Hospital-based Home Care for Children With Cancer

Neoplasms Clinical Trial

Official title:

Hospital-based Home Care for Children With Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01538706
• Other study ID #: 959584438
• Status: Completed
• Phase: N/A
• First received: November 9, 2011
• Last updated: February 23, 2012
• Start date: August 2008
• Est. completion date: October 2010

Study information

• Verified date: February 2012
• Source: Rigshospitalet, Denmark
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: National Board of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: October 2010
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 1 Month to 18 Years

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Children
• Neoplasms

Intervention

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.

Locations

Country	Name	City	State
Denmark	Copenhagen university hospital, Rigshospitalet	Copenhagen

Sponsors (2)

Lead Sponsor	Collaborator
Rigshospitalet, Denmark	Copenhagen University Hospital, Denmark

Country where clinical trial is conducted

Denmark, 

References & Publications (1)

Hansson H, Kjaergaard H, Schmiegelow K, Hallström 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.1365-2354.2011.0128 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of adverse events	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.	17 months	Yes
Secondary	Costs of the intervention	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.	17 months	No
Secondary	Healthrelated quality of life of the child with cancer	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.	At inclusion and 3 months after	No
Secondary	Psychosocial impact of the family with a child of cancer	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.	At inclusion and 3 months after	No
Secondary	Participants' satisfaction with health care	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.	At inclusion and 3 months after	No
Secondary	Participants' satisfaction with the hospital-based home care program	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.	12 months	No