A Controlled Study of Stem Cell Transplantation Medical Home Care Compared to Standard Hospital Care
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 56
- 试验地点
- 2
- 主要终点
- Bowel Microbiota
研究概览
简要总结
The primary goal with this study is to document whether patients can maintain their normal bowel microbiota by staying at home compared to those who live at home but are treated in clinic, and those who are treated in the hospital. In addition, the investigators would predict that the quality of life will be higher for those patients treated at the medical home compared to those that stay at the hospital. The investigators also predict that the costs associated with this approach will be significantly lower compared to hospitalized patients. Finally, the investigators propose that the treatment related morbidities and mortality will not be different between the two groups.
详细描述
Subjects enrolled in the medical home arm and those serving as concurrent controls will have the following studies:
- Stool collection for analysis at time 0 (prior to preparatory regimen) and then weekly for the first four weeks, at day 60 and 100.
- The PG-SGA, FACT-BMT and other patient-reported symptom instruments will be collected weekly for the first 4 weeks, at day 60, 100 and patients will be required to complete a daily food diary.
- Other assessments for toxicities or GVHD will proceed as per current standard of care, for a total blood draw amount of 100 mls from home care subjects and concurrent controls.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Scheduled to undergo a hematopoietic stem cell transplant for any cancer or non-cancer illness from any autologous, related or unrelated donor source including bone marrow, peripheral blood progenitor cell, or umbilical cord blood
- •Age 18-80 years of age
- •Karnofsky Performance Scale (KPS) > 80
- •A home that is deemed, upon inspection, in suitable condition to serve as a medical home, within a 90-minute driving distance of Duke (home care group only)
排除标准
- •Lack of a caregiver
- •Pregnant women (It is standard of care to assess for pregnancy for all females of child-bearing potential with a serum beta human chorionic gonadotropin (HCG) test within 7 days of starting the preparative regimen prior to transplant. No additional research pregnancy testing will occur.)
- •Patients with a documented active infection prior to starting their preparative regimen. This includes grade 3 or higher viral, bacterial, or fungal infection.
研究组 & 干预措施
Home Care
This is the arm for patients who receive their transplant care in their homes.
干预措施: Home Care (Other)
Hospital Care
Standard of care for stem cell transplant recipients where the aftercare is done in hospital.
Clinic Care
Standard of care for stem cell transplant recipients who live at home but receive aftercare in the daily outpatient clinic.
结局指标
主要结局
Bowel Microbiota
时间窗: 100 days
The bowel microbiota before and during the first 100 days.
次要结局
- Incidence of acute Graft Versus Host Disease (GVHD)(100 days)
- Treatment related morbidities and mortalities(100 Days)
- Costs of care(100 Days)
- Nutritional status using the PG-SGA assessment tool(100 days)
- Quality Of Life Assessment (QOL)(100 Days)