Postoperative Symptoms in Chinese Liver Cancer Patients: Network Analysis (PSC-LCNA)

May 14, 2024 updated by: Mengmeng Yuan

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

249

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Anhui
      • Hefei, Anhui, China, 234000
        • Anhui Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
postoperative symptoms
Investigation of postoperative symptoms in eligible patients undergoing liver resection at two time points
Other: postoperative symptoms
Observational study, focusing solely on symptom surveys of patients.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
MD Anderson Symptom Inventory
Time Frame: 1-2 days after surgery (T1) and 1-2 days before discharge (T2).
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.
1-2 days after surgery (T1) and 1-2 days before discharge (T2).

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Symptom Module Specific for Primary Liver Cancer
Time Frame: 1-2 days after surgery (T1) and 1-2 days before discharge (T2).
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).
1-2 days after surgery (T1) and 1-2 days before discharge (T2).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mengmeng Yuan

Collaborators

Anhui Medical University

Investigators

  • Study Chair: shuwen M Li, PhD, Anhui Medical University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2021

Primary Completion (Actual)

August 31, 2022

Study Completion (Actual)

September 1, 2022

Study Registration Dates

First Submitted

May 14, 2024

First Submitted That Met QC Criteria

May 14, 2024

First Posted (Actual)

May 17, 2024

Study Record Updates

Last Update Posted (Actual)

May 17, 2024

Last Update Submitted That Met QC Criteria

May 14, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 83242306
  • 2023AH050604 (Other Grant/Funding Number: the Natural Science Foundation of Anhui Provincial)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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