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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2018-01639 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| 17482 | Other Identifier | City of Hope Comprehensive Cancer Center |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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This phase II trial studies how well an early recovery after surgery protocol works in enhancing quality of life in participants with stage 0-IIIC gastric cancer undergoing surgery. The early recovery after surgery protocol may decrease pain and nausea, promote bowl function, decrease the number of days hospitalized, and improve a participant's ability to function normally after surgery.
PRIMARY OBJECTIVES:
I. Determine how the enhanced recovery after surgery (ERAS) protocol affects patient?s length of hospital stay after radical gastrectomy.
II. Determine the association between ambulation (number of steps taken) while hospitalized and complications.
III. Determine the association between pre-operatively and postoperatively drawn biochemical markers and complications, disease free survival, and overall survival.
OUTLINE:
Participants complete standard of care early recovery after surgery protocol beginning the day before surgery to day 6 after surgery.
After completion of study, participants are followed up at days 14, 30, 80-110, and 170-200, and at 11-14 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Observational (ERAS protocol) | Participants complete standard of care early recovery after surgery protocol beginning the day before surgery to day 6 after surgery. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Best Practice | Other | Complete standard of care enhanced recovery after surgery protocol |
|
| Measure | Description | Time Frame |
|---|---|---|
| Length of stay | Will determine the length of hospital stay after surgery | from date of surgery to discharge from hospital, assessed up to 30 days |
| Rate and type of post-operative complications | Up to 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Overall quality of life assessment | EORTC QLQ-C30 questionnaires to measure Quality of life | One time within 30 days of surgery, One time within 30 days after surgery, One time at 3 months after surgery, One time 6 months after surgery, One time 12 months after surgery |
| QoL after stomach cancer surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Ambulation | Number of steps taken after surgery as measured by a podometer | From time of surgery to first postoperative clinic visit, assessed up to 30 days |
| Immune biomarkers | Blood levels of hsCRP will be measured before and after surgery to determine its relationship to complications and recurrence |
Inclusion Criteria:
Exclusion Criteria:
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Patients with a biopsy proven diagnosis of gastric adenocarcinoma who are undergoing curative gastric surgery or prophylactic total gastrectomy for genetic risk
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| Name | Affiliation | Role |
|---|---|---|
| Yanghee Woo | City of Hope Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| City of Hope Medical Center | Duarte | California | 91010 | United States |
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| Quality-of-Life Assessment | Other | Ancillary studies |
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| Questionnaire Administration | Other | Ancillary studies |
|
STO22 questionnaires to measure stomach cancer surgery related QoL |
| One time within 30 days of surgery, One time within 30 days after surgery, One time at 3 months after surgery, One time 6 months after surgery, One time 12 months after surgery |
| one time 30 days within surgery, One time 1 day after surgery, One time 3 days after surgery, One time 30 days after surgery, One time 90 days after surgery, one time 6 months after surgery, One time 12 months after surgery |
| Disease free survival of enrolled patients | Up to 14 months after surgery |
| Overall survival of enrolled patients | Up to 14 months after surgery |
| ID | Term |
|---|---|
| D017410 | Practice Guidelines as Topic |
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D017408 | Guidelines as Topic |
| D011785 | Quality Assurance, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
| D019984 | Quality Indicators, Health Care |
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