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This study has established a multidisciplinary rehabilitation team to recruit patients who underwent radical D2 gastrectomy in multiple centers and divided them into a rehabilitation group and a control group. Intervention will be carried out every time the patients come to the hospital for adjuvant chemotherapy and review. The control group uses traditional intervention model, and the rehabilitation group uses combined exercise/nutrition/psychology rehabilitation intervention.
This study is expected to promote early recovery after gastric cancer surgery through multidisciplinary rehabilitation intervention, reduce the occurrence of complications, improve patients' tolerance to adjuvant chemotherapy, and improve patients' quality of life, and hope to improve the short-term and long-term outcomes of gastric cancer patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| The rehabilitation group | Experimental | Standard SOX/XELOX adjuvant chemotherapy plus multimodal rehabilitation care |
|
| The control group | No Intervention | Standard SOX/XELOX adjuvant chemotherapy without multimodal rehabilitation care |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Standard SOX/XELOX adjuvant chemotherapy plus multimodal rehabilitation | Drug | Motivational counseling to perform nutritional, psychological, and exercise inventions |
|
| Measure | Description | Time Frame |
|---|---|---|
| Adjuvant chemotherapy completion rate | Completion rate of 8 cycles of adjuvant chemotherapy | At the end of Cycle 8 (each cycle is 21 days) |
| Measure | Description | Time Frame |
|---|---|---|
| 3-year disease-free survival (DFS) | Proportion of subjects who have been free of disease recurrence within 3 years from randomization. | 3 year |
| Overall survival | Time from randomization to death |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jieer Jieer, Dr | Contact | 0571-88122062 | jieerying@aliyun.com |
| Name | Affiliation | Role |
|---|---|---|
| Jieer Jieer, Dr | Zhejiang Cancer Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zhejiang Cancer Hospital | Hangzhou | Zhejiang | 310022 | China |
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| ID | Term |
|---|---|
| D013274 | Stomach Neoplasms |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| 3 year |
| Emotional state | Measured by GAD-7 questionnaire | 2 year |
| Weight | Weight | through study completion, an average of 2 year |
| Adverse event | Adverse event were evaluated through CTCAE | At the end of Cycle 8 (each cycle is 21 days) |
| D004066 |
| Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |