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AzTrials

Liver CancerNCT05872828

Cross-sectional Study of Chinese Liver Cancer Patients

An observational study of Liver Cancer, run by The Nethersole School of Nursing at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Liver Cancer
How many people
120 participants
Where
1 siteChina
Study dates
1 Apr 2023to 30 Apr 2024
How long will I take part?
1 Day
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Adults patients of liver cancer.

Who may be able to join

  • 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.
  • Participants are able to communicate with Chinese. Exclusion criteria
  • 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.

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Zhuhai People's Hospital

    Zhuhai, Guangdong, 519000

Other trials in China

About this study

Official title: 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.

Conditions
Liver Cancer
Being tested
No intervention
Medical subject headings
Liver Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • No interventionOther

    Observational study. No intervention will be adopted.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Anxiety score

    Participants' anxiety status with HADS

    Measured: Baseline

  2. Depression score

    Participants' depression status with HADS

    Measured: Baseline

Secondary outcomes (10)

  1. 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.

    Measured: Baseline

  2. 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.

    Measured: Baseline

  3. Immune variables 1

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

    Measured: Baseline

  4. Immune variables 2

    Total neutrophil count. Collected from daily medical records.

    Measured: Baseline

  5. Immune variables 3

    Total lymphocyte count. Collected from daily medical records.

    Measured: Baseline

  6. Immune variables 4

    Total monocyte count. Collected from daily medical records.

    Measured: Baseline

  7. Immune variables 5

    Neutrophilic granulocyte percentage. Collected from daily medical records.

    Measured: Baseline

  8. Immune variables 6

    Percentage of lymphocytes. Collected from daily medical records.

    Measured: Baseline

  9. Immune variables 7

    Monocyte percentage. Collected from daily medical records.

    Measured: Baseline

  10. Immune variables 8

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

    Measured: Baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 May 2023
  2. Study start1 Apr 2023
  3. Primary completion31 Dec 2023 (estimated)
  4. Study completion30 Apr 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Cross-sectional
Enrolment
120 participants (estimated)
Target duration
1 Day
IDs, dates and publications
ClinicalTrials.gov ID
NCT05872828
Sponsor's protocol ID
SBRE-22-0307
Status last verified
Nov 2023
First submitted
23 Mar 2023
Last updated
22 Nov 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 8433390

  • 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.

    PubMed 32304435

  • 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.

    PubMed 30955459

  • 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.

    PubMed 18835434

  • 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.

    PubMed 33950368

  • 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.

    PubMed 15519517

  • 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.

    PubMed 33297650

  • 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.

    PubMed 23010958

  • 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.

    PubMed 32596867

  • 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.

    PubMed 26808342

  • 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.

    PubMed 22271542

  • 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.

    PubMed 31119824

  • 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.

    PubMed 21242769

  • 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.

    PubMed 27472191

  • 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.

    PubMed 29351513

Questions about this trial

What is this clinical trial studying?

An observational study of Liver Cancer, run by The Nethersole School of Nursing at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 22 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Anxiety score (time frame: Baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05872828, which also lists 16 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Nov 2023.

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