Actively Recruiting
Psychological Stress and Its Effects on Treatment and Outcomes in Gastric Cancer A Prospective Observational Cohort Study (G-STRESS)
Led by Fudan University · Updated on 2025-01-22
600
Participants Needed
1
Research Sites
262 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are examining how psychological stress affects the treatment outcomes and prognosis of patients with gastric cancer or gastroesophageal junction cancer. This observational cohort study includes patients who have been diagnosed with these cancers and who are receiving surgery, chemotherapy, or immune checkpoint inhibitors. The study aims to understand links between stress levels and therapy success or disease progression. Participants are assessed for psychological stress using the Patient Health Questionnaire-9 (PHQ-9) and Generalized Anxiety Disorder Assessment 7 (GAD-7). Those scoring 5 or higher on either questionnaire are classified as stressed. The study follows three cohorts based on treatment and disease stage: Cohort 1 includes patients undergoing surgery plus adjuvant chemotherapy; Cohort 2 consists of patients receiving preoperative chemotherapy and surgery; Cohort 3 involves patients with advanced disease not undergoing surgery but receiving other therapies. Throughout the study, researchers track outcomes such as disease-free survival over three years, pathologic complete response rate after one month, and progression-free survival over one year. Participants are monitored for stress symptoms and treatment response, with assessments conducted using questionnaires and clinical evaluations. The study includes patients aged 18 to 80 years with good performance status, and results will help clarify how stress impacts gastric cancer treatment and prognosis.
CONDITIONS
Official 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 with ECOG performance status 0 or 1
- Diagnosed primary adenocarcinoma of gastric cancer or gastroesophageal junction cancer confirmed by pathology
- Cohort 1: Stage II-III disease, having R0 gastrectomy with D2 lymphadenectomy, receiving adjuvant chemotherapy
- Cohort 2: Stage III-IV disease, scheduled for gastrectomy and preoperative chemotherapy
- Cohort 3: Stage IV disease, not eligible for gastrectomy, with at least one measurable lesion per RECIST 1.1
You will not qualify if you...
- History of prior chemotherapy, radiotherapy, immunotherapy, or targeted therapy (Cohort 1)
- Multiple primary tumors
- Serious other diseases including cardiovascular, respiratory, kidney, or liver disease, or poorly controlled hypertension, diabetes, or mental disorders
- Unable to undergo R0 resection and D2 lymph node dissection (Cohort 1)
- Patients with stage IV gastric cancer (Cohort 1)
- Unable to receive chemotherapy, radiotherapy, immunotherapy, or targeted therapy (Cohorts 2 and 3)
- Unable to undergo gastrectomy when required (Cohort 2)
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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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