Exploring how psychological stress affects treatment outcomes in gastric cancer
Cohort Studies of Associations of Psychological Stress With Therapy Efficacy and Prognosis of Gastric Cancer (G-STRESS)
This study is trying to see how psychological stress affects the treatment results for people with gastric cancer who have had surgery and other therapies.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 600 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Fudan University Academic / other |
| Drugs / interventions | chemotherapy, immunotherapy |
| Locations | 1 site (Shanghai, Shanghai Municipality) |
| Trial ID | NCT06786169 on ClinicalTrials.gov |
What this trial studies
This observational cohort study aims to investigate the relationship between psychological stress and the efficacy of treatments for gastric cancer. Participants will include patients diagnosed with primary adenocarcinoma of gastric cancer who have undergone surgery, chemotherapy, and immune checkpoint inhibitors. The study will assess the psychological stress status of these patients to determine its impact on their treatment outcomes and prognosis. By analyzing these associations, the study seeks to provide insights into how stress may influence recovery and survival rates in gastric cancer patients.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 80 with stage II-III primary adenocarcinoma of gastric cancer who have undergone R0 gastrectomy and are receiving adjuvant chemotherapy.
Not a fit: Patients with stage IV gastric cancer or those with a history of prior cancer treatments may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment strategies that consider psychological stress, potentially enhancing patient outcomes.
How similar studies have performed: While the relationship between psychological stress and cancer treatment outcomes has been explored in other studies, this specific focus on gastric cancer and its treatment efficacy is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Cohort 1 Inclusion Criteria: 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 II-III by pathological evidences 3. R0 gastrectomy with D2 lymphadenectomy 4. Receiving adjuvant chemotherapy Exclusion Criteria: 1. History of 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 R0 resection and D2 lymph node dissection. 5. Patients with stage IV gastric cancer Cohort 2 Inclusion Criteria: 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 Exclusion Criteria: 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 Inclusion Criteria: 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: 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
Where this trial is running
Shanghai, Shanghai Municipality
- Fudan University Shanghai Cancer Center — Shanghai, Shanghai Municipality, China (Recruiting)
Study contacts
- Study coordinator: Jing Guo, MD
- Email: gjsysu@126.com
- Phone: 86-02164175590
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.