M. D. Anderson Symptom Inventory - Heart Failure (MDASI-HF) Symptom Management Program

Completed

Conditions studied: Heart Failure, Cancer

In brief

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: 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.

Key facts

Study ID

NCT00827801

Run by

M.D. Anderson Cancer Center

People needed

26

Starts

2009-01-01

Expected to finish

2011-08-01

Last updated by the study team

2012-07-23

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.
• Age 18 years and older
• Able to give informed consent to participate
• Working phone number to contact patient
• Live within the 100 mile radius of the Houston area while enrolled in the study for the three month duration

You may not qualify if…

• Younger than 18 years old
• With a known diagnosis of dementia or Alzheimer's disease
• Not familiar with the English language. The MDASI-HF is currently available in the English language only.

Where it is running

• UT MD Anderson Cancer Center — Houston, Texas, United States

Full record on ClinicalTrials.gov

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