PTQA: A New Paradigm of Transfusion Decision Support for Patients With MDS
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 62
- 试验地点
- 2
- 主要终点
- Number of Hospitalizations (for Both Transfusion Groups)
研究概览
简要总结
This research study is evaluating how to best tailor blood transfusion decisions to match the quality of life changes experienced by individual patients with MDS.
详细描述
Each patient with MDS reacts differently to blood transfusions; some will feel better after transfusion, while others may not. The main purpose of this survey study is to determine whether it is possible to use quality of life changes - as measured by a validated questionnaire - experienced by individual patients to help physicians and patients with MDS make decisions regarding future blood transfusions. This research is being done because the investigators hope to help doctors better understand the impact of blood transfusions on the quality of life of each patient.
The study uses a standardized MDS-specific quality of life questionnaire that participants will fill out before and after an upcoming transfusion. The investigators will compare the scores of these questionnaires and notify both the participant and provider if the participant has experienced any changes (positive or negative) in his/her quality of life before and after transfusion. The investigators' hope is that doctor-patient teams will use this quality of life information to determine whether the participant should continue receiving transfusions, decrease the frequency of transfusions, or stop receiving transfusions altogether if not needed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Health Services Research
- 盲法
- None
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 of age
- •Patients with MDS
- •Patients approaching an Hb of 8.5 g/dL during enrollment period OR
- •Patients with >1 transfusion scheduled during an 8-week period
- •Ability to read and understand English
排除标准
- •Age <18 years
- •Known CHF
- •Unstable Angina
- •Hb level below 7.5 g/dL or above 8.5 g/dL
- •No plan for future transfusion.
- •Patient enrollment will happen after patient has consented and scheduled their first/next transfusion.
- •Patient will not be enrolled if no future transfusions are scheduled.
结局指标
主要结局
Number of Hospitalizations (for Both Transfusion Groups)
时间窗: Two months
Assessed via medical record review at two months post index transfusion
Number of Participants With Receipt of Second Transfusion
时间窗: Two months
Assessed via medical record review at two months post index transfusion
Median Difference in Units pRBCs (for Those Transfusion-dependent)
时间窗: Two months
Assessed via medical record review at two months post index transfusion. We identified historical matches for 25 patients (21 from Dana-Farber, 1 from Wake Forest, and 3 from Yale) and compared the median number of red cell units in these patients to the PTQA group over 2 months.
Number of Clinic Visits (for Both Transfusion Groups)
时间窗: Two months
Assessed via medical record review at two months post index transfusion
次要结局
- Perceptions of Impact of PTQA on Care(Two months)
- Perceived Stress by the Associated Scales(Two months)
- Number of Patients With Decisional Regret(Two months)
- PTQA Utilization(Two months)
研究者
Gregory A. Abel, MD
Principal Investigator
Dana-Farber Cancer Institute