Hospital-based Home Care for Children With Cancer

This study has been completed.
Sponsor:
Collaborator:
Copenhagen University Hospital, Denmark
Information provided by (Responsible Party):
Helena Hansson, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier:
NCT01538706
First received: November 9, 2011
Last updated: February 23, 2012
Last verified: February 2012
  Purpose

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.


Condition Intervention
Neoplasms
Children
Other: Hospital-based home care

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Hospital-based Home Care for Children With Cancer

Resource links provided by NLM:


Further study details as provided by Rigshospitalet, Denmark:

Primary Outcome Measures:
  • Number of adverse events [ Time Frame: 17 months ] [ Designated as safety issue: Yes ]
    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.


Secondary Outcome Measures:
  • Costs of the intervention [ Time Frame: 17 months ] [ Designated as safety issue: No ]
    The 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 cancer [ Time Frame: At inclusion and 3 months after ] [ Designated as safety issue: No ]
    A 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 cancer [ Time Frame: At inclusion and 3 months after ] [ Designated as safety issue: No ]
    A 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 care [ Time Frame: At inclusion and 3 months after ] [ Designated as safety issue: No ]
    A 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 program [ Time Frame: 12 months ] [ Designated as safety issue: No ]

    A 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.



Enrollment: 75
Study Start Date: August 2008
Study Completion Date: October 2010
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
Other: 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.

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

Ages Eligible for Study:   1 Month to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01538706

Locations
Denmark
Copenhagen university hospital, Rigshospitalet
Copenhagen, Denmark, 2100
Sponsors and Collaborators
Rigshospitalet, Denmark
Copenhagen University Hospital, Denmark
Investigators
Principal Investigator: Helena Hansson, MSc Rigshospitalet, Denmark
  More Information

Publications:
Responsible Party: Helena Hansson, Clinial Researcher and Nurse Specialist, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier: NCT01538706     History of Changes
Other Study ID Numbers: 959584438
Study First Received: November 9, 2011
Last Updated: February 23, 2012
Health Authority: Denmark: National Board of Health

Keywords provided by Rigshospitalet, Denmark:
Hospital-based home care
Pediatric oncology

Additional relevant MeSH terms:
Neoplasms

ClinicalTrials.gov processed this record on August 21, 2014