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 are 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 MB patients.

Public Health Relevance

The ultimate goal of this research is to identify the optimal management strategy for malignant bowel obstruction. In many cases an initial surgical approach is chosen despite the lack of convincing clinical data that such an approach improves outcomes compared with best medical management. Alternatively, in many cases initial medical therapy fails leading to longer hospitalizations and poor health-related quality of life (HRQOL). This research could not only improve clinical management but likely improve cost-effectiveness or even reduce absolute expenditures. Our aims follow the National Cancer Institute's strategic objective to improve the quality of life for cancer patients, as well as the Institute of Medicine'report, Approaching Death: Improving Care at the End of Life, which urges the US research establishment to define and implement priorities for strengthening the knowledge base for end-of-life care including defining optimal treatment of symptoms near the end of life.

Agency
National Institute of Health (NIH)
Institute
Agency for Healthcare Research and Quality (AHRQ)
Type
Research Project (R01)
Project #
5R01HS021491-02
Application #
8740526
Study Section
Health Care Quality and Effectiveness Research (HQER)
Program Officer
Lawrence, William
Project Start
2013-09-30
Project End
2018-09-29
Budget Start
2014-09-30
Budget End
2015-09-29
Support Year
2
Fiscal Year
2014
Total Cost
Indirect Cost
Name
University of Arizona
Department
Internal Medicine/Medicine
Type
Schools of Medicine
DUNS #
806345617
City
Tucson
State
AZ
Country
United States
Zip Code
85721