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Study Summary
No. 2007-0722:.......Psychosocial......Anecita Fadol......Cardiology
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Study Summary Title
Study Summary
Number:		2007-0722
Study Title:MDASI-HF: Bridging the Symptom Management Gap in Patients with Cancer and Concurrent Heart Failure to Improve Outcomes
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Physician New Patient Referral
Name:Anecita FadolPatients Call:800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)
Dept:CardiologyReferring MD
Call:		800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)
Phone:713-794-4197
Contact us about clinical trials
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General Information
Disease Group:PsychosocialSupported By:UT MDACC
Phase of Study:N/AReturn
Visit:		N/A
Treatment
Agents:		NoneHome Care:N/A
Treatment Loc:Only at MDACC
Estimated
Length of Stay
in Houston:		N/A
Description/
Intervention:		The goal of this research study is to compare a newly-designed symptom
management program with the standard of care for symptom management, in
patients with cancer and heart failure. The newly-designed program being
studied is called the M. D. Anderson Symptom Inventory - Heart Failure
(MDASI-HF) program. Researchers want to learn if the MDASI-HF tool can help
doctors in their decision-making when it comes to managing heart failure in
cancer patients.
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Study Objectives / Outcomes
Primary Objective:

To determine if there is a reduction in the mean symptom severity scores for the heart failure specific symptom items between baseline and at the end of three months between patients whose symptoms are managed using the MDASI-HF symptom assessment scores (treatment group) as a decision making guide, as compared to patients managed without using the MDASI-HF symptom assessment scores (control group).

Secondary Objectives:

The secondary objectives of the study are to:
1) examine the correlation between mean symptom severity scores and the secondary endpoints of: a) exercise tolerance ( 6-minute walk), b) NYHA (New York Heart Association) functional classification, c) B-type natriuretic peptide (a biomarker for heart failure), and d) dose titration of HF (heart failure) medications.
2) Define symptom severity critical values in cancer patients with concurrent heart failure that trigger clinical intervention
3) Identify symptom clusters which may occur in cancer patients with concurrent heart failure.
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Study Status Information
Study Activation / Registration Date:01/21/2009
IRB Review and Approval Date:08/04/2008
Study Type:Observational
Recruitment Status:Terminated
Projected Accrual:N/A
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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) All cancer patients with a concurrent diagnosis of heart failure. Heart failure can be systolic (<40% ejection fraction) or diastolic (>40% ejection fraction). Functioning at New York Heart Association class II, III, or IV.

2) Age 18 years and older

3) Able to give informed consent to participate

4) Working phone number to contact patient

5) Live within the 100 mile radius of the Houston area while enrolled in the study for the three month duration
Exclusion Criteria:1) Younger than 18 years old

2) With a known diagnosis of dementia or Alzheimer's disease

3) Not familiar with the English language. The MDASI-HF is currently available in the English language only.
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Links
Registration Number: NCT00827801
Study Information on Clinical Trials Registry (clinicaltrials.gov)
Other Links:
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Results

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