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临床试验/NCT01538706
NCT01538706已完成不适用

Hospital-based Home Care for Children With Cancer

Rigshospitalet, Denmark2 个研究点 分布在 1 个国家目标入组 75 人开始时间: 2008年8月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
75
试验地点
2
主要终点
Number of adverse events

研究概览

简要总结

The purpose of this non-randomized controlled intervention study was to evaluate the effects of a hospital-based home care program for children with cancer at a university hospital in Denmark. The hypothesis was that hospital-based home care could replace an out-patient visit or an in-patient admission without increasing the incidence of adverse events and costs. Furthermore, to enhance the children's quality of life and the psychosocial impact on the family.

详细描述

Hospital-based home care for children with cancer is widely used but controlled studies are relatively rare and the evidence base is limited. This prospective non-randomized controlled intervention study aimed to evaluate hospital-based home care for children with cancer.

A hospital-based home care program was conducted August 2008 - December 2009. Participants were children with cancer and their parents. The intervention group received part of their therapy, such as intravenous chemotherapy and antibiotics, as home care by a hospital-based home care nurse with paediatric-oncology experience. Children in the control group received all their treatment at the hospital.

Fifty-one children between 0 and 18 years were included in the home care program, and 47 children were included in the control group. After each home visit the parents answered a questionnaire. The results from 657 questionnaires showed that 100% were very satisfied or satisfied with home care and all would choose home care again, if offered as an option. There were no deaths or adverse effects of intravenous chemotherapy or antibiotics. A cost analysis based on the expenses associated with home care in correlation with standard cost of inpatient admissions and outpatient visits showed that the hospital-based home care programme was economically equal. The children's and the families' quality of life may be enhanced. The results indicate that the hospital-based home care program is safe, economically neutral and the parents' satisfaction with the program is major.

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
1 Month 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Clinical diagnosis of cancer
  • First-line treatment with intravenous therapy with a curative intent
  • Have not received a haematopoietic stem cell transplantation
  • Child and parent(s) speak and read Danish

排除标准

  • End-of-life treatment
  • Critical medical condition

结局指标

主要结局

Number of adverse events

时间窗: 17 months

At each home visit, the hospital-based home care nurse recorded details on the HBHC visits and safety according to the mandatory hospital guidelines for registrations of adverse events such as acute deteriorations of the general condition, and any medical errors.

次要结局

  • Costs of the intervention(17 months)
  • Participants' satisfaction with health care(At inclusion and 3 months after)
  • Healthrelated quality of life of the child with cancer(At inclusion and 3 months after)
  • Psychosocial impact of the family with a child of cancer(At inclusion and 3 months after)
  • Participants' satisfaction with the hospital-based home care program(12 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Helena Hansson

Clinial Researcher and Nurse Specialist

Rigshospitalet, Denmark

研究点 (2)

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