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

This study is currently recruiting participants.

Verified by M.D. Anderson Cancer Center, February 2009

First Received: February 23, 2009 No Changes Posted

Sponsored by:	M.D. Anderson Cancer Center
Information provided by:	M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:	NCT00849979

Purpose

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.
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.

Condition	Intervention
Gastrointestinal Cancer	Behavioral: Questionnaire Other: Interview

Study Type:	Interventional
Study Design:	Screening, Open Label, Single Group Assignment
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:

MedlinePlus related topics: Cancer

U.S. FDA Resources

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

Primary Outcome Measures:

To learn more about the symptoms that may occur in patients with GI cancer. [ Time Frame: 2 Years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To test a newly-designed questionnaire called the M. D. Anderson Symptom Inventory - Gastrointestinal (MDASI-GI) questionnaire. [ Time Frame: 2 Years ] [ Designated as safety issue: No ]

Estimated Enrollment:	185
Study Start Date:	July 2008
Estimated Primary Completion Date:	July 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1 Questionnaire	Behavioral: Questionnaire Day 1 MDASI-GI Questionnaire
2 Questionnaire + Interview	Behavioral: Questionnaire Day 1 MDASI-GI Questionnaire Other: Interview Open-ended, audiotaped interviews

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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

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

Contacts

Contact: Xin Shelley Wang, MD, MPH	713-745-3504
Contact: Marilyn Morrissey, MPH	713-745-3590

Locations

United States, Texas
UT MD Anderson Cancer Center	Recruiting
Houston, Texas, United States, 77030
Contact: Marilyn Morrissey
Principal Investigator: Xin Shelley Wang, MD, MPH

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:

MD Anderson Cancer Center website This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	UT MD Anderson Cancer Center ( Xin Shelley Wang, MD MPH/Assoc Professor )
Study ID Numbers:	2007-0228
Study First Received:	February 23, 2009
Last Updated:	February 23, 2009
ClinicalTrials.gov Identifier:	NCT00849979 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by M.D. Anderson Cancer Center:

Colorectal
Gastric
Gastrointestinal
GI
Liver
Pancreas

Gastrointestinal Cancers
GI
Gastro-Intestinal Chemotherapy
M.D. Anderson Symptom Inventory
MDASI-GI
Medical Oncology

Study placed in the following topic categories:

Digestive System Diseases
Digestive System Neoplasms
Gastrointestinal Diseases
Gastrointestinal Neoplasms
Pancrelipase

Additional relevant MeSH terms:

Neoplasms
Digestive System Diseases
Neoplasms by Site

Digestive System Neoplasms
Gastrointestinal Diseases
Gastrointestinal Neoplasms

ClinicalTrials.gov processed this record on August 30, 2009