Actively Recruiting
Cohort Studies of Associations of Psychological Stress With Therapy Efficacy and Prognosis of Gastric Cancer (G-STRESS)
Led by Fudan University · Updated on 2025-01-22
600
Participants Needed
1
Research Sites
156 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying the relationship between psychological stress and treatment outcomes in patients with gastric and gastroesophageal junction cancer. This observational cohort study, called G-Distress, includes patients receiving surgery, chemotherapy, and immune checkpoint inhibitors. It aims to explore how stress affects therapy effectiveness and prognosis in different stages of gastric cancer. The study divides participants into three groups based on their treatment: advanced gastric cancer patients undergoing surgery, stage III-IV patients receiving preoperative treatment, and stage IV patients treated with chemotherapy or immunotherapy. Psychological stress levels are assessed using questionnaires for depressive and anxiety symptoms. Patients scoring above certain thresholds are classified as stressed. Participants are monitored over time with assessments of disease-free survival, pathologic complete response, and progression-free survival, depending on their group. Additional measures include overall survival, treatment response rates, and quality of life evaluations over up to three years. The study collects data through clinical follow-ups to understand the impact of stress on cancer treatment and outcomes.
CONDITIONS
Brief Title
The Relationship of Psychological Stress With Therapy Efficacy and Prognosis of Gastric Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 80 years old with ECOG performance status of 0 or 1
- Diagnosed with primary adenocarcinoma of gastric cancer
- Cohort 1: Stage II-III, received R0 gastrectomy with D2 lymphadenectomy and adjuvant chemotherapy
- Cohort 2: Stage III-IV, receiving gastrectomy and preoperative chemotherapy
- Cohort 3: Stage IV, unavailable for gastrectomy with at least one measurable lesion
You will not qualify if you...
- History of chemotherapy, radiotherapy, immunotherapy, or targeted therapy before study for Cohort 1
- Multiple primary tumors
- Serious other diseases including cardiovascular, respiratory, kidney, or liver disease with poorly controlled hypertension, diabetes, or mental disorders
- Unavailable for required surgeries or treatments specific to each cohort
- Patients with stage IV gastric cancer in Cohort 1
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Up to 3 years depending on cohort
Participants are observed to assess psychological stress status and track therapy efficacy and prognosis based on their treatment cohort.
Regular assessments depending on cohort treatment and follow-up schedules
Trial Site Locations
Total: 1 location
1
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China, 200000
Actively Recruiting
Research Team
J
Jing Guo, MD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
3
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