MDASI-HF: Bridging the Symptom Management Gap in Patients With Cancer and Concurrent Heart Failure to Improve Outcomes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 26
- 试验地点
- 1
- 主要终点
- Mean Symptom Severity Scores (MDASI-HF Symptom Assessment Scores)
研究概览
简要总结
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:
- 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.
- Define symptom severity critical values in cancer patients with concurrent heart failure that trigger clinical intervention
- Identify symptom clusters which may occur in cancer patients with concurrent heart failure.
详细描述
Background for Study:
Heart failure means that the heart isn't pumping as well as it should be. Your body depends on the heart's pumping action to deliver oxygen- and nutrient-rich blood to the body's cells. When the cells are nourished properly, the body can function normally. With heart failure, the weakened heart can't supply the cells with enough blood. This results in fatigue and shortness of breath. Everyday activities such as walking, climbing stairs, or carrying groceries can become very difficult.
In the standard of care, patients tell their healthcare staff about their symptoms and are treated accordingly. The MDASI-HF program is a tool that is designed to try to improve this process by measuring how severe symptoms may be in patients with cancer and heart failure, as well as measuring how these symptoms may be affecting these patients' daily lives.
To take part in the MDASI-HF program, patients complete a questionnaire at clinic visits and at home. The home questionnaire is done over the phone. The symptom information that the patients report is provided to the healthcare staff, allowing the healthcare staff to closely monitor the symptoms and respond as needed.
You must have permission from your cardiologist in order to take part in this study.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
结局指标
主要结局
Mean Symptom Severity Scores (MDASI-HF Symptom Assessment Scores)
时间窗: Baseline and at end of 3 Months
次要结局
未报告次要终点