Validating M.D. Anderson Symptom Inventory (MDASI-GI) in GI Cancer Patients Under Chemotherapy
This study has been completed.
Sponsor:
M.D. Anderson Cancer Center
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
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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
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 May 19, 2013