CancerNCT02553148
Estimating the Global Need for Palliative Care for Children
An observational study of Cancer and Congenital Anomalies, run by International Children's Palliative Care Network at 1 site in United States.
Trial summary
A cross-sectional analysis of prevalence data from a stratified sample of 23 countries used to estimate the global need for palliative care for children aged 0-19 years. Prevalence data, from the Institute for Health Metrics and Evaluation, was for 12 major diagnostic groups needing children's palliative care… Read more about this study
- Who is it for?
- Ages Up to 19 yearsHealthy volunteers can take part
- Conditions the study is for
- Cancer, Congenital Anomalies, Cardiovascular Disease
- What is being tested?
- Need for children's palliative care
- How many people
- 18,837,613 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2014to Oct 2015
- Phase
- Observational
- 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 Up to 19 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: All children in sample countries with the following diagnoses included: all cancers (except non-malignant skin); HIV/AIDS; cardiovascular diseases; cirrhosis of liver; congenital anomalies; endocrine, blood, \& immune disorders; meningitis; kidney diseases; protein energy malnutrition; neurological conditions; neonatal conditions; drug-resistant tuberculosis. Cases with sequela not associated with need for palliative care were removed.
Who may be able to join
- have one of the conditions above
Who cannot join
- greater than 19 years of age
Trial locations and contacts
1 site in 1 country.
United States1 site
International Children's Palliative Care Network
Fairfax Station, Virginia, 22039
About this study
Official title: Estimating the Global Need for Palliative Care for Children: A Cross Sectional Analysis
A cross-sectional analysis of prevalence data from a stratified sample of 23 countries used to estimate the global need for palliative care for children aged 0-19 years. Prevalence data, from the Institute for Health Metrics and Evaluation, was for 12 major diagnostic groups needing children's palliative care according to WHO and UNICEF guidelines.
Read the detailed description
There is growing awareness that there are major gaps in access to children's palliative care (CPC) worldwide. Adults have a greater likelihood of receiving palliative care than children. Growing access to treatment services, and extended periods of wellness have led to some changes in the nature of the palliative care services required. Children are more resilient and more likely to require CPC for longer periods than adults.
It is against this background that UNICEF and the International Children's Palliative Care Network (ICPCN), in collaboration with national palliative care associations, began a joint analysis to develop methods to assess critical needs and gaps in CPC. The initial assessment, conducted in Kenya, South Africa and Zimbabwe, aimed to analyse existing secondary data on palliative care to estimate the palliative care need amongst children and explore key gaps in the response with service providers. A report on this research, the methods used, and the results for South Africa was published in 2014.
There is a lack of information regarding the actual need for palliative care for children, and assessment is a complicated process, due to uncertainty about the patient population and the nature of palliative care for children. Although there have been some studies focusing on the status of CPC in sub-Saharan Africa and the United Kingdom, there are differences in the scope and approach to the present study. A systematic review of the provision of CPC around the world, noted that over 65% of countries have no recognised CPC service provision, and concluded that service provision for CPC is not meeting the need in the majority of the world.
Generally, studies estimating need for palliative care for children are based on mortality statistics for chronic, incurable illnesses. Estimates focused on end-of-life care, as in the Global Atlas of Palliative Care at the End of Life do not account for the children that need palliative care well before the last year of life and underestimate the need.
The World Health Organization defines palliative care for children as a special, albeit closely related field to adult palliative care. An effort to define the many diseases and conditions requiring CPC a directory was published in 2013 with 376 potential diagnostic labels though the majority of deaths were from a small number.
