## Protocol Section
### Identification Module
**NCT ID:** NCT06419478

**Acronym:** PSC-LCNA

**Brief Title:** 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

#### Organization Study ID Info
**ID:** 83242306
#### Organization
**Class:** OTHER
**Full Name:** Anhui Medical University
#### Secondary ID Infos
**Domain:** the Natural Science Foundation of Anhui Provincial
**ID:** 2023AH050604
**Type:** OTHER_GRANT
### Status Module
#### Completion Date
**Date:** 2022-09-01

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-17

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-14

**Overall Status:** TERMINATED

#### Primary Completion Date
**Date:** 2022-08-31

**Type:** ACTUAL

#### Start Date
**Date:** 2021-03-01

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-17
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-14
**Study First Submit QC Date:** 2024-05-14
**Why Stopped:** The study stopped because recruitment goals were met ahead of schedule.
### Sponsor Collaborators Module

#### Collaborators

**Class:** OTHER

**Name:** Anhui Medical University

#### Lead Sponsor

**Class:** OTHER

**Name:** Mengmeng Yuan

#### Responsible Party

**Investigator Affiliation:** Anhui Medical University

**Investigator Full Name:** Mengmeng Yuan

**Investigator Title:** Research Assistant

**Type:** SPONSOR_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**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 Module

**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

### Design Module

#### Design Info

**Observational Model:** OTHER

**Time Perspective:** CROSS_SECTIONAL

#### Enrollment Info

**Count:** 249

**Type:** ACTUAL

**Study Type:** OBSERVATIONAL

### Arms Interventions Module

#### Arm Group 1

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

**Intervention Names:**

- Other: postoperative symptoms

**Label:** postoperative symptoms

### Interventions

#### Intervention 1

**Arm Group Labels:**

- postoperative symptoms

**Description:** Observational study, focusing solely on symptom surveys of patients.

**Name:** postoperative symptoms

**Type:** OTHER

### Outcomes Module

#### Primary Outcomes

**Description:** 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.

**Measure:** MD Anderson Symptom Inventory

**Time Frame:** 1-2 days after surgery (T1) and 1-2 days before discharge (T2).

#### Secondary Outcomes

**Description:** 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).

**Measure:** Symptom Module Specific for Primary Liver Cancer

**Time Frame:** 1-2 days after surgery (T1) and 1-2 days before discharge (T2).

### Eligibility Module

**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.

**Maximum Age:** 90 Years

**Minimum Age:** 40 Years

**Sampling Method:** NON_PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- 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.

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Hefei

**Country:** China

**Facility:** Anhui Medical University

**State:** Anhui

**Zip:** 234000

#### Overall Officials

**Official 1:**

**Affiliation:** Anhui Medical University

**Name:** shuwen M Li, PhD

**Role:** STUDY_CHAIR

### IPD Sharing Statement Module

**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.

**IPD Sharing:** NO

### References Module

#### References

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**PMID:** 30465875

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## Derived Section

### Condition Browse Module - Ancestors

- ID: D000004067

- Term: Digestive System Neoplasms

- ID: D000009371

- Term: Neoplasms by Site

- ID: D000009369

- Term: Neoplasms

- ID: D000004066

- Term: Digestive System Diseases

- ID: D000008107

- Term: Liver Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC04

- Name: Neoplasms

- Abbrev: BC06

- Name: Digestive System Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M11113

- Name: Liver Neoplasms

- Relevance: HIGH

- As Found: Liver Cancer

- ID: M8886

- Name: Gastrointestinal Neoplasms

- Relevance: LOW

- As Found: Unknown

- ID: M7256

- Name: Digestive System Neoplasms

- Relevance: LOW

- As Found: Unknown

- ID: M8883

- Name: Gastrointestinal Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M7255

- Name: Digestive System Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M11107

- Name: Liver Diseases

- Relevance: LOW

- As Found: Unknown

- ID: T4700

- Name: Primary Liver Cancer

- Relevance: HIGH

- As Found: Primary liver cancer

- ID: T4202

- Name: Oculocerebral Syndrome With Hypopigmentation

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000008113

- Term: Liver Neoplasms

### Intervention Browse Module - Browse Branches

- Abbrev: Hemat

- Name: Hematinics

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M11110

- Name: Liver Extracts

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-31
