M. D. Anderson Symptom Inventory - Heart Failure (MDASI-HF) Symptom Management Program
NCT00827801 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 26
Last updated 2012-07-23
Summary
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.
Conditions
Interventions
- BEHAVIORAL
-
MDASI-HF Questionnaire
M. D. Anderson Symptom Inventory - Heart Failure (MDASI-HF) questionnaire rating symptoms given in clinic Day 1, Weeks 4 \& 8.
Sponsors & Collaborators
-
M.D. Anderson Cancer Center
lead OTHER
Principal Investigators
-
Anecita Fadol, PhD, MS · UT MD Anderson Cancer Center
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2009-01-31
- Primary Completion
- 2011-08-31
- Completion
- 2011-08-31
Countries
- United States
Study Locations
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