The Impact of Emotional Stress on Immunotherapy Outcomes in Liver Cancer Patients: A Multi-Cohort Study

RecruitingOBSERVATIONAL
Enrollment

700

Participants

Timeline

Start Date

January 1, 2025

Primary Completion Date

December 30, 2027

Study Completion Date

December 31, 2027

Conditions
HCC - Hepatocellular CarcinomaPsychological DistressImmune Checkpoint Inhibitors (ICIs)Cancer, Treatment-RelatedUnresectable Hepatocellular Carcinoma
Interventions
OTHER

Psychological Stress Status

Psychological stress status will be assessed using both self-reported and clinician-rated measures. Participants will be categorized into stressed and non-stressed groups based on the following criteria: Self-reported measures (either): PHQ-9 score ≥ 5 (depression symptoms) and/or; GAD-7 score ≥ 5 (anxiety symptoms) Clinician-rated measures (either): HAMD score ≥ 7 (mild depression) and/or HAMA score ≥ 7 (mild anxiety) Additional assessments: Clinical Global Impression Scale (CGI) EORTC QLQ-C30 (quality of life) Assessment timing: Baseline (before starting immunotherapy) After 2-3 cycles of treatment Every 3 months during follow-up.

OTHER

Psychological Stress Status

Psychological stress status will be assessed using both self-reported and clinician-rated measures. Participants will be categorized into stressed and non-stressed groups based on the following criteria: Self-reported measures (either): PHQ-9 score ≥ 5 (depression symptoms) and/or; GAD-7 score ≥ 5 (anxiety symptoms) Clinician-rated measures (either): HAMD score ≥ 7 (mild depression) and/or HAMA score ≥ 7 (mild anxiety) Additional assessments: Clinical Global Impression Scale (CGI) EORTC QLQ-C30 (quality of life) Assessment timing: Baseline (before starting immunotherapy) After 2-3 cycles of treatment Every 3 months during follow-up.

OTHER

Psychological stress status

Psychological stress status will be assessed using both self-reported and clinician-rated measures. Participants will be categorized into stressed and non-stressed groups based on the following criteria: Self-reported measures (either): PHQ-9 score ≥ 5 (depression symptoms) and/or; GAD-7 score ≥ 5 (anxiety symptoms) Clinician-rated measures (either): HAMD score ≥ 7 (mild depression) and/or HAMA score ≥ 7 (mild anxiety) Additional assessments: Clinical Global Impression Scale (CGI) EORTC QLQ-C30 (quality of life) Assessment timing: Baseline (before starting immunotherapy) After 2-3 cycles of treatment Every 3 months during follow-up.

Trial Locations (5)

422000

RECRUITING

Shaoyang Central Hospital, Shaoyang

RECRUITING

The First Affiliated Hospital of Shaoyang College, Shaoyang

524000

RECRUITING

The Second Affiliated Hospital of Guangdong Medical University, Zhanjiang

541001

RECRUITING

The Affiliated Hospital of Guilin Medical University, Guilin

RECRUITING

The Second Affiliated Hospital of Guilin Medical University, Guilin

All Listed Sponsors
collaborator

the Affiliated hospital of Guilin medical university, China

UNKNOWN

lead

Guilin Medical University, China

OTHER