S1316, Surgery or Non-Surgical Management in Treating Patients With Intra-Abdominal Cancer and Bowel Obstruction
- Conditions
- Constipation, Impaction, and Bowel ObstructionUnspecified Adult Solid Tumor, Protocol Specific
- Interventions
- Procedure: therapeutic conventional surgeryProcedure: gastrointestinal complications management/preventionOther: quality-of-life assessment
- Registration Number
- NCT02270450
- Lead Sponsor
- SWOG Cancer Research Network
- 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
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 221
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm III (no randomization, surgery) quality-of-life assessment Patients undergo therapeutic conventional surgery (abdominal) as defined by the treating physician as in Arm I. Arm I (randomized to surgery) therapeutic conventional surgery Patients undergo therapeutic conventional surgery (abdominal) as defined by the treating physician. Arm II (randomized to non-surgical management) gastrointestinal complications management/prevention Patients are offered gastrointestinal complications management/prevention (non-surgical management) as determined by the treating physician. Arm IV (no randomization, non-surgical management) gastrointestinal complications management/prevention Patients are offered gastrointestinal complications management/prevention (non-surgical management) as determined by the treating physician as in Arm II. Arm IV (no randomization, non-surgical management) quality-of-life assessment Patients are offered gastrointestinal complications management/prevention (non-surgical management) as determined by the treating physician as in Arm II. Arm I (randomized to surgery) quality-of-life assessment Patients undergo therapeutic conventional surgery (abdominal) as defined by the treating physician. Arm II (randomized to non-surgical management) quality-of-life assessment Patients are offered gastrointestinal complications management/prevention (non-surgical management) as determined by the treating physician. Arm III (no randomization, surgery) therapeutic conventional surgery Patients undergo therapeutic conventional surgery (abdominal) as defined by the treating physician as in Arm I.
- 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.
NG Tube Use During initial hospitalization, from date of registration to a maximum of 53 weeks post registration Use of a nasogastric tube
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
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.
Trial Locations
- Locations (38)
M D Anderson Cancer Center
🇺🇸Houston, Texas, United States
NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center
🇺🇸New York, New York, United States
Long Island Jewish Medical Center
🇺🇸New Hyde Park, New York, United States
University of Pennsylvania/Abramson Cancer Center
🇺🇸Philadelphia, Pennsylvania, United States
Temple University Hospital
🇺🇸Philadelphia, Pennsylvania, United States
Valley Health / Winchester Medical Center
🇺🇸Winchester, Virginia, United States
University of Kansas Cancer Center
🇺🇸Kansas City, Kansas, United States
Essentia Health Cancer Center
🇺🇸Duluth, Minnesota, United States
University Health Network-Princess Margaret Hospital
🇨🇦Toronto, Ontario, Canada
Methodist Hospital
🇺🇸Memphis, Tennessee, 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
Rush University Medical Center
🇺🇸Chicago, Illinois, United States
Loma Linda University Medical Center
🇺🇸Loma Linda, California, United States
UMass Memorial Medical Center - University Campus
🇺🇸Worcester, Massachusetts, United States
University of New Mexico Cancer Center
🇺🇸Albuquerque, New Mexico, United States
South Shore University Hospital
🇺🇸Bay Shore, New York, United States
North Shore University Hospital
🇺🇸Manhasset, New York, United States
Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center
🇺🇸Houston, Texas, United States
Methodist Le Bonheur Germantown Hospital
🇺🇸Germantown, Tennessee, United States
Instituto Nacional de Enfermedades Neoplasicas
🇵🇪Lima, Peru
Instituto Nacional De Cancerologia de Mexico
🇲🇽Mexico City, Tlalpan, Mexico
Cancer Center at Saint Joseph's
🇺🇸Phoenix, Arizona, United States
Moffitt Cancer Center
🇺🇸Tampa, Florida, United States
Duke University Medical Center
🇺🇸Durham, North Carolina, United States
University of Oklahoma Health Sciences Center
🇺🇸Oklahoma City, Oklahoma, United States
University Hospital
🇺🇸San Antonio, Texas, United States
University of Texas Health Science Center at San Antonio
🇺🇸San Antonio, Texas, United States
Medical College of Wisconsin
🇺🇸Milwaukee, Wisconsin, United States
Hackensack University Medical Center
🇺🇸Hackensack, New Jersey, United States
University of Michigan Comprehensive Cancer Center
🇺🇸Ann Arbor, Michigan, United States
Baylor University Medical Center
🇺🇸Dallas, Texas, United States
The West Clinic - Wolf River
🇺🇸Germantown, Tennessee, United States
Instituto Nacional De Cancerologia
🇨🇴Bogota, Colombia
Medical University of South Carolina
🇺🇸Charleston, South Carolina, United States
University of Tennessee Health Science Center
🇺🇸Memphis, Tennessee, United States
Rhode Island Hospital
🇺🇸Providence, Rhode Island, United States