The Relationship of Psychological Stress With Therapy Efficacy and Prognosis of Gastric Cancer
NCT ID: NCT06786169
Last Updated: 2025-01-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
600 participants
OBSERVATIONAL
2024-09-05
2029-09-15
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Cohort 1: advanced gastric cancer patients receiving surgery
psychological 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.
Cohort 2: stage III-IV gastric cancer patients receiving preoperative treatment
psychological 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.
Cohort 3: stage IV gastric cancer patients receiving chemotherapy, immunotherapy or ta
psychological 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.
Interventions
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psychological 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.
Eligibility Criteria
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Inclusion Criteria
2. Be proven to be primary adenocarcinoma of gastric cancer and staged II-III by pathological evidences
3. R0 gastrectomy with D2 lymphadenectomy
4. Receiving adjuvant chemotherapy
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
2. Be proven to be primary adenocarcinoma of gastric cancer and staged III-IV by pathological evidences
3. Receiving gastrectomy
4. Receiving preoperative chemotherapy
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
2. Be proven to be primary adenocarcinoma of gastric cancer and staged IV by pathological evidences
3. Unavailable for gastrectomy
4. Presence of at least one measurable lesion according to the Response Evaluation Criteria in Solid Tumors version 1.1
Exclusion Criteria
2. Multiple primary tumors
3. Suffering from other serious diseases, including cardiovascular, respiratory, kidney, or liver disease, complicated by poorly controlled hypertension, diabetes, mental disorders or diseases
4. Unavailable for R0 resection and D2 lymph node dissection.
5. Patients with stage IV gastric cancer
Cohort 2
1. Unavailable for chemotherapy, radiotherapy, immunotherapy or target therapy
2. Multiple primary tumors
3. Suffering from other serious diseases, including cardiovascular, respiratory, kidney, or liver disease, complicated by poorly controlled hypertension, diabetes, mental disorders or diseases
4. Unavailable for gastrectomy
Cohort 2
1. Unavailable for chemotherapy, radiotherapy, immunotherapy or target therapy
2. Multiple primary tumors
3. Suffering from other serious diseases, including cardiovascular, respiratory, kidney, or liver disease, complicated by poorly controlled hypertension, diabetes, mental disorders or diseases
18 Years
80 Years
ALL
No
Sponsors
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Fudan University
OTHER
Responsible Party
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Dazhi Xu
Professor
Locations
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Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China
Countries
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Central Contacts
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Other Identifiers
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G-STRESS
Identifier Type: -
Identifier Source: org_study_id
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