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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Enrollment
193
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.
Eastern Hepatobiliary Surgery Hospital
Shanghai, China
Overall survival rate
Time frame: The time from enrollment to death caused by any reason, mainly the one-year survival rate
2-year overall survival rate
Time frame: The survival rate from enrollment to two years after intervention
Progression-Free Survival
Time frame: The time from enrollment to disease progression (according to the mRECIST 2010 version) or death caused by any reason, assessed up to 36 months (this study will last for 36 months)
Disease-Free Survival
Time frame: From the date of surgery to disease recurrence, progression, or death due to any cause, whichever occurs first, assessed up to 36 months (this study will last for 36 months)
Objective Response Rate
The proportion of patients achieving complete remission (CR) or partial remission (PR) (according to the mRECIST 2010 version)
Time frame: assessed up to 36 months (this study will last for 36 months)
Disease Control Rate
The proportion of patients achieving complete response (CR), partial response (PR), or stable disease (SD) (according to the mRECIST 2010 version)
Time frame: assessed up to 36 months (this study will last for 36 months)
Treatment-related adverse reactions
From the moment of enrollment. Collected using the PRO-CTCAE (Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events) scale.
Time frame: assessed up to 36 months (this study will last for 36 months)
HCC Quality of life
Collected using the EORTC QLQ-L13 scale
Time frame: assessed up to 36 months (this study will last for 36 months)
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