Early Recovery After Surgery Protocol in Improving Quality of Life in Participants With Stage 0-IIIC Gastric Cancer Undergoing Surgery
Study Details
Study Description
Brief Summary
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
PRIMARY OBJECTIVES:
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Determine how the enhanced recovery after surgery (ERAS) protocol affects patient?s length of hospital stay after radical gastrectomy.
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Determine the association between ambulation (number of steps taken) while hospitalized and complications.
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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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Observational (ERAS protocol) Participants complete standard of care early recovery after surgery protocol beginning the day before surgery to day 6 after surgery. |
Other: Best Practice
Complete standard of care enhanced recovery after surgery protocol
Other Names:
Other: Quality-of-Life Assessment
Ancillary studies
Other Names:
Other: Questionnaire Administration
Ancillary studies
|
Outcome Measures
Primary Outcome Measures
- Length of stay [from date of surgery to discharge from hospital, assessed up to 30 days]
Will determine the length of hospital stay after surgery
- Rate and type of post-operative complications [Up to 1 year]
Secondary Outcome Measures
- Overall quality of life assessment [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]
EORTC QLQ-C30 questionnaires to measure Quality of life
- QoL after stomach cancer surgery [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]
STO22 questionnaires to measure stomach cancer surgery related QoL
Other Outcome Measures
- Ambulation [From time of surgery to first postoperative clinic visit, assessed up to 30 days]
Number of steps taken after surgery as measured by a podometer
- Immune biomarkers [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]
Blood levels of hsCRP will be measured before and after surgery to determine its relationship to complications and recurrence
- Disease free survival of enrolled patients [Up to 14 months after surgery]
- Overall survival of enrolled patients [Up to 14 months after surgery]
Eligibility Criteria
Criteria
Inclusion Criteria:
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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.
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Patients with clinical stage 0-IIIC will be included.
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Any performance status and any life expectancy.
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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.
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All subjects must have the ability to understand and the willingness to sign a written informed consent.
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Prior therapy will not be used as a limitation in this study.
Exclusion Criteria:
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Patients will be excluded if they are not candidates for surgery
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Patients will be excluded from the study if they have had prior gastric surgery, with the exception of a gastrostomy tube.
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Subjects, who in the opinion of the investigator, may not be able to comply with the safety monitoring requirements of the study.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | City of Hope Medical Center | Duarte | California | United States | 91010 |
Sponsors and Collaborators
- City of Hope Medical Center
- National Cancer Institute (NCI)
Investigators
- Principal Investigator: Yanghee Woo, City of Hope Medical Center
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 17482
- NCI-2018-01639
- 17482