Symptom Burden and Health Related Quality of Life of Cancer Patients With Concurrent Heart Failure
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 102
- 试验地点
- 1
- 主要终点
- Heart Failure
研究概览
简要总结
To describe and compare the symptom burden in cancer patients with concurrent diagnosis of heart failure (HFrEF compared to HFpEF).
详细描述
The investigators will conduct a symptom assessment at study enrollment on cancer participants with a concurrent diagnosis of HF (HFrEF and HFpEF) using the MD Anderson Symptom Inventory- Heart Failure (MDASI-HF) and PROMIS Instruments (Fatigue, Dyspnea, and Sleep Disturbance).
The investigators will also describe and compare the health-related quality of life using the European Organization for Research and Training Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) and the measure of Quality of Life Short Form-12 (SF-12).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 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
- •Age 18 years and older
- •Individuals with a concurrent solid tumor cancer diagnosis
- •Not receiving active cancer treatment except for those on maintenance (i.e., Selective ER modulators (SERMs)[Tamoxifen], Aromatase inhibitors (Anastrozole, Letrozole, Exemestane), Ovarian suppression therapy (GnRH Agonists [Leuprolide], Androgen deprivation therapy for prostate cancer
- •Completed cancer treatment at least 3 months and up to 3 years before study enrollment.
- •Able to read, speak and consent in English
- •Ability to understand and the willingness to sign a written informed consent document
- •Diagnosis of heart failure, confirmed by echocardiogram, MUGA, or cardiac catheterization
- •Internet access via smart phone, tablet, a computer, or another device with the capacity to 1) download the Fitbit App and 2) complete electronic study assessments via REDCap.
排除标准
- •Participants undergoing active cancer treatment.
- •Inability to provide consent in the medical record, such as cognitively impaired individuals.
研究组 & 干预措施
SingleArm
Symptom Assessment and Comparison
结局指标
主要结局
Heart Failure
时间窗: Through study completion, an average of 3 years
The investigators will conduct a symptom assessment at study enrollment on cancer participants with a concurrent diagnosis of HF (HFrEF and HFpEF) using the MD Anderson Symptom Inventory- Heart Failure (MDASI-HF) and PROMIS Instruments (Fatigue, Dyspnea, and Sleep Disturbance).
次要结局
未报告次要终点