Validating M.D. Anderson Symptom Inventory (MDASI-GI) in GI Cancer Patients Under Chemotherapy
Primary Purpose
Gastrointestinal Cancer
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Questionnaire
Interview
Sponsored by
About this trial
This is an interventional screening trial for Gastrointestinal Cancer focused on measuring Colorectal, Gastric, Gastrointestinal, GI, Liver, Pancreas, Gastrointestinal Cancers, Gastro-Intestinal Chemotherapy, M.D. Anderson Symptom Inventory, MDASI-GI, Medical Oncology
Eligibility 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.
Sites / Locations
- UT MD Anderson Cancer Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
Questionnaire
Questionnaire + Interview
Arm Description
Outcomes
Primary Outcome Measures
Validation of M. D. Anderson Symptom Inventory - Gastrointestinal (MDASI-GI) Questionnaire (Response)
Secondary Outcome Measures
Full Information
NCT ID
NCT00849979
First Posted
February 23, 2009
Last Updated
July 26, 2012
Sponsor
M.D. Anderson Cancer Center
1. Study Identification
Unique Protocol Identification Number
NCT00849979
Brief Title
Validating M.D. Anderson Symptom Inventory (MDASI-GI) in GI Cancer Patients Under Chemotherapy
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 Type
Interventional
2. Study Status
Record Verification Date
July 2012
Overall Recruitment Status
Completed
Study Start Date
July 2008 (undefined)
Primary Completion Date
January 2010 (Actual)
Study Completion Date
January 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
M.D. Anderson Cancer Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
Detailed Description
Questionnaires:
If you agree to take part in this study, you will be asked to complete the MDASI-GI questionnaire on Day 1. It asks about any symptoms you may be experiencing, and how those symptoms may be interfering with your daily life. You will also complete two questionnaires that ask about the overall quality of your life. In total, these questionnaires should take about 20 minutes to complete.
You will then complete a questionnaire that asks for demographic information such as your age and marital status. It should take about 5 minutes.
You will receive another copy of the MDAS-GI questionnaire and the quality-of-life questionnaire to take home and complete 1 week later. The research staff will call you to remind you when it is time to complete this questionnaires. You should mail it back to the study staff in a stamped, pre-addressed envelope that will be provided to you.
Evaluation of Questionnaires:
Also on Day 1, a small group of participants (25 out of the 185 total participants) will complete an additional questionnaire called a "cognitive debriefing" questionnaire. These 25 participants will be the first 5 participants to join this study who have 1 of the 5 types of cancer being studied.
The questionnaire asks questions related to how easy it was for you to answer the questions on the MDASI-GI questionnaire, whether the questions relate to the symptoms you may be experiencing, and whether any other questions should be added. This questionnaire should take about 10 minutes to complete.
Interview:
Another small group of participants (a different 25 out of the 185 total) will have a one-on-one interview with a member of the study staff. During the interview, you will be asked to further describe the symptoms you may have experienced. This interview will be scheduled for a day when you are going to be at M. D. Anderson for a routine clinic visit. It should take about 30 minutes to complete.
You and the interviewer will be the only ones in the room during the interview, and the information collected will be kept confidential. The interview will be tape-recorded.
Questionnaire and Interview Content:
Your responses will not be shared with your doctor. If you feel you need a doctor's opinion about anything that is asked about, please contact your doctor.
Information Collection:
As part of this research study, the research staff will collect information from your medical record one time. This will include data about the cancer, cancer treatment, and routine test results.
Length of Study Participation:
After you mail back the questionnaire at Week 1 (or complete it by phone interview with research staff), or after the interview if you have one, your active participation in this study will be over.
This is an investigational study. Up to 185 patients will take part in this study. All will be enrolled at M. D. Anderson.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastrointestinal Cancer
Keywords
Colorectal, Gastric, Gastrointestinal, GI, Liver, Pancreas, Gastrointestinal Cancers, Gastro-Intestinal Chemotherapy, M.D. Anderson Symptom Inventory, MDASI-GI, Medical Oncology
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
184 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Questionnaire
Arm Type
Other
Arm Title
Questionnaire + Interview
Arm Type
Other
Intervention Type
Behavioral
Intervention Name(s)
Questionnaire
Intervention Description
Day 1 MDASI-GI Questionnaire
Intervention Type
Other
Intervention Name(s)
Interview
Intervention Description
Open-ended, audiotaped interviews
Primary Outcome Measure Information:
Title
Validation of M. D. Anderson Symptom Inventory - Gastrointestinal (MDASI-GI) Questionnaire (Response)
Time Frame
2 Years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xin Shelley Wang, MD, MPH
Organizational Affiliation
UT MD Anderson Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
UT MD Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
12. IPD Sharing Statement
Links:
URL
http://www.mdanderson.org
Description
MD Anderson Cancer Center website
Learn more about this trial
Validating M.D. Anderson Symptom Inventory (MDASI-GI) in GI Cancer Patients Under Chemotherapy
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