CancerDELI-DEVINCT02060578
Determinants of End-of-life Place of Care for Children Suffering From Cancer.
A study testing Questionnaire and interview in people with Cancer, run by Rennes University Hospital at 1 site in France.
Trial summary
Cancer is the second cause of over-one-year-old children mortality after accident. Survival rate is more than 70%, but in some cases, curative treatments are not sufficient and palliative support is implemented for those children in end of life. Pediatric guidelines about the place of end-of-life care are varied. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cancer
- What is being tested?
- Questionnaire and interview
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2014to Jul 2015
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Parents of a deceased child
- From cancer, after palliative phase
- Age of death under 18 years old.
- Death occurred in Brittany
- Death between 2005 and 2010
Who cannot join
- Parents of child who deceased after 2010 (respecting a bereavement delay)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: DELI-DEVI : Determinants of End-of-life Place of Care for Children Suffering From Cancer.
Cancer is the second cause of over-one-year-old children mortality after accident. Survival rate is more than 70%, but in some cases, curative treatments are not sufficient and palliative support is implemented for those children in end of life.
Pediatric guidelines about the place of end-of-life care are varied. On European scale, home is recommended (IMPaCCT study, 2007). In France, the 2008-2012 palliative care development program recommended home or initial hospital care unit. This program also supports implementation of mobile team rather than specific hospital units.
Read more
In Brittany, a pattern of regional palliative care resource team has been implemented since 2005. In oncology, further to the guidelines, end-of-life place of care is often discussed several times for each case. Sometimes occur a lot of returns between home and hospital, psychological difficulties, and difficulties to offer adapted care conditions. Finally, less than 30% of children in palliative care decease at home.
The primary objective is to identify main determinants of the place of palliative care in pediatric oncology.
The secondary objective is to clarify the factors of change comparing to the initial planned place.
Intervention :
Questionnaire completed by the parents Interview with the parents and the psychologist (University Rennes 2)
Number of subjects is : Parents of 68 to 93 children who died from cancer after a palliative phase, that means 136 to 186 parents.
Expected results and perspectives :
Using both quantitative and qualitative methods, expected results are the followings:
- Identification of the objective and subjective factors, which influenced the decision of the place of care.
- Determination of the factors of change comparing to the initial planned place.
Once identified, main factors could be the ones to pay attention to in order to help for initial decision, better anticipation of change of place and better guidance of palliative care organization wherever, at home or in hospital.
Results would be new information for research on palliative care for children but also for adults.
Finally, this work is part of an improving approach of palliative care, related to the development of open-care hospital networks. We can expect some public health impacts with new arguments to help for complementary recommendations.
Read the detailed description
Eligibility criteria :
Inclusion criteria are :
Parents of a deceased child
- From cancer, after palliative phase
- Age of death under 18 years old.
- Death occurred in Brittany
- Death between 2005 and 2010
Exclusion criterium is :
Parents of child who deceased after 2010 (respecting a bereavement delay)
Outcomes measures :
Primary study endpoint : Consideration or not by parents that they and/or their child had the choice of the end-of-life place of care.
Secondary study endpoints :
- objective factors : grade, occupational categories, marital status of parents, siblings, home conditions, access to the hospital, meeting with a professional of palliative care network, helpful general practitioner, volunteers, psychological support but also unexpected symptoms, needed nursing care which can explain a return from home to hospital for instance.
- subjective factors such as family or religious values, needs of intimacy, communication, support, sense of security, anxiety, