FEASIBILITY OF IMPLEMENTING PRE-TRANSPLANT EVALUATION BY THE SUPPORTIVE CARE TEAM FOR PATIENTS UNDERGOING HEMATOPOIETIC CELL TRANSPLANTATION FOR HEMATOLOGICAL MALIGNANCIES
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Study participation rates defined as the proportion of patients who consent to enroll
研究概览
简要总结
This pilot clinical trial studies supportive care for patients with hematological malignancies undergoing hematopoietic cell transplant. Supportive care may improve quality of life in this patient population.
详细描述
PRIMARY OBJECTIVES:
I. Pilot a supportive care intervention that begins prior to transplantation and continues through the acute peritransplant period.
II. Determine the proportion of patients who enroll and the level of comfort / distress of hematopoietic cell transplant (HCT) patients who meet with the supportive care team.
III. Pilot data collection mechanisms and cost retrieval in preparation for a randomized clinical trial.
OUTLINE:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 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
- •Written informed consent
- •English as primary language
- •Planned autologous or allogeneic hematopoietic cell transplantation
- •Presence of co-morbidities (hematopoietic cell transplant co-morbidity index [HCT-CI] score 3 or greater), high risk disease (relapse risk > 25%), or a planned type of transplant (human leukocyte antigen [HLA]-mismatched allogeneic or myeloablative) that places the patient at a higher than average risk of non-relapse mortality or relapse
排除标准
- •Major psychiatric diagnosis that impairs cognitive functioning or is not controlled at the time of the approach, as judged by the patient's medical team
- •First transplant of a planned tandem procedure (the second transplant is eligible)
结局指标
主要结局
Study participation rates defined as the proportion of patients who consent to enroll
时间窗: Up to 5 months
Will mainly be descriptive.
Completion time for the supportive care consultation
时间窗: Up to 90 days post-treatment
Will mainly be descriptive.
Level of comfort / distress attributed to individual parts of the consultation
时间窗: Up to 90 days post-treatment
Will mainly be descriptive. The post-consultation scores measuring level of comfort or distress per topic in the supportive care consultation will be summarized per item.
Completeness of follow-up data collection, where completeness is defined by the proportion of instrument scores that can be calculated per given time point
时间窗: Up to 90 days post-treatment
Will mainly be descriptive. The completeness of follow-up data collection will be calculated and reported as a proportion of successfully completed scales vs. scales attempted to be collected or completed by patients.
次要结局
未报告次要终点