Ignite Creation Date:
2025-12-24 @ 11:36 PM
Ignite Modification Date:
2025-12-25 @ 9:25 PM
Study NCT ID:
NCT07141056
Status:
RECRUITING
Last Update Posted:
2025-08-26
First Post:
2024-12-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Impact of Emotional Stress on Immunotherapy Outcomes in Liver Cancer Patients: A Multi-Cohort Study
Sponsor:
Guilin Medical University, China
Organization:
Study Overview
Official Title:
Impact of Emotional Stress on Immune Checkpoint Inhibitor Treatment Outcomes in Hepatocellular Carcinoma: A Multicohort Clinical Study
Status:
RECRUITING
Status Verified Date:
2025-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SOLACE
Brief Summary:
The goal of this observational study is to learn if emotional distress affects how well liver cancer treatment works in people receiving immunotherapy. Emotional distress means feeling anxious or depressed. The study aims to answer whether having emotional distress before treatment or changes in emotional distress during treatment affect how well immunotherapy works to treat liver cancer. Researchers will compare participants with and without emotional distress to examine differences in how long the cancer stays under control, treatment response, and overall survival time. Study participants will complete mood and quality of life questionnaires, meet with mental health specialists for emotional assessments, undergo regular blood tests to measure stress hormones, have routine medical check-ups and scans to monitor their cancer status, and be followed for up to 3 years. The study includes three groups of people with liver cancer: those starting immunotherapy for cancer that cannot be removed by surgery, those receiving immunotherapy after surgery, and those receiving immunotherapy before surgery. To be eligible for participation, individuals must be 18 years or older, diagnosed with liver cancer, about to start immunotherapy treatment, and able to complete mood questionnaires.
Detailed Description:
This multi-center prospective cohort study investigates the relationship between emotional distress (ED) and treatment outcomes in patients receiving immune checkpoint inhibitor (ICI) therapy for hepatocellular carcinoma (liver cancer). Recent research suggests that emotional distress may influence how well cancer treatments work, particularly immunotherapy, but this connection hasn't been well studied in liver cancer patients.
Scientific Background: Liver cancer is a major global health concern, with increasing cases worldwide. While immunotherapy has emerged as a promising treatment option, not all patients respond equally well to this therapy. Understanding factors that might influence treatment success is crucial for improving patient care. Recent studies have shown that emotional distress can affect immune system function, which may impact how well immunotherapy works.
Study Design: The study includes three distinct cohorts of liver cancer patients:
Cohort 1: Patients with unresectable liver cancer starting first-line ICI therapy Cohort 2: Patients receiving ICI therapy after surgery (adjuvant therapy) Cohort 3: Patients receiving ICI therapy before surgery (neoadjuvant therapy)
Comprehensive Assessment Approach:
Emotional distress will be evaluated through multiple methods:
Self-reported questionnaires (PHQ-9 for depression and GAD-7 for anxiety) Professional clinical assessments (Hamilton Depression Scale, Hamilton Anxiety Scale, and Clinical Global Impression Scale) Quality of life measurements Biological markers of stress measured through blood tests
Treatment Monitoring: Participants will receive standard-of-care immunotherapy according to their treating physician's recommendations. The study will not influence treatment decisions but will carefully monitor:
Treatment response through regular imaging Side effects Quality of life Changes in emotional well-being Biological markers of stress and immune function Expected Outcomes and Impact: This study aims to: Determine if emotional distress affects treatment outcomes, Identify which patients might benefit from additional psychological support Understand the biological mechanisms linking stress and treatment response, Develop better strategies for supporting patients during immunotherapy Patient Safety and Support: While this is an observational study that doesn't change standard treatment, we recognize that discussing emotional health can be sensitive. The study includes: Regular monitoring of participants' emotional well-being, Access to mental health professionals if needed, Clear protocols for handling any psychological concerns that arise, Protection of patient privacy and confidentiality Long-term Goals: The findings from this study could lead to: Better ways to identify patients who might need extra support during treatment, New strategies to improve treatment effectiveness, More personalized approaches to cancer care that consider both physical and emotional health, Improved understanding of how psychological factors affect cancer treatment Duration and Follow-up: The study will enroll participants over three years, with each participant followed for up to three years. This allows us to understand both immediate and long-term relationships between emotional well-being and treatment outcomes.
Study Innovation: This is one of the first large-scale studies to: Examine the impact of emotional distress on immunotherapy outcomes in liver cancer, Use both patient self-assessments and professional clinical evaluations, Study this relationship across different stages of treatment.
Scientific Background: Liver cancer is a major global health concern, with increasing cases worldwide. While immunotherapy has emerged as a promising treatment option, not all patients respond equally well to this therapy. Understanding factors that might influence treatment success is crucial for improving patient care. Recent studies have shown that emotional distress can affect immune system function, which may impact how well immunotherapy works.
Study Design: The study includes three distinct cohorts of liver cancer patients:
Cohort 1: Patients with unresectable liver cancer starting first-line ICI therapy Cohort 2: Patients receiving ICI therapy after surgery (adjuvant therapy) Cohort 3: Patients receiving ICI therapy before surgery (neoadjuvant therapy)
Comprehensive Assessment Approach:
Emotional distress will be evaluated through multiple methods:
Self-reported questionnaires (PHQ-9 for depression and GAD-7 for anxiety) Professional clinical assessments (Hamilton Depression Scale, Hamilton Anxiety Scale, and Clinical Global Impression Scale) Quality of life measurements Biological markers of stress measured through blood tests
Treatment Monitoring: Participants will receive standard-of-care immunotherapy according to their treating physician's recommendations. The study will not influence treatment decisions but will carefully monitor:
Treatment response through regular imaging Side effects Quality of life Changes in emotional well-being Biological markers of stress and immune function Expected Outcomes and Impact: This study aims to: Determine if emotional distress affects treatment outcomes, Identify which patients might benefit from additional psychological support Understand the biological mechanisms linking stress and treatment response, Develop better strategies for supporting patients during immunotherapy Patient Safety and Support: While this is an observational study that doesn't change standard treatment, we recognize that discussing emotional health can be sensitive. The study includes: Regular monitoring of participants' emotional well-being, Access to mental health professionals if needed, Clear protocols for handling any psychological concerns that arise, Protection of patient privacy and confidentiality Long-term Goals: The findings from this study could lead to: Better ways to identify patients who might need extra support during treatment, New strategies to improve treatment effectiveness, More personalized approaches to cancer care that consider both physical and emotional health, Improved understanding of how psychological factors affect cancer treatment Duration and Follow-up: The study will enroll participants over three years, with each participant followed for up to three years. This allows us to understand both immediate and long-term relationships between emotional well-being and treatment outcomes.
Study Innovation: This is one of the first large-scale studies to: Examine the impact of emotional distress on immunotherapy outcomes in liver cancer, Use both patient self-assessments and professional clinical evaluations, Study this relationship across different stages of treatment.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: