Postoperative Symptoms in Chinese Liver Cancer Patients: Network Analysis

NCT06419478 | Terminated

• 2 other identifiers: 832423062023AH050604
• Study Type: observational
• Target: 249
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (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.

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

Secondary Outcomes (1)

• Symptom Module Specific for Primary Liver Cancer

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

Study Arms (1)

postoperative symptoms

Investigation of postoperative symptoms in eligible patients undergoing liver resection at two time points

Other: postoperative symptoms

Interventions

postoperative symptoms OTHER

Observational study, focusing solely on symptom surveys of patients.

postoperative symptoms

Eligibility Criteria

• Age: 40 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

Sponsors & Collaborators

• Mengmeng Yuan: lead
• Anhui Medical University: collaborator

Study Sites (1)

Anhui Medical University

Hefei, Anhui, 234000, China

Location

Related Publications (15)

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MeSH Terms

Conditions

Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Study Officials

• shuwen M Li, PhD

  Anhui Medical University

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Research Assistant

Study Record Dates

• First Submitted: May 14, 2024
• First Posted: May 17, 2024
• Study Start: March 1, 2021
• Primary Completion: August 31, 2022
• Study Completion: September 1, 2022
• Last Updated: May 17, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)