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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

February 23, 2009
July 26, 2012
July 2008
January 2010   (final data collection date for primary outcome measure)
Validation of M. D. Anderson Symptom Inventory - Gastrointestinal (MDASI-GI) Questionnaire (Response) [ Time Frame: 2 Years ] [ Designated as safety issue: No ]
To learn more about the symptoms that may occur in patients with GI cancer. [ Time Frame: 2 Years ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00849979 on ClinicalTrials.gov Archive Site
Not Provided
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 ]
Not Provided
Not Provided
 
Validating M.D. Anderson Symptom Inventory (MDASI-GI) in GI Cancer Patients Under Chemotherapy
M.D. Anderson Symptom Inventory (MDASI-GI) Validation and Clinical Utility in Patients With Gastrointestinal Cancers Being Treated or Followed by GI Medical Oncology

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.

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.

Interventional
Not Provided
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Screening
Gastrointestinal Cancer
  • Behavioral: Questionnaire
    Day 1 MDASI-GI Questionnaire
  • Other: Interview
    Open-ended, audiotaped interviews
  • Questionnaire
    Intervention: Behavioral: Questionnaire
  • Questionnaire + Interview
    Interventions:
    • Behavioral: Questionnaire
    • Other: Interview
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
184
January 2010
January 2010   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00849979
2007-0228
No
M.D. Anderson Cancer Center
M.D. Anderson Cancer Center
Not Provided
Principal Investigator: Xin Shelley Wang, MD, MPH UT MD Anderson Cancer Center
M.D. Anderson Cancer Center
July 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP