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Study Summary
No. BS99-094:.......Other Studies......Charles Cleeland......Symptom Research
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Study Summary Title
Study Summary
Number:
BS99-094
Study Title:Measuring the Symptom Distress of Cancer Patients: Development of a New Assessment System
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Physician New Patient Referral
Name:Charles CleelandPatients Call:800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)
Dept:Symptom ResearchReferring MD
Call:
800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)
Phone:713-74503470
Contact us about clinical trials
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General Information
Disease Group:Other StudiesSupported By:N/A
Phase of Study:N/AReturn
Visit:
N/A This is not a treatment protocol.
Treatment
Agents:
NoneHome Care:N/A This is not a treatment protocol.
Treatment Loc:Independent Multicenter Arrangements
Estimated
Length of Stay
in Houston:
N/A This is not a treatment protocol.
Description/
Intervention:
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.
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Study Objectives / Outcomes
1) To examine how the M.D. Anderson Inventory (MDASI) performs in various sample populations including community dwelling adults and patients who have different cancer types, who have undergone various treatments, and who have different and/or more severe symptoms.

2) To evaluate the MDASI as an estimate of functional status and quality of life.

3) To assess the impact of symptom severity on standard function and health-related quality of life measures, including both quantitative and qualitative measures (patient interviews).

4) To assess the pattern and severity of symptoms over multiple time points in order to assay the system's responsiveness to changes due to therapy or disease.

5) To explore the utility of an Interactive Voice Response (IVR) system in enhancing the clinical care of outpatients.

6) To explore the effect of information from an IVR symptom assessment system on a) the pattern of care and b) development of interdisciplinary protocols.

7) To explore the feasibility of developing symptom management pathways for patients based on these symptom and quality of life data.
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Study Status Information
Study Activation / Registration Date:04/13/1999
IRB Review and Approval Date:11/18/2005
Study Type:Other
Recruitment Status:Open
Projected Accrual:1,950 participants
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Enrollment Eligibility
If you do not meet the enrollment eligibility, there may be other treatment options for you. Please Contact the Referral Office for more information.

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. Diagnosis of cancer confirmed by pathology.

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

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Links
Registration Number: NCT00505245
Study Information on Clinical Trials Registry (clinicaltrials.gov)

Other Links:
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Results


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