Hospital-based Home Care for Children With Cancer

NCT ID: NCT01538706

Last Updated: 2012-02-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 75 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-08-31
• Study Completion Date: 2010-10-31

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.

Conditions

Neoplasms; Children

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Hospital-based home care

Patients were included if below the age of 18, had been diagnosed with any type of cancer at least one month prior to inclusion, on intravenous anticancer therapy with a curative intent, and the parent was fluent in speaking and reading Danish. Patients living within a radius of 50 kilometres from the hospital were assigned to the home care program. Moreover, patients were assigned to one of three groups according to the geographical distance from the hospital and timing of the inclusion period: (1) home care group if participating in the program, (2) historical standard care group for an eight-month period before the program started regardless of their residence distance from the hospital, and (3) concurrent standard care group if living more than 50 km from the university hospital.

Group Type: EXPERIMENTAL

Hospital-based home care

Intervention Type: OTHER

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.

Interventions

Hospital-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.

Intervention Type: OTHER

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

• Minimum Eligible Age: 1 Month
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Copenhagen University Hospital, Denmark

OTHER

Sponsor Role: collaborator

Rigshospitalet, Denmark

OTHER

Sponsor Role: lead

Responsible Party

Helena Hansson

Clinial Researcher and Nurse Specialist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Helena Hansson, MSc

Role: PRINCIPAL_INVESTIGATOR

Rigshospitalet, Denmark

Locations

Copenhagen university hospital, Rigshospitalet

Copenhagen, , Denmark

Countries

Denmark

References

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.

Reference Type: RESULT

PMID: 21848580 (View on PubMed)

Other Identifiers

959584438

Identifier Type: -

Identifier Source: org_study_id