Prospective Comparative Effectiveness Trial for Malignant Bowel Obstruction

Patients with advanced cancer face challenges affecting quality of life (QOL). As the National Cancer Policy
Board has identified, research addressing the needs of patients with incurable cancers is severely deficient
and effectiveness has rarely been displayed by prospective trials. Malignant bowel obstruction (MBO) is a
common problem for advanced cancer patients that involves considerable suffering. There are two major
treatment approaches for MBO: surgical management and medical management with specific classes of
medications. There is little evidence-based information to choose the optimal clinical care for most patients
with a MBO. Goals for these patients may include the ability to eat, relief of nausea, pain control, being at
home, and along with an increase in survival. Treatments may improve QOL outcomes in many, but there is no
consistent measure defining improvement. The aim of this study is to compare the current treatment algorithms
of surgical and non-surgical approaches to MBO in terms of minimizing days in hospital and improving QOL.
This will be a five-year multi-site prospective comparative effectiveness study of patients who are admitted to
the hospital with an MBO. We have devised a mixed-design study of a smaller randomized population and a
larger observational cohort to ensure validity of observational results while enabling adequate accrual. To
accomplish this goal we will need to accrue 180 patients (50 in randomized sub-study, 130 in observational
study). The preponderance of MBO patients will be accrued to be prospectively followed utilizing general
modeling strategy along with propensity score techniques to compare treatment approaches. In addition, we
will have a smaller subset of patients who will be randomized to surgical versus non-surgical interventions. Our
data collection strategies are designed to minimize patient burden by this alternate research approach with
clinically meaningful outcome measures as well as limited health-related quality of life surveys.
The primary inclusion criteria for the study is whether a surgical option is being considered in the setting of
MBO and there is equipoise to outcomes. The interventions to be compared are an initial surgical versus a
non-surgical approach for MBO. Data forms will include demographic and disease history, hospital stay, days
with NG tubes, TPN and other hydration, ability to eat or drink with dietary histories, complications, recurrence,
total hospital days, and survival. In addition, research coordinators will serially acquire subjective QOL data
from the MD Anderson Symptom Inventory - Gastrointestinal, which should not take more than 10 minutes to
complete. The primary outcome measure will be good days, defined as being at home (out of the hospital)
and alive. The difference we hope to find is two weeks in a 90 day span (20% difference). Secondary
endpoints include days with NG tube, days of intravenous hydration, days eating solid foods, days drinking,
and amount of intake, recurrence, morbidity, and survival. We will include a cost analysis plan as well. We
anticipate results to be clinically useful to practitioners caring for MBO patients.