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Patients With Primary Liver Cancer (PLC) Undergoing Curative Surgical ProceduresPSC-LCNANCT06419478

Postoperative Symptoms in Chinese Liver Cancer Patients: Network Analysis

An observational study of Patients With Primary Liver Cancer (PLC) Undergoing Curative Surgical Procedures and Importance of Identifying Core Symptoms for Improving Symptom Management in PLC Patients, run by Mengmeng Yuan at 1 site in China.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

Patients with primary liver cancer (PLC) experience a range of symptoms in the early postoperative period. Symptoms include cancer-related symptoms and adverse effects of treatment. Read more about this study

Who is it for?
Ages 40 to 90 years
What is being tested?
postoperative symptoms
How many people
249 participants
Where
1 siteChina
Study dates
1 Mar 2021to 1 Sep 2022
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 40 to 90 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Participants with PLC who underwent curative surgical procedures between March 2021 and September 2022 at the Hepatobiliary Surgery Departments of two Eastern Chinese hospitals.

Who may be able to join

  • Eligible patients were ≥18 years of age; had a diagnosis of primary liver cancer based on pathologic examination; were receiving the first hepatectomy; were conscious, spoke Chinese, and had basic communication skills.

Who cannot join

  • Exclusion criteria include concurrent malignant tumors, mental disorders, or consciousness impairments, as well as participation in other clinical interventions.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Anhui Medical University

    Hefei, Anhui, 234000

Other trials in China

About this study

Official title: Exploring Early Postoperative Core Symptoms in Chinese Patients With Primary Liver Cancer: a Cross-sectional and Longitudinal Network Analysis

Patients with primary liver cancer (PLC) experience a range of symptoms in the early postoperative period. Symptoms include cancer-related symptoms and adverse effects of treatment. Exploring the core symptoms and their dynamics in the early post-hepatectomy patients may help provide better symptom management programs. The purpose of this study was to identify the core symptoms in early post-hepatectomy patients and to explore the trajectory of their dynamics. During the period from March 2021 to September 2022, a total of 281 patients diagnosed with PLC and undergoing radical curative surgery were recruited from the hepatobiliary surgery departments of two hospitals in Eastern China, among whom 249 individuals (88.60%) agreed to participate in the study. A comprehensive symptom assessment was administered to the patients 1-2 days after surgery (T1) and 1-2 days before discharge (T2). Network analysis was used to identify core symptoms in early post-hepatectomy patients based on symptom severity.

Being tested
postoperative symptoms
Keywords
Cancer Liver, Hepatectomy, Network analysis, Symptom burden
Medical subject headings
Carcinoma, Hepatocellular

What participants receive

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

  • postoperative symptomsOther

    Observational study, focusing solely on symptom surveys of patients.

Study groups in NCT06419478
Study groupRoleWhat they receive
postoperative symptomsInvestigation of postoperative symptoms in eligible patients undergoing liver resection at two time points
Receives: Other: postoperative symptoms

What is being measured

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

  1. MD Anderson Symptom Inventory

    The MD Anderson Symptom Inventory (MDASI) is one of the most widely used symptom assessment tools for cancer patients in clinical and research settings and is used to evaluate the severity of symptoms and their impact on daily life. It consists of 13 core symptom items and 6 symptom interference items. The severity of each symptom is rated on an 11-point Likert scale (0 = "not at all" and 10 = "as bad as you can imagine"). The MDASI-C, a Chinese version translated in 2004 by Wang et al., has good reliability, with a Cronbach's alpha of 0.82-0.94.

    Measured: 1-2 days after surgery (T1) and 1-2 days before discharge (T2).

Secondary outcomes (1)

  1. Symptom Module Specific for Primary Liver Cancer

    The Symptom Module Specific for Primary Liver Cancer (TSM-PLC) can serve as an important supplement to the MDASI, providing instrumental security for the systematic assessment of symptoms in patients PLC. It consists of six symptom items: abdominal distension, diarrhea, loss of weight, jaundice, pruritus, and fever. The six items were rated in the same format as the first part of the MDASI. The TSM-PLC has good reliability (Cronbach's alpha of 0.835 for internal consistency and content validity of 0.91).

    Measured: 1-2 days after surgery (T1) and 1-2 days before discharge (T2).

Timeline

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

  1. First posted17 May 2024
  2. Study start1 Mar 2021
  3. Primary completion31 Aug 2022
  4. Study completion1 Sep 2022

Why it stopped: The study stopped because recruitment goals were met ahead of schedule.

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
Other
Time perspective
Cross-sectional
Enrolment
249 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06419478
Sponsor's protocol ID
83242306
Other IDs
2023AH050604
Acronym
PSC-LCNA
Status last verified
May 2024
First submitted
14 May 2024
Last updated
17 May 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: We do not plan to share individual participant data (Share IPD) to protect participant privacy. However, individuals who support the findings of this study may contact the study's principal investigator directly to request data.

Publications

  • Zhu Z, Hu Y, Xing W, Guo M, Zhao R, Han S, Wu B. Identifying Symptom Clusters Among People Living With HIV on Antiretroviral Therapy in China: A Network Analysis. J Pain Symptom Manage. 2019 Mar;57(3):617-626. doi: 10.1016/j.jpainsymman.2018.11.011. Epub 2018 Nov 20.

    PubMed 30465875

  • Wang XS, Wang Y, Guo H, Mendoza TR, Hao XS, Cleeland CS. Chinese version of the M. D. Anderson Symptom Inventory: validation and application of symptom measurement in cancer patients. Cancer. 2004 Oct 15;101(8):1890-901. doi: 10.1002/cncr.20448.

