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Treatment Study for Patients with Intra-Abdominal Cancer and Bowel Obstruction
Malignant bowel obstruction (MBO) is a common problem for people with advanced cancer and it 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. Both of these options are commonly used, considered standard of care. The purpose of this study is to compare the quality of life of subjects with MBO who are treated with surgery to that of similar subjects who are treated with the best non-surgical treatment.
This study has two components: a randomized portion and a non-randomized portion. If eligible, subjects may join either component.
In the randomized part of this study, a computer will assign the participant to one of two treatment groups. Group 1 will receive the usual abdominal surgery for MBO which will involve an incision in the abdomen. Group 2 will receive the usual non-surgical treatment for MBO which includes intravenous hydration, often naso-gastric tube decompression, and medications to prevent pain or nausea. Subjects may also receive medications to decrease the swelling of the bowels.
If the participant or their doctor does not want to be randomly assigned to a treatment group, they may still participate in the non-randomized component of this study. The participant and their doctor will decide which treatment approach to use (surgical versus non-surgical treatment). The treatment will be recorded and the study team will follow the subject closely for health status and quality of life.
All of the study exams, tests, and procedures are part of the standard care for MBO. However, the study team will contact participants more often to track their health status and quality of life.
Participants will receive weekly telephone call (or hospital visits if in the hospital) for 13 weeks from the start of the study and then monthly telephone calls for up to 1 year. Each telephone call or hospital visit will last for about 15 minutes. These telephone calls will include questions about quality of life, recent hospitalizations, and MBO-related problems. Participants will receive monthly telephone calls from the Arizona Diet, Behavior, and Quality of Life Assessment Lab to find out what the subject is eating. Each of these telephone calls will last for about 15-20 minutes.
Participants will also have the option to allow a family member or caregiver to answer these calls and questions on their behalf.
In order to participate you must meet the following criteria:
- Have malignant bowel obstruction.
- Have a bowel obstruction due to an intra-abdominal primary cancer, not colorectal cancer.
- Are 18 years of age or older and are able to complete the study questionnaires.
You will be excluded from the study if any of the following criteria apply to you:
- Have signs of bowel perforation or “acute” abdomen.
- Have a bowel obstruction is due to colorectal cancer.
This is a partial list of inclusion and exclusion criteria.