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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00849979
First received: February 23, 2009
Last updated: July 26, 2012
Last verified: July 2012
  Purpose

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 Intervention
Gastrointestinal Cancer
Behavioral: Questionnaire
Other: Interview

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • Validation of M. D. Anderson Symptom Inventory - Gastrointestinal (MDASI-GI) Questionnaire (Response) [ Time Frame: 2 Years ] [ Designated as safety issue: No ]

Enrollment: 184
Study Start Date: July 2008
Study Completion Date: January 2010
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Questionnaire Behavioral: Questionnaire
Day 1 MDASI-GI Questionnaire
Questionnaire + Interview Behavioral: Questionnaire
Day 1 MDASI-GI Questionnaire
Other: Interview
Open-ended, audiotaped interviews

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00849979

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

Additional Information:
No publications provided

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00849979     History of Changes
Other Study ID Numbers: 2007-0228
Study First Received: February 23, 2009
Last Updated: July 26, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by M.D. Anderson Cancer Center:
Colorectal
Gastric
Gastrointestinal
GI
Liver
Pancreas
Gastrointestinal Cancers
Gastro-Intestinal Chemotherapy
M.D. Anderson Symptom Inventory
MDASI-GI
Medical Oncology

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

ClinicalTrials.gov processed this record on August 18, 2014