    PubMed 15386315

  • Sung H, Ferlay J, Siegel RL, Laversanne M, Soerjomataram I, Jemal A, Bray F. Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries. CA Cancer J Clin. 2021 May;71(3):209-249. doi: 10.3322/caac.21660. Epub 2021 Feb 4.

    PubMed 33538338

  • Devarbhavi H, Asrani SK, Arab JP, Nartey YA, Pose E, Kamath PS. Global burden of liver disease: 2023 update. J Hepatol. 2023 Aug;79(2):516-537. doi: 10.1016/j.jhep.2023.03.017. Epub 2023 Mar 27.

    PubMed 36990226

  • Zou H, Li M, Lei Q, Luo Z, Xue Y, Yao D, Lai Y, Ung COL, Hu H. Economic Burden and Quality of Life of Hepatocellular Carcinoma in Greater China: A Systematic Review. Front Public Health. 2022 Apr 21;10:801981. doi: 10.3389/fpubh.2022.801981. eCollection 2022.

    PubMed 35530735

  • Liu D, Song T. Changes in and challenges regarding the surgical treatment of hepatocellular carcinoma in China. Biosci Trends. 2021 Jul 6;15(3):142-147. doi: 10.5582/bst.2021.01083. Epub 2021 Mar 14.

    PubMed 33716267

  • Drott J, Bjornsson B, Sandstrom P, Bertero C. Experiences of Symptoms and Impact on Daily Life and Health in Hepatocellular Carcinoma Patients: A Meta-synthesis of Qualitative Research. Cancer Nurs. 2022 Nov-Dec 01;45(6):430-437. doi: 10.1097/NCC.0000000000001044. Epub 2022 Jan 13.

    PubMed 35025775

  • Ellis J, Brearley SG, Craven O, Molassiotis A. Understanding the symptom experience of patients with gastrointestinal cancers in the first year following diagnosis: findings from a qualitative longitudinal study. J Gastrointest Cancer. 2013 Mar;44(1):60-7. doi: 10.1007/s12029-012-9443-9.

    PubMed 23054580

  • Ryu E, Kim K, Cho MS, Kwon IG, Kim HS, Fu MR. Symptom clusters and quality of life in Korean patients with hepatocellular carcinoma. Cancer Nurs. 2010 Jan-Feb;33(1):3-10. doi: 10.1097/NCC.0b013e3181b4367e.

    PubMed 19926981

  • Patel N, Maher J, Lie X, Gwaltney C, Barzi A, Karwal M, Macarulla T, Sun HC, Trojan J, Meyers O, Workman C, Morgan S, Negro A, Cohen G. Understanding the patient experience in hepatocellular carcinoma: a qualitative patient interview study. Qual Life Res. 2022 Feb;31(2):473-485. doi: 10.1007/s11136-021-02903-4. Epub 2021 Jun 11.

    PubMed 34115280

  • Zhu Z, Sun Y, Kuang Y, Yuan X, Gu H, Zhu J, Xing W. Contemporaneous symptom networks of multidimensional symptom experiences in cancer survivors: A network analysis. Cancer Med. 2023 Jan;12(1):663-673. doi: 10.1002/cam4.4904. Epub 2022 Jun 1.

    PubMed 35651298

  • Cha EJ, Hong S, Park DH, Ryu SH, Ha JH, Jeon HJ. A network analysis of panic symptoms in relation to depression and anxiety sensitivity in patients with panic disorder. J Affect Disord. 2022 Jul 1;308:134-140. doi: 10.1016/j.jad.2022.04.062. Epub 2022 Apr 13.

    PubMed 35429524

  • Zeng L, Huang H, Liu Y, Ruan C, Fan S, Xia Y, Zhou J. The core symptom in multiple myeloma patients undergoing chemotherapy: a network analysis. Support Care Cancer. 2023 Apr 25;31(5):297. doi: 10.1007/s00520-023-07759-7.

    PubMed 37097532

  • Bai W, Cai H, Wu S, Zhang L, Feng KX, Li YC, Liu HZ, Du X, Zeng ZT, Lu CM, Mi WF, Zhang L, Ding YH, Yang JJ, Jackson T, Cheung T, An FR, Xiang YT. Internet addiction and its association with quality of life in patients with major depressive disorder: a network perspective. Transl Psychiatry. 2022 Apr 4;12(1):138. doi: 10.1038/s41398-022-01893-2.

    PubMed 35379778

  • Cleeland CS, Mendoza TR, Wang XS, Chou C, Harle MT, Morrissey M, Engstrom MC. Assessing symptom distress in cancer patients: the M.D. Anderson Symptom Inventory. Cancer. 2000 Oct 1;89(7):1634-46. doi: 10.1002/1097-0142(20001001)89:73.0.co;2-v.

    PubMed 11013380

Questions about this trial

What is this clinical trial studying?

An observational study of Patients With Primary Liver Cancer (PLC) Undergoing Curative Surgical Procedures and Importance of Identifying Core Symptoms for Improving Symptom Management in PLC Patients, run by Mengmeng Yuan 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 1 inclusion and 1 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: stopped early, as of the sponsor's last update on 17 May 2024. 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?

The study was stopped early (reason given: The study stopped because recruitment goals were met ahead of schedule.). 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?

MD Anderson Symptom Inventory (time frame: 1-2 days after surgery (T1) and 1-2 days before discharge (T2).). 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 NCT06419478, which also lists 15 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 17 May 2024.

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