Clinical trial · Observational
M. D. Anderson Symptom Inventory - Heart Failure (MDASI-HF) Symptom Management Program
MDASI-HF: Bridging the Symptom Management Gap in Patients With Cancer and Concurrent Heart Failure to Improve Outcomes
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
| Heart Failure | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| MDASI-HF Questionnaire | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Group 1
- description
- MDASI-HF questionnaire provided to Doctor for symptom management.
- interventionNames
- Behavioral: MDASI-HF Questionnaire
- label
- Group 2
- description
- MDASI-HF questionnaire collected not provided to Doctor.
- interventionNames
- Behavioral: MDASI-HF Questionnaire
Primary outcomes (1)
- measure
- Mean Symptom Severity Scores (MDASI-HF Symptom Assessment Scores)
- timeFrame
- Baseline and at end of 3 Months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available