Clinical trial NCT06419478: Postoperative Symptoms in Chinese Liver Cancer Patients: Network Analysis
Official title: Exploring Early Postoperative Core Symptoms in Chinese Patients With Primary Liver Cancer: a Cross-sectional and Longitudinal Network Analysis
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Patients With Primary Liver Cancer (PLC) Undergoing Curative Surgical Procedures
Importance of Identifying Core Symptoms for Improving Symptom Management in PLC Patients
Application of Network Analysis as a Crucial Component of Cancer Care
Keywords: Cancer Liver
Hepatectomy
Network analysis
Symptom burden
Lead sponsor: Anhui Medical University
Sponsor class: OTHER
Collaborators: name: Anhui Medical University
First posted: 2024-05-17
Enrollment: 249
Sex: ALL
Minimum age (years): 40
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
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.

Brief 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. 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.


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

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

Primary outcomes:
measure: MD Anderson Symptom Inventory
timeFrame: 1-2 days after surgery (T1) and 1-2 days before discharge (T2).
Secondary outcomes:
measure: Symptom Module Specific for Primary Liver Cancer
timeFrame: 1-2 days after surgery (T1) and 1-2 days before discharge (T2).
Other outcomes:
Locations:
city: Hefei
country: China
facility: Anhui Medical University
state: Anhui
Study officials:
affiliation: Anhui Medical University
name: shuwen M Li, PhD
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.