M.D. Anderson Symptom Inventory (MDASI) Validation Study in Cancer Patients

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by M.D. Anderson Cancer Center
Bristol-Myers Squibb
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
First received: July 19, 2007
Last updated: September 12, 2014
Last verified: September 2014

The purpose of this study is to try to learn more about common symptoms that may occur in patients due to cancer and its treatment. We also want to learn more about the impact of symptoms on your quality of life. Another goal is to learn how to better measure symptoms systematically when caring for patients.

Condition Intervention
Advanced Cancer
Behavioral: Survey

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Measuring the Symptom Distress of Cancer Patients: Development of a New Assessment System

Resource links provided by NLM:

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

Primary Outcome Measures:
  • MDSAI Validity and Reliability <Patient Survey Responses> [ Time Frame: Survey completed at single point in time, estimated 20 minutes to complete ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • QOL Patient Survey Responses [ Time Frame: Survey completed at single point in time, estimated 20 minutes to complete ] [ Designated as safety issue: No ]

Estimated Enrollment: 2500
Study Start Date: April 1999
Estimated Primary Completion Date: April 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
MDASI Validation
Surveys taking about 20 minutes to complete; collected at multiple time points for some patient populations.
Behavioral: Survey
Surveys taking about 20 minutes to complete; collected at multiple time points for some patient populations.
Other Name: Questionnaire

Detailed Description:

You will be asked to complete a form with some personal information. You will also be asked to complete surveys that measure your mood and quality of life. You will be asked to complete the symptom survey (the MD Anderson Symptom Inventory) that will ask you to rate your symptoms and how much the symptoms interfere in your daily activities. Completing these surveys takes about 20 minutes.

In order to understand symptoms that are specific to a particular cancer, cancer stage, or treatment, the research staff may ask you questions about symptoms you have had since you were diagnosed. The interviewer may ask follow-up questions to get more complete information about your symptoms. Interviews are digitally recorded and then transcribed (written out in text) later. Completing the interview along with other surveys takes about 45 minutes total.

During your treatment, you may be asked to complete the symptom survey using the paper and pencil method, or an electronic tablet, or you may be asked to complete it over the telephone. If you are asked to use the phone method, we will use an interactive voice response (IVR) telephone system to contact you to find out about symptoms you may be experiencing. The research nurse will ask you for a convenient time for the system to call.

How often the system will call you during your treatment depends on the type of treatment you are receiving. The research study staff will give you more information about the schedule of calls to expect for the study and the times you will be asked to complete the mood and quality of life surveys over the course of your treatment.

Information about your symptoms collected in this study is collected for research purposes only. If you are experiencing severe or troublesome symptoms, you should report them to your doctor or nurse as well as rating them on the symptom assessment questionnaire. If the data collector notices that you have rated a symptom as severe, the data collector will ask you if your doctor or nurse is aware of the symptom or if you intend to report the symptom to your doctor or nurse. If you have not or do not intend to report the symptom, the data collector will let you know that he or she will report the symptom to your doctor or nurse.

This is an investigational study. Up to 3,000 participants will participate in this multicenter study. Up to 2,500 will be enrolled at MD Anderson. Up to 500 will be enrolled at the Harris Health System.


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Individuals, over 18 years of age, diagnosed with an advanced cancer.


Inclusion Criteria:

1) 1.) Normal Samples: Community dwelling adults > 18 years of age. 2.) Patient Samples: In patients and out patients > 18 years of age, being followed at UT M.D. Anderson or a collaborating site.

Exclusion Criteria:

1) Those who refuse to participate or are determined incapable of completing the research.

  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: NCT00505245

Contact: Charles Cleeland, PhD 713-745-3470

United States, Texas
University of Texas MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Principal Investigator: Charles Cleeland, PhD         
Sponsors and Collaborators
M.D. Anderson Cancer Center
Bristol-Myers Squibb
Principal Investigator: Charles Cleeland, PhD M.D. Anderson Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00505245     History of Changes
Other Study ID Numbers: BS99-094
Study First Received: July 19, 2007
Last Updated: September 12, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by M.D. Anderson Cancer Center:
Advanced Cancer
Symptom Distress
M.D. Anderson Symptom Inventory
Quality of Life
Interactive voice response telephone system

ClinicalTrials.gov processed this record on September 16, 2014