A Trial of Behavioral Intervention on Prognostic Survival of Patients With Unresectable Liver Cancer

NCT ID: NCT07337031

Last Updated: 2026-01-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

193 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-01-31

Study Completion Date

2028-12-31

Brief Summary

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Research purpose

1. To evaluate the impact of complex behavioral intervention on the one-year overall survival rate of patients with unresectable liver cancer after comprehensive treatment, a comparative study was conducted between the complex behavioral intervention group and the standard medical care control group, and the dose-response relationship between the intervention intensity and clinical outcomes was explored.
2. Analyze the impact mechanisms of complex behavioral interventions on patients' quality of life, adverse treatment reactions, and key biological indicators, including evaluating clinical outcomes such as 2-year overall survival rate, progression-free survival (PFS), objective response rate (ORR), and disease control rate (DCR), as well as the association between changes in related biomarkers and behavioral compliance.
3. Evaluate the implementation effect and sustainability of the "in-hospital face-to-face + wechat platform" hybrid intervention model, including intervention acceptance, long-term behavior maintenance, health economic benefits, and perioperative recovery of patients undergoing down-conversion surgery.

Detailed Description

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Conditions

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Primary Hepatocellular Carcinoma Unresectable Liver Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Participants

Study Groups

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complex intervention group

Group Type EXPERIMENTAL

complex behavioral intervention

Intervention Type BEHAVIORAL

Including behavioral intervention measures such as alcohol cessation management, smoking cessation and respiratory function training, nutrition management, exercise management, blood sugar and weight management, sleep management, pain management, wound and infection management, mindfulness meditation and mental health management.

routine care group

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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complex behavioral intervention

Including behavioral intervention measures such as alcohol cessation management, smoking cessation and respiratory function training, nutrition management, exercise management, blood sugar and weight management, sleep management, pain management, wound and infection management, mindfulness meditation and mental health management.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

1. Pathologically or radiologically confirmed primary hepatocellular carcinoma;
2. BCLC stage B-C, initially assessed as unresectable;
3. Age 18-75 years;
4. ECOG performance status score 0-2;
5. Child-Pugh classification grade A or B (\<=9 points);
6. Normal cognitive ability, capable of understanding and following intervention protocols;
7. Both the patient and primary caregiver can use a smartphone and the WeChat platform and are able to complete questionnaires and follow-up tasks;
8. Voluntarily participates in the study and signs the informed consent form.

Exclusion Criteria

1. Presence of malignant tumors in other organs;
2. Presence of extrahepatic metastasis;
3. Presence of any of the following severe organic diseases in any organ:

(1) Cardiovascular: NYHA class III-IV heart failure, acute coronary syndrome within the past 6 months; (2) Liver: Child-Pugh class C cirrhosis, or ALT/AST \>5 times the upper limit of normal; (3) Kidney: eGFR \<45 mL/min/1.73m\^2 or dialysis-dependent; (4) Respiratory: respiratory failure requiring long-term oxygen therapy; (5) Hematologic: hemoglobin \<9 g/dL or platelets \<75×10\^9/L; 4. History of psychiatric disorders, severe cognitive impairment, or substance abuse; 5. Previous liver transplantation or treatment for malignant liver tumors; 6. Complete thrombosis of the main portal vein; 7. Female patients who are pregnant or breastfeeding; 8. Presence of severe congenital or acquired immunodeficiency; 9. Unwillingness to sign the informed consent form; 10. Other conditions deemed unsuitable for participation in this study by the investigator.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Eastern Hepatobiliary Surgery Hospital

OTHER

Sponsor Role lead

Responsible Party

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Luo Susu

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Eastern Hepatobiliary Surgery Hospital

Shanghai, , China

Site Status

Countries

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China

Central Contacts

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Hui Liu

Role: CONTACT

021-81887715

Susu Luo

Role: CONTACT

+(1)314-775-6241

Facility Contacts

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Hui Liu

Role: primary

021-81887715

Other Identifiers

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25ZR1402578

Identifier Type: -

Identifier Source: org_study_id

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