Clinical trial NCT05872828: Cross-sectional Study of Chinese Liver Cancer Patients
Official title: Anxiety, Depression, Immune Function and Quality of Life Among Chinese Liver Cancer Patients in the COVID-19 Pandemic Era
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Liver Cancer
Lead sponsor: The Nethersole School of Nursing
Sponsor class: OTHER
First posted: 2023-05-24
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults patients of liver cancer.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Anxiety score
timeFrame: Baseline
measure: Depression score
timeFrame: Baseline
Secondary outcomes:
measure: Quality of life score (The EORTC QLQ-C30)
timeFrame: Baseline
measure: Quality of life score (The EORTC QLQ-HCC18)
timeFrame: Baseline
measure: Immune variables 1
timeFrame: Baseline
measure: Immune variables 2
timeFrame: Baseline
measure: Immune variables 3
timeFrame: Baseline
measure: Immune variables 4
timeFrame: Baseline
measure: Immune variables 5
timeFrame: Baseline
measure: Immune variables 6
timeFrame: Baseline
measure: Immune variables 7
timeFrame: Baseline
measure: Immune variables 8
timeFrame: Baseline
Other outcomes:
Locations:
city: Zhuhai
country: China
facility: Zhuhai People's Hospital
state: Guangdong
Study officials:
affiliation: Chinese University of Hong Kong
name: Hua Yin
role: PRINCIPAL_INVESTIGATOR
References:
citation: Aaronson NK, Ahmedzai S, Bergman B, Bullinger M, Cull A, Duez NJ, Filiberti A, Flechtner H, Fleishman SB, de Haes JC, et al. The European Organization for Research and Treatment of Cancer QLQ-C30: a quality-of-life instrument for use in international clinical trials in oncology. J Natl Cancer Inst. 1993 Mar 3;85(5):365-76. doi: 10.1093/jnci/85.5.365.
citation: 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.
citation: 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.
citation: Antoni MH, Lechner S, Diaz A, Vargas S, Holley H, Phillips K, McGregor B, Carver CS, Blomberg B. Cognitive behavioral stress management effects on psychosocial and physiological adaptation in women undergoing treatment for breast cancer. Brain Behav Immun. 2009 Jul;23(5):580-91. doi: 10.1016/j.bbi.2008.09.005. Epub 2008 Sep 20.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: Dinarello CA. Proinflammatory cytokines. Chest. 2000 Aug;118(2):503-8. doi: 10.1378/chest.118.2.503.