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

NCT00827801 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 26

Last updated 2012-07-23

No results posted yet for this study

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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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00827801 on ClinicalTrials.gov