Early Recovery After Surgery Protocol in Improving Quality of Life in Participants With Stage 0-IIIC Gastric Cancer Undergoing Surgery

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Gastric Cancer Enhanced Recovery After Surgery Pathway

Conditions
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Clinical Stage 0 Gastric Cancer AJCC v8, Clinical Stage I Gastric Cancer AJCC v8, Clinical Stage II Gastric Cancer AJCC v8, Clinical Stage IIA Gastric Cancer AJCC v8, Clinical Stage IIB Gastric Cancer AJCC v8, Clinical Stage III Gastric Cancer AJCC v8, Gastric Adenocarcinoma, Pathologic Stage 0 Gastric Cancer AJCC v8, Pathologic Stage I Gastric Cancer AJCC v8, Pathologic Stage IA Gastric Cancer AJCC v8, Pathologic Stage IB Gastric Cancer AJCC v8, Pathologic Stage II Gastric Cancer AJCC v8, Pathologic Stage IIA Gastric Cancer AJCC v8, Pathologic Stage IIB Gastric Cancer AJCC v8, Pathologic Stage III Gastric Cancer AJCC v8, Pathologic Stage IIIA Gastric Cancer AJCC v8, Pathologic Stage IIIB Gastric Cancer AJCC v8, Pathologic Stage IIIC Gastric Cancer AJCC v8

Intervention / Treatment
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* Other: Best Practice
* Other: Quality-of-Life Assessment
* Other: Questionnaire Administration


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients to be included are those with a biopsy proven diagnosis of gastric adenocarcinoma who are undergoing curative gastric surgery or prophylactic total gastrectomy for genetic risk. Patients with clinical stage 0-IIIC will be included. Any performance status and any life expectancy. The effects of gastric surgery on the developing fetus are unknown. For this reason, women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control or abstinence) prior to study entry and for six months following duration of study participation. Should a woman become pregnant or suspect that she is pregnant while participating on the trial, she should inform her treating physician immediately. All subjects must have the ability to understand and the willingness to sign a written informed consent. Prior therapy will not be used as a limitation in this study. Exclusion Criteria: Patients will be excluded if they are not candidates for surgery Patients will be excluded from the study if they have had prior gastric surgery, with the exception of a gastrostomy tube. Subjects, who in the opinion of the investigator, may not be able to comply with the safety monitoring requirements of the study.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Observational (ERAS protocol)<br>Participants complete standard of care early recovery after surgery protocol beginning the day before surgery to day 6 after surgery. | Other: Best Practice<br>* Complete standard of care enhanced recovery after surgery protocol<br>* Other names: standard therapy;Other: Quality-of-Life Assessment<br>* Ancillary studies<br>* Other names: Quality of Life Assessment;Other: Questionnaire Administration<br>* Ancillary studies<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 |