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Study Summary
No. 2007-0228:.......Colorectal; Gastric; Gastrointestinal; Liver; Pancreas......Xin Shelley Wang......Symptom Research
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Study Summary Title
Study Summary
Number:		2007-0228
Study Title:MDASI-GI Validation and Clinical Utility in Patients with Gastrointestinal
Cancers being Treated or Followed by GI Medical Oncology
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Physician New Patient Referral
Name:Xin Shelley WangPatients Call:800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)
Dept:Symptom ResearchReferring MD
Call:		800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)
Phone:713-745-3504
Contact us about clinical trials
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General Information
Disease Group:Colorectal
Gastric
Gastrointestinal
Liver
Pancreas		Supported By:Pfizer
Phase of Study:N/AReturn
Visit:		No required return visit for this study; will follow-up patients 10 days later
by mail.
Treatment
Agents:		NoneHome Care:No
Treatment Loc:Only at MDACC
Estimated
Length of Stay
in Houston:		No required hospitalization.
Description/
Intervention:		The goal of this study is to learn more about the symptoms that may occur in
patients with GI cancer. The types of GI cancer being studied are cancers of
the stomach, liver, pancreas, colon, and rectum. Researchers want to test a
newly-designed questionnaire called the M. D. Anderson Symptom Inventory -
Gastrointestinal (MDASI-GI) questionnaire.
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Study Objectives / Outcomes
The goals of proposed study are:
1. To generate and psychometrically validate a Gastro-Intestinal Chemotherapy Module for M.D. Anderson Symptom Inventory (MDASI-GI for Medical Oncology) for clinical trials and patient care that is sensitive to a measure of symptom burden.

2. To provide the symptom profile and symptom burden data measured by the MDASI-GI in patients with gastrointestinal (GI) cancers under the care of medical oncology for use in future clinical trials.
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Study Status Information
Study Activation / Registration Date:06/23/2008
IRB Review and Approval Date:06/23/2008
Study Type:Behavioral
Recruitment Status:Terminated
Projected Accrual:N/A
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Enrollment Eligibility
If you do not meet the enrollment eligibility, there may be other treatment options for you. Please Contact the Referral Office for more information.
Inclusion Criteria:1) Patients must be out-patients being reviewed or treated in M. D. Anderson's Department of GI Medical Oncology.

2) Patients will have received a confirmed pathological diagnosis of GI cancer (gastric cancer, liver cancer, pancreatic cancer, colorectal cancer).

3) Patients will or will not be undergoing chemotherapy or treatment with other agents on the day of enrollment.

4) Patients must be > or = 18 years of age.

5) Patients must be able to speak and read English.
Exclusion Criteria:1) Patients who, in research staff's estimation, cannot understand the intent of the study.
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Links
Registration Number: NCT00849979
Study Information on Clinical Trials Registry (clinicaltrials.gov)
Other Links:
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Results

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