Impact of Home Care for Recipients of Allogeneic Haematopoietic Stem Cell Transplantation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- GRFS
研究概览
简要总结
Mixed methods study with focus groups interviews and a prospective observational cohort study aimed to investigate the impact of advanced home care on transplant specific outcomes and quality of life in recipients of allogeneic hematopoietic stem cell transplantation
详细描述
Study of advanced home care after allogeneic haematopoietic stem cell transplantation (allo-HSCT). The main objective is to investigate the impact of home care on transplant specific variables and quality of life (QoL). The main hypothesis is that home care patients will home care patients will have significantly better measured QoL than patients receiving in-hospital care during the first 6 weeks after allo-HSCT. The study will be conducted as part of routine care at the departement of haematology, Oslo University Hospital.
There are qualitative and quantitative aspects to the study. The qualitative part involves focus groups interviews with patients that have been treated with allo-HSCT and have recieved home care and their caregivers.
In the prospective observational cohort study data will be collected to compare patients receiving home care and patients treated in-hospital (control group). Patients in both groups wil answer the questionnaire EORTC QLQ-C30 once weekly for 6 weeks. In addition transplant- and treatment-specific variables will be collected and compares between the groups.
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
- •Consent competency and written informed consent to participation
- •Understanding and willing to comply with written and oral instructions in Norwegian
- •Planned treatment with allo-HSCT
- •ECOG performance status 0-2
- •Caregiver (age ≥18) present 24 hours a day during the aplastic phase
- •Travelling distance from residence to the hospital must be less than one hour.
排除标准
- •Not meeting inclusion criteria
- •Uncontrolled infection or other medical condtion unsuitable for out patient care
结局指标
主要结局
GRFS
时间窗: 1 year
GvHD-free, relapse-free survival
QoL
时间窗: 6 weeks
Quality of Life
次要结局
- GvHD(1 year)
- Infection(1 year)
- TRM(1 year)
研究者
Anders E. L. Myhre
Consultant Haematologist
Oslo University Hospital