S1316, Surgery or Non-Surgical Management in Treating Patients With Intra-Abdominal Cancer and Bowel Obstruction

Not Applicable

Completed

Conditions: Constipation, Impaction, and Bowel Obstruction
Unspecified Adult Solid Tumor, Protocol Specific

Brief Summary: This partially randomized clinical trial studies surgery or non-surgical management in treating patients with intra-abdominal cancer and bowel obstruction. Bowel obstruction is a common problem for advanced cancer patients and can negatively affect quality of life. It is not yet known whether surgery or non-surgical management is the best treatment option for bowel obstruction and can lead to better quality of life.

Detailed Description: This partially randomized clinical trial studies surgery or non-surgical management in treating patients with intra-abdominal cancer and bowel obstruction. Bowel obstruction is a common problem for advanced cancer patients and can negatively affect quality of life. It is not yet known whether surgery or non-surgical management is the best treatment option for bowel obstruction and can lead to better quality of life.

Recruitment & Eligibility

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Primary Outcome Measures

Name	Time	Method
Number of Days Alive and Outside of the Hospital	From date of registration up to 91 days	Number of days alive and outside of the hospital

Secondary Outcome Measures

Name	Time	Method
Ability to Eat	Assessed at 5 weeks post registration	Ability to consume food was assessed based on self or caregiver-reported 24-hour dietary recalls. Dietary recalls were collected by trained assessors at the University of Arizona Cancer Center Behavioral Measurement and Interventions Shared Resource (BMISR) via telephone using standardized protocols and Nutrient Database for Research.
Overall Survival	From date of registration to maximum of 53 weeks	Time from date of registration to date of death due to any cause.
MDASI-GI Symptom Assessment	Assessed at 4 weeks post registration	The MD Anderson Symptom Inventory for gastrointestinal cancer (MDASI-GI) was used to assess nausea, vomiting, pain, bloating, and constipation. The MDASI measures symptom severity on an 11-point scale, from 0 ("not present") to 10 ("as bad as you can imagine"). A difference of at least 1.2 points was considered a clinically meaningful difference between groups for MDASI-GI outcomes.
Days of NG Tube Use	During entire initial hospitalization (admission to discharge) to a maximum of 53 weeks post registration	Number of days a nasogastric tube was used during the patient's initial hospitalization
NG Tube Use	During initial hospitalization, from date of registration to a maximum of 53 weeks post registration	Use of a nasogastric tube
Number of Days in Hospital	During initial hospitalization, from date of registration to a maximum of 53 weeks post registration	Length of initial hospital stay in days.

Locations (38): Cancer Center at Saint Joseph's
🇺🇸
Phoenix, Arizona, United States
Banner University Medical Center - Tucson
🇺🇸
Tucson, Arizona, United States
University of Arkansas for Medical Sciences
🇺🇸
Little Rock, Arkansas, United States
City of Hope Comprehensive Cancer Center
🇺🇸
Duarte, California, United States
Loma Linda University Medical Center
🇺🇸
Loma Linda, California, United States
Moffitt Cancer Center
🇺🇸
Tampa, Florida, United States
Rush University Medical Center
🇺🇸
Chicago, Illinois, United States
University of Kansas Cancer Center
🇺🇸
Kansas City, Kansas, United States
UMass Memorial Medical Center - University Campus
🇺🇸
Worcester, Massachusetts, United States
University of Michigan Comprehensive Cancer Center
🇺🇸
Ann Arbor, Michigan, United States
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Cancer Center at Saint Joseph's
🇺🇸Phoenix, Arizona, United States