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

This study is currently recruiting participants.
Verified July 2017 by M.D. Anderson Cancer Center
Sponsor:
ClinicalTrials.gov Identifier:
NCT00505245
First Posted: July 23, 2007
Last Update Posted: July 7, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborators:
Bristol-Myers Squibb
Genentech, Inc.
Bayer
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
  Purpose
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

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 ]

Secondary Outcome Measures:
  • QOL Patient Survey Responses [ Time Frame: Survey completed at single point in time, estimated 20 minutes to complete ]

Estimated Enrollment: 4500
Actual Study Start Date: April 1999
Estimated Study Completion Date: April 2019
Estimated Primary Completion Date: April 2019 (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 may be asked to provide 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 one or more symptom surveys. Completing these surveys takes 10-25 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 a secure electronic method, 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 study staff 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 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 4,500 participants will participate in this multicenter study. Up to 4,000 will be enrolled at MD Anderson. Up to 500 will be enrolled at the Harris Health System.

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Individuals, over 18 years of age, diagnosed with an advanced cancer.
Criteria

Inclusion Criteria:

  1. Normal Samples: Community dwelling adults 18 years of age or older.
  2. Patient Samples: Inpatients and outpatients 18 years of age or older, being followed at UT MD Anderson or a collaborating site.
  3. Expert Panel Professional Participants: Physician or other healthcare provider with at least 5 years of experience caring for patients with the disease and/or treatment of interest, at least one publication in the last 5 years dealing with the disease and/or treatment of interest (physician only), ability to speak and read English, consent to participate.
  4. Expert Panel Family Caregiver Participants: Identification as a family caregiver by patient enrolled as expert panel participant with the disease and/or treatment of interest, 18 years of age or older, ability to speak and read English, consent to participate.
  5. Expert Panel Patient Participants: Patient with identified family caregiver participating on Expert Panel, willingness to receive packet for expert panel participation.

Exclusion Criteria:

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

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00505245


Contacts
Contact: Loretta A. Williams, PHD, MSN 713-745-3470

Locations
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
Genentech, Inc.
Bayer
Merck Sharp & Dohme Corp.
Investigators
Principal Investigator: Loretta A. Williams, PHD, MSN M.D. Anderson Cancer Center
  More Information

Additional Information:
Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00505245     History of Changes
Other Study ID Numbers: BS99-094
First Submitted: July 19, 2007
First Posted: July 23, 2007
Last Update Posted: July 7, 2017
Last Verified: July 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

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