzer R. Neuroimmune Interactions: From the Brain to the Immune System and Vice Versa. Physiol Rev. 2018 Jan 1;98(1):477-504. doi: 10.1152/physrev.00039.2016.

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  PMID: 10936147 BACKGROUND

Related Links

• Quality of life questionnaires: EORTC QLQ-C30 \& EORTC QLQ-HCC18.

MeSH Terms

Conditions

Liver Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Liver Diseases

Study Officials

• Hua Yin

  Chinese University of Hong Kong

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 23, 2023
• First Posted: May 24, 2023
• Study Start: April 1, 2023
• Primary Completion: December 31, 2023
• Study Completion: April 30, 2024
• Last Updated: November 22, 2023

Record last verified: 2023-11

Locations

CN (1)