Shared Care: Patient-Centered Management After Hematopoietic Cell Transplantation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 404
- 试验地点
- 18
- 主要终点
- European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire for Cancer (EORTC QLQ-C30) at Day 180
研究概览
简要总结
This research study aims to evaluate the effectiveness of allowing patients who have had a hematopoietic cell transplant to receive some of their post-transplant care with a local oncologist rather than returning to the transplant center for all of their follow-up.
详细描述
Hematopoietic Cell Transplantation (HCT) - also known as bone marrow transplant - is only available at select centers in the United States which can collect and store stem cells, as well as care for patients before their new immune system cells take hold. For this reason, many patients who undergo HCT live at great distances from their HCT center. Also, after hospital discharge, the first 180 days post-HCT are very important, as patients must be managed closely with frequent follow-up visits.
A potential way to make life easier for HCT patients is to allow some of the post-transplant care to be provided by local oncologists who practice closer to where patients live. This could reduce the burden on patients and their caregivers; however, it is not known if a shared care model would ultimately benefit them. The investigators want to assess the effectiveness of a Shared Care program which allows patients to receive half of their post-HCT care at the HCT center, and the other half with their local oncologist
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Scheduled to receive an allogeneic HCT at the Dana-Farber Inpatient Hospital or BWH under the care of a DFCI physician
- •Residence in New York, Maine, New Hampshire, Vermont, Connecticut, or Massachusetts
- •Referred from or live less than 1 hour from one of the local participating centers.
- •Ability to read English (to fill out standard QOL forms)
排除标准
- •Age <18 years of age
- •Scheduled to receive an autologous HCT
- •Has received an allogeneic transplant in the past; scheduled to receive a second allogeneic transplant
- •Did not receive an allogeneic HCT at Dana-Farber
- •Does not live in New York, Maine, New Hampshire, Vermont, Connecticut, or Massachusetts
结局指标
主要结局
European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire for Cancer (EORTC QLQ-C30) at Day 180
时间窗: 180 days
European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire for Cancer GLOBAL health status subscale. Higher values (range: 0 to 100) represent higher quality of life. This was selected by a consensus of patient stakeholders.
Functional Assessment of Cancer Therapy - Bone Marrow Transplantation (FACT-BMT) at Day 180
时间窗: 180 days
Functional Assessment of Cancer Therapy - Bone Marrow Transplantation TOTAL score. The TOTAL score is a summed combination of the Physical Well-Being (PWB), Social/Family Well-Being (SWB), Emotional Well-Being (EWB), Functional Well-Being (FWB) and Bone Marrow Transplant Subscales (BMTS). Higher scores (range: 0 - 148) represent better transplant-related quality of life. It was selected by a consensus of patient stakeholders as a patient-reported outcome (PRO) for the trial.
100-day Non-relapse Mortality (NRM) for Patients in Shared Care Versus Usual Care
时间窗: 100 days
Non-relapse mortality is a common measure to assess early outcomes for stem cell transplant, given that there can be a high level of early mortality from the transplant itself even in the absence of relapse. It is defined as a death occurring while in continuous remission. NRM is reported as a binary outcome.
次要结局
未报告次要终点
研究者
Gregory A. Abel, MD
Gregory A. Abel. MD, MPH
Dana-Farber Cancer Institute