NeoplasmsNCT01538706
Hospital-based Home Care for Children With Cancer
A study testing Hospital-based home care in people with Neoplasms and Children, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
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. Read more about this study
- Who is it for?
- Ages 1 month to 18 years
- What is being tested?
- Hospital-based home care
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteDenmark
- Study dates
- Aug 2008to Oct 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 month to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- End-of-life treatment
- Critical medical condition
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Being tested
- Hospital-based home care
- Keywords
- Hospital-based home care, Pediatric oncology
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hospital-based home careOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Hospital-based home care | Experimental | 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. Receives: Other: Hospital-based home care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 17 months
Secondary outcomes (5)
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.
Measured: 17 months
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.
Measured: At inclusion and 3 months after
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.
Measured: At inclusion and 3 months after
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.
Measured: At inclusion and 3 months after
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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2012 (estimated)
- Study startAug 2008
- Primary completionDec 2009
- Study completionOct 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for NeoplasmsStudies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Collaborators
- Copenhagen University Hospital, Denmark
- Responsible party
- Principal investigator, Helena Hansson, Copenhagen University Hospital, Rigshospitalet
- Investigators
- Helena Hansson, MSc, Principal investigator, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01538706
- Sponsor's protocol ID
- 959584438
- Status last verified
- Feb 2012
- First submitted
- 9 Nov 2011
- Last updated
- 24 Feb 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 21848580
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hospital-based Home Care for Children With Cancer
- ClinicalTrials.gov ID
- NCT01538706
- Acronym / sponsor ID
- 959584438
- Keywords
- Hospital-based home care, Pediatric oncology
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Collaborators
- Copenhagen University Hospital, Denmark
- Study start
- Aug 2008
- Primary completion
- Dec 2009 (actual)
- Study completion
- Oct 2010 (actual)
- First posted
- 24 Feb 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hospital-based home care | Experimental | Other: Hospital-based home carePatients 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. |
Who may qualify
- Ages
- 1 month to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- End-of-life treatment
- Critical medical condition
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hospital-based home careLow-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. | Other | Hospital-based home care |
Primary outcome
Number of adverse events
Time frame: 17 months
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.
5 secondary outcomes
Costs of the intervention
Time frame: 17 months
Healthrelated quality of life of the child with cancer
Time frame: At inclusion and 3 months after
Psychosocial impact of the family with a child of cancer
Time frame: At inclusion and 3 months after
Participants' satisfaction with health care
Time frame: At inclusion and 3 months after
Participants' satisfaction with the hospital-based home care program
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2012.
- Results publication: PubMed 21848580Hansson 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Helena Hansson, MSc principal investigator
Copenhagen University Hospital, Rigshospitalet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hospital-based home care in people with Neoplasms and Children, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Feb 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of adverse events (time frame: 17 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01538706, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2012; AzTrials last refreshed its copy on 7 Nov 2026.