- Conditions
- Cancer, Congenital Anomalies, Cardiovascular Disease, HIV
- Being tested
- Need for children's palliative care
- Keywords
- prevalence, epidemiology, palliative care, pediatric
- Medical subject headings
- Neoplasms, Congenital Abnormalities, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Need for children's palliative careOther
Need for children's palliative care
| Study group | Role | What they receive |
|---|---|---|
| Argentina | One of the 23 countries studied Receives: Other: Need for children's palliative care | |
| Armenia | One of the 23 countries studied Receives: Other: Need for children's palliative care | |
| Australia | One of the 23 countries studied Receives: Other: Need for children's palliative care | |
| Brazil | One of the 23 countries studied Receives: Other: Need for children's palliative care | |
| China | One of the 23 countries studied Receives: Other: Need for children's palliative care | |
| Egypt | One of the 23 countries studied Receives: Other: Need for children's palliative care | |
| Ethiopia | One of the 23 countries studied Receives: Other: Need for children's palliative care | |
| Germany | One of the 23 countries studied Receives: Other: Need for children's palliative care | |
| India | One of the 23 countries studied Receives: Other: Need for children's palliative care | |
| Indonesia | One of the 23 countries studied Receives: Other: Need for children's palliative care | |
| Jordan | One of the 23 countries studied Receives: Other: Need for children's palliative care | |
| Kenya | One of the 23 countries studied Receives: Other: Need for children's palliative care | |
| Kyrgyzstan | One of the 23 countries studied Receives: Other: Need for children's palliative care | |
| Malaysia | One of the 23 countries studied Receives: Other: Need for children's palliative care | |
| Malawi | One of the 23 countries studied Receives: Other: Need for children's palliative care | |
| Mexico | One of the 23 countries studied Receives: Other: Need for children's palliative care | |
| Russia | One of the 23 countries studied Receives: Other: Need for children's palliative care | |
| Serbia | One of the 23 countries studied Receives: Other: Need for children's palliative care | |
| South Africa | One of the 23 countries studied Receives: Other: Need for children's palliative care | |
| Tajikistan | One of the 23 countries studied Receives: Other: Need for children's palliative care | |
| United Kingdom | One of the 23 countries studied Receives: Other: Need for children's palliative care | |
| United States | One of the 23 countries studied Receives: Other: Need for children's palliative care | |
| Zimbabwe | One of the 23 countries studied Receives: Other: Need for children's palliative care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Need for Children's Palliative Care
Estimation of need in a stratified sample of countries to derive a global estimate
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2015 (estimated)
- Study startJun 2014
- Primary completionSep 2015
- Study completionOct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for CancerStudies of the same condition, open and under way.
- 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
- Observational
- Time perspective
- Retrospective
- Enrolment
- 18,837,613 participants (actual)
Sponsor and investigators
- Lead sponsor
- International Children's Palliative Care Network
- Sponsor type
- University, hospital or other
- Collaborators
- UNICEF
- Responsible party
- Sponsor
- Investigators
- Joan Marston, MA, RN, Study chair, International Children's Palliative Care NetworkStephen R Connor, PhD, Principal investigator, International Children's Palliative Care Network
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02553148
- Sponsor's protocol ID
- 0001
- Status last verified
- Feb 2016
- First submitted
- 19 Aug 2015
- Last updated
- 23 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: A manuscript reporting results has been prepared and is being reviewed for journal publication.
Publications
Institute of Medicine (US) Committee on Palliative and End-of-Life Care for Children and Their Families; Field MJ, Behrman RE, editors. When Children Die: Improving Palliative and End-of-Life Care for Children and Their Families. Washington (DC): National Academies Press (US); 2003. Available from http://www.ncbi.nlm.nih.gov/books/NBK220818/
PubMed 25057608Harding R, Brits H, Penfold S. Paediatric antiretroviral therapy outcomes under HIV hospice care in South Africa. Int J Palliat Nurs. 2009 Mar;15(3):142-5. doi: 10.12968/ijpn.2009.15.3.41093.
PubMed 19537535Connor S, Sisimayi C, Downing J, King E, Lim Ah Ken P, Yates R, Marston J. Assessment of the need for palliative care for children in South Africa. Int J Palliat Nurs. 2014 Mar;20(3):130-4. doi: 10.12968/ijpn.2014.20.3.130.
PubMed 24675539Hain R, Heckford E, McCulloch R. Paediatric palliative medicine in the UK: past, present, future. Arch Dis Child. 2012 Apr;97(4):381-4. doi: 10.1136/archdischild-2011-300432. Epub 2011 Oct 28.
PubMed 22039176Fraser LK, Miller M, Hain R, Norman P, Aldridge J, McKinney PA, Parslow RC. Rising national prevalence of life-limiting conditions in children in England. Pediatrics. 2012 Apr;129(4):e923-9. doi: 10.1542/peds.2011-2846. Epub 2012 Mar 12.
PubMed 22412035Knapp C, Woodworth L, Wright M, Downing J, Drake R, Fowler-Kerry S, Hain R, Marston J. Pediatric palliative care provision around the world: a systematic review. Pediatr Blood Cancer. 2011 Sep;57(3):361-8. doi: 10.1002/pbc.23100. Epub 2011 Mar 17.
PubMed 21416582Hain R, Devins M, Hastings R, Noyes J. Paediatric palliative care: development and pilot study of a 'Directory' of life-limiting conditions. BMC Palliat Care. 2013 Dec 11;12(1):43. doi: 10.1186/1472-684X-12-43.
PubMed 24330676
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Estimating the Global Need for Palliative Care for Children: A Cross Sectional Analysis
- ClinicalTrials.gov ID
- NCT02553148
- Acronym / sponsor ID
- 0001
- Conditions
- Cancer, Congenital Anomalies, Cardiovascular Disease, HIV
- Keywords
- prevalence, epidemiology, palliative care, pediatric
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 18,837,613 participants (actual)
- Lead sponsor
- International Children's Palliative Care NetworkUniversity, hospital or other
- Collaborators
- UNICEF
- Study start
- Jun 2014
- Primary completion
- Sep 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 17 Sep 2015 (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.
A cross-sectional analysis of prevalence data from a stratified sample of 23 countries used to estimate the global need for palliative care for children aged 0-19 years. Prevalence data, from the Institute for Health Metrics and Evaluation, was for 12 major diagnostic groups needing children's palliative care according to WHO and UNICEF guidelines.
Detailed description
There is growing awareness that there are major gaps in access to children's palliative care (CPC) worldwide. Adults have a greater likelihood of receiving palliative care than children. Growing access to treatment services, and extended periods of wellness have led to some changes in the nature of the palliative care services required. Children are more resilient and more likely to require CPC for longer periods than adults.
It is against this background that UNICEF and the International Children's Palliative Care Network (ICPCN), in collaboration with national palliative care associations, began a joint analysis to develop methods to assess critical needs and gaps in CPC. The initial assessment, conducted in Kenya, South Africa and Zimbabwe, aimed to analyse existing secondary data on palliative care to estimate the palliative care need amongst children and explore key gaps in the response with service providers. A report on this research, the methods used, and the results for South Africa was published in 2014.
There is a lack of information regarding the actual need for palliative care for children, and assessment is a complicated process, due to uncertainty about the patient population and the nature of palliative care for children. Although there have been some studies focusing on the status of CPC in sub-Saharan Africa and the United Kingdom, there are differences in the scope and approach to the present study. A systematic review of the provision of CPC around the world, noted that over 65% of countries have no recognised CPC service provision, and concluded that service provision for CPC is not meeting the need in the majority of the world.
Generally, studies estimating need for palliative care for children are based on mortality statistics for chronic, incurable illnesses. Estimates focused on end-of-life care, as in the Global Atlas of Palliative Care at the End of Life do not account for the children that need palliative care well before the last year of life and underestimate the need.
The World Health Organization defines palliative care for children as a special, albeit closely related field to adult palliative care. An effort to define the many diseases and conditions requiring CPC a directory was published in 2013 with 376 potential diagnostic labels though the majority of deaths were from a small number.
Study design
- Time perspective
- Retrospective
- Number of arms
- 23
| Arm | Type | Receives |
|---|---|---|
| Argentina | – | Other: Need for children's palliative careOne of the 23 countries studied |
| Armenia | – | Other: Need for children's palliative careOne of the 23 countries studied |
| Australia | – | Other: Need for children's palliative careOne of the 23 countries studied |
| Brazil | – | Other: Need for children's palliative careOne of the 23 countries studied |
| China | – | Other: Need for children's palliative careOne of the 23 countries studied |
| Egypt | – | Other: Need for children's palliative careOne of the 23 countries studied |
| Ethiopia | – | Other: Need for children's palliative careOne of the 23 countries studied |
| Germany | – | Other: Need for children's palliative careOne of the 23 countries studied |
| India | – | Other: Need for children's palliative careOne of the 23 countries studied |
| Indonesia | – | Other: Need for children's palliative careOne of the 23 countries studied |
| Jordan | – | Other: Need for children's palliative careOne of the 23 countries studied |
| Kenya | – | Other: Need for children's palliative careOne of the 23 countries studied |
| Kyrgyzstan | – | Other: Need for children's palliative careOne of the 23 countries studied |
| Malaysia | – | Other: Need for children's palliative careOne of the 23 countries studied |
| Malawi | – | Other: Need for children's palliative careOne of the 23 countries studied |
| Mexico | – | Other: Need for children's palliative careOne of the 23 countries studied |
| Russia | – | Other: Need for children's palliative careOne of the 23 countries studied |
| Serbia | – | Other: Need for children's palliative careOne of the 23 countries studied |
| South Africa | – | Other: Need for children's palliative careOne of the 23 countries studied |
| Tajikistan | – | Other: Need for children's palliative careOne of the 23 countries studied |
| United Kingdom | – | Other: Need for children's palliative careOne of the 23 countries studied |
| United States | – | Other: Need for children's palliative careOne of the 23 countries studied |
| Zimbabwe | – | Other: Need for children's palliative careOne of the 23 countries studied |
Who may qualify
- Ages
- Up to 19 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- All children in sample countries with the following diagnoses included: all cancers (except non-malignant skin); HIV/AIDS; cardiovascular diseases; cirrhosis of liver; congenital anomalies; endocrine, blood, \& immune disorders; meningitis; kidney diseases; protein energy malnutrition; neurological conditions; neonatal conditions; drug-resistant tuberculosis. Cases with sequela not associated with need for palliative care were removed.
Key inclusion criteria (1 listed)
- have one of the conditions above
Key exclusion criteria (1 listed)
- greater than 19 years of age
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 |
|---|---|---|
| Need for children's palliative careNeed for children's palliative care | Other | Argentina, Armenia, Australia, Brazil, China, Egypt, Ethiopia, Germany, India, Indonesia, Jordan, Kenya, Kyrgyzstan, Malawi, Malaysia, Mexico, Russia, Serbia, South Africa, Tajikistan, United Kingdom, United States, Zimbabwe |
Primary outcome
Need for Children's Palliative Care
Time frame: 1 year
Estimation of need in a stratified sample of countries to derive a global estimate
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 23 Feb 2016.
- Background: PubMed 25057608Institute of Medicine (US) Committee on Palliative and End-of-Life Care for Children and Their Families; Field MJ, Behrman RE, editors. When Children Die: Improving Palliative and End-of-Life Care for Children and Their Families. Washington (DC): National Academies Press (US); 2003. Available from http://www.ncbi.nlm.nih.gov/books/NBK220818/
- Background: PubMed 19537535Harding R, Brits H, Penfold S. Paediatric antiretroviral therapy outcomes under HIV hospice care in South Africa. Int J Palliat Nurs. 2009 Mar;15(3):142-5. doi: 10.12968/ijpn.2009.15.3.41093.
- Background: PubMed 24675539Connor S, Sisimayi C, Downing J, King E, Lim Ah Ken P, Yates R, Marston J. Assessment of the need for palliative care for children in South Africa. Int J Palliat Nurs. 2014 Mar;20(3):130-4. doi: 10.12968/ijpn.2014.20.3.130.
- Background: PubMed 22039176Hain R, Heckford E, McCulloch R. Paediatric palliative medicine in the UK: past, present, future. Arch Dis Child. 2012 Apr;97(4):381-4. doi: 10.1136/archdischild-2011-300432. Epub 2011 Oct 28.
- Background: PubMed 22412035Fraser LK, Miller M, Hain R, Norman P, Aldridge J, McKinney PA, Parslow RC. Rising national prevalence of life-limiting conditions in children in England. Pediatrics. 2012 Apr;129(4):e923-9. doi: 10.1542/peds.2011-2846. Epub 2012 Mar 12.
- Background: PubMed 21416582Knapp C, Woodworth L, Wright M, Downing J, Drake R, Fowler-Kerry S, Hain R, Marston J. Pediatric palliative care provision around the world: a systematic review. Pediatr Blood Cancer. 2011 Sep;57(3):361-8. doi: 10.1002/pbc.23100. Epub 2011 Mar 17.
- Background: PubMed 24330676Hain R, Devins M, Hastings R, Noyes J. Paediatric palliative care: development and pilot study of a 'Directory' of life-limiting conditions. BMC Palliat Care. 2013 Dec 11;12(1):43. doi: 10.1186/1472-684X-12-43.
- Individual participant dataSharing planned: Yes. A manuscript reporting results has been prepared and is being reviewed for journal publication.
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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.
Joan Marston, MA, RN study chair
International Children's Palliative Care Network
Stephen R Connor, PhD principal investigator
International Children's Palliative Care Network
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer and Congenital Anomalies, run by International Children's Palliative Care Network at 1 site in United States.
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 1 inclusion and 1 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 23 Feb 2016. 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 United States. 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?
Need for Children's Palliative Care (time frame: 1 year). 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 NCT02553148, which also lists 7 linked publications.
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 23 Feb 2016.