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Validating M.D. Anderson Symptom Inventory (MDASI-GI) in GI Cancer Patients Under Chemotherapy

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ClinicalTrials.gov Identifier: NCT00849979
Recruitment Status : Completed
First Posted : February 24, 2009
Last Update Posted : July 30, 2012
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Brief Summary:
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.

Condition or disease Intervention/treatment
Gastrointestinal Cancer Behavioral: Questionnaire Other: Interview

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 184 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: M.D. Anderson Symptom Inventory (MDASI-GI) Validation and Clinical Utility in Patients With Gastrointestinal Cancers Being Treated or Followed by GI Medical Oncology
Study Start Date : July 2008
Primary Completion Date : January 2010
Study Completion Date : January 2010

Arm Intervention/treatment
Questionnaire Behavioral: Questionnaire
Day 1 MDASI-GI Questionnaire
Questionnaire + Interview Behavioral: Questionnaire
Day 1 MDASI-GI Questionnaire
Other: Interview
Open-ended, audiotaped interviews

Primary Outcome Measures :
  1. Validation of M. D. Anderson Symptom Inventory - Gastrointestinal (MDASI-GI) Questionnaire (Response) [ Time Frame: 2 Years ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Patients must be out-patients being reviewed or treated in M. D. Anderson's Department of GI Medical Oncology.
  • Patients will have received a confirmed pathological diagnosis of GI cancer (gastric cancer, liver cancer, pancreatic cancer, colorectal cancer).
  • Patients will or will not be undergoing chemotherapy or treatment with other agents on the day of enrollment.
  • Patients must be > or = 18 years of age.
  • Patients must be able to speak and read English.

Exclusion Criteria:

  • Patients who, in research staff's estimation, cannot understand the intent of the study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00849979

United States, Texas
UT MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Principal Investigator: Xin Shelley Wang, MD, MPH UT MD Anderson Cancer Center

Additional Information:
Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00849979     History of Changes
Other Study ID Numbers: 2007-0228
First Posted: February 24, 2009    Key Record Dates
Last Update Posted: July 30, 2012
Last Verified: July 2012

Keywords provided by M.D. Anderson Cancer Center:
Gastrointestinal Cancers
Gastro-Intestinal Chemotherapy
M.D. Anderson Symptom Inventory
Medical Oncology

Additional relevant MeSH terms:
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases