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Hospital-based Home Care for Children With Cancer

Hospital-based Home Care for Children With Cancer

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01538706
Enrollment
75
Registered
2012-02-24
Start date
2008-08-31
Completion date
2010-10-31
Last updated
2012-02-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Children, Neoplasms

Keywords

Hospital-based home care, Pediatric oncology

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.

Interventions

OTHERHospital-based home care

Low-intensive intravenous antibiotics b) intravenous low-toxic chemotherapy c) blood samples drawn from the central venous catheter or peripheral vein d) subcutaneous injections e) nutrition treatment f) pain management (e.g. controlling an intravenous morphine pump g) supportive care e.g. changing dressings.

Sponsors

Copenhagen University Hospital, Denmark
CollaboratorOTHER
Rigshospitalet, Denmark
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
1 Months to 18 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Number of adverse events17 monthsAt 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.

Secondary

MeasureTime frameDescription
Costs of the intervention17 monthsThe costs for the health care service were evaluated by comparing the hospital-based home care related operational e.g. petrol and pay roll costs plus overhead costs, with the billed costs for an out-patient visit or in-patient admission at the hospital.
Healthrelated quality of life of the child with cancerAt inclusion and 3 months afterA questionnaire booklet was developed to compare the psychosocial impact on the child and the family with home care and standard care. The child's general health-related quality of life was assessed by the PedsQL 4.0 Generic Core Scale, which consists of four dimensions and a total score of all dimensions is computed as well as a physical and psychosocial summary score. The child's disease-specific health-related quality of life was assessed by the PedsQL 3.0 Cancer Module, which consists of seven dimensions without a total score.
Psychosocial impact of the family with a child of cancerAt inclusion and 3 months afterA questionnaire booklet was developed to compare the psychosocial impact on the child and the family with home care and standard care. The psychosocial impact on the family was assessed by PedsQL 2.0 Family Impact Module, which consists of 8 dimensions with a total score as well as the parent's health-related quality of life and family functioning summary score.
Participants' satisfaction with health careAt inclusion and 3 months afterA questionnaire booklet was developed to compare the psychosocial impact on the child and the family with home care and standard care. The participants' satisfaction with health care was assessed by PedsQL Healthcare Satisfaction Generic Module measures the parents'/guardians' satisfaction with health care in general in six dimensions: information, inclusion of family, communication, technical skills, emotional needs, and overall satisfaction. A total score of all dimensions is computed.
Participants' satisfaction with the hospital-based home care program12 monthsA one-page evaluation form to measure the parents' and children's perceptions of security, satisfaction with home care and preference for care was developed with a 5-point Likert- scale ranging from not at all to very much. The parents' also scored overall preference for standard vs. home care was scored with two alternative responses (yes or no) and they were asked whether they would choose a home care visit again instead of a corresponding hospital visit if they had the opportunity. The evaluation forms were collected after each home visit only during the first 12 months of the program.

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026