Clinical trial NCT01538706: Hospital-based Home Care for Children With Cancer
Official title: Hospital-based Home Care for Children With Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Neoplasms
Children
Keywords: Hospital-based home care
Pediatric oncology
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
Collaborators: name: Copenhagen University Hospital, Denmark
First posted: 2012-02-24
Enrollment: 75
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* End-of-life treatment
* Critical medical condition

Primary outcomes:
measure: Number of adverse events
timeFrame: 17 months
Secondary outcomes:
measure: Costs of the intervention
timeFrame: 17 months
measure: Healthrelated quality of life of the child with cancer
timeFrame: At inclusion and 3 months after
measure: Psychosocial impact of the family with a child of cancer
timeFrame: At inclusion and 3 months after
measure: Participants' satisfaction with health care
timeFrame: At inclusion and 3 months after
measure: Participants' satisfaction with the hospital-based home care program
timeFrame: 12 months
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Copenhagen university hospital, Rigshospitalet
Study officials:
affiliation: Rigshospitalet, Denmark
name: Helena Hansson, MSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hansson H, Kjaergaard H, Schmiegelow K, Hallstrom I. Hospital-based home care for children with cancer: a qualitative exploration of family members' experiences in Denmark. Eur J Cancer Care (Engl). 2012 Jan;21(1):59-66. doi: 10.1111/j.1365-2354.2011.01280.x. Epub 2011 Aug 18.