RecruitingNCT06786169

The Relationship of Psychological Stress With Therapy Efficacy and Prognosis of Gastric Cancer

Cohort Studies of Associations of Psychological Stress With Therapy Efficacy and Prognosis of Gastric Cancer (G-STRESS)

Sponsor

Fudan University

Enrollment

600 participants

Start Date

Sep 5, 2024

Study Type

OBSERVATIONAL

Conditions

Gastric Cancer, Gastroesophageal Junction Cancer

Summary

This is the prospective, observational cohort study (G-Distress) to explore the associations of psychological stress with treatment and prognosis of gastric cancer. The participants including the patients diagnosed with gastric cancer who received surgery, chemotherapy and immune checkpoint inhibitors.

Eligibility

Min Age: 18 YearsMax Age: 80 Years

Inclusion Criteria13

Cohort 1
Lower age limit of research subjects 18 years old and upper age limit of 80 years old, ECOG (ECOG score standard) performance status of 0 or 1
Be proven to be primary adenocarcinoma of gastric cancer and staged II-III by pathological evidences
R0 gastrectomy with D2 lymphadenectomy
Receiving adjuvant chemotherapy
Lower age limit of research subjects 18 years old and upper age limit of 80 years old, ECOG (ECOG score standard) performance status of 0 or 1
Be proven to be primary adenocarcinoma of gastric cancer and staged III-IV by pathological evidences
Receiving gastrectomy
Receiving preoperative chemotherapy
Lower age limit of research subjects 18 years old and upper age limit of 80 years old, ECOG (ECOG score standard) performance status of 0 or 1
Be proven to be primary adenocarcinoma of gastric cancer and staged IV by pathological evidences
Unavailable for gastrectomy
Presence of at least one measurable lesion according to the Response Evaluation Criteria in Solid Tumors version 1.1

Exclusion Criteria14

History of chemotherapy, radiotherapy, immunotherapy or target therapy
Multiple primary tumors
Suffering from other serious diseases, including cardiovascular, respiratory, kidney, or liver disease, complicated by poorly controlled hypertension, diabetes, mental disorders or diseases
Unavailable for R0 resection and D2 lymph node dissection.
Patients with stage IV gastric cancer
Cohort 2
Unavailable for chemotherapy, radiotherapy, immunotherapy or target therapy
Multiple primary tumors
Suffering from other serious diseases, including cardiovascular, respiratory, kidney, or liver disease, complicated by poorly controlled hypertension, diabetes, mental disorders or diseases
Unavailable for gastrectomy
Cohort 2
Unavailable for chemotherapy, radiotherapy, immunotherapy or target therapy
Multiple primary tumors
Suffering from other serious diseases, including cardiovascular, respiratory, kidney, or liver disease, complicated by poorly controlled hypertension, diabetes, mental disorders or diseases

Interventions

OTHERpsychological stress status

The assessment of depressive and anxiety symptoms was conducted using Patient Health Questionnaire-9 (PHQ-9) and Generalized Anxiety Disorder Assessment 7 (GAD-7). Patients with a PHQ-9 score ≥ 5 or a GAD-7 score ≥ 5 were categorized as the stressed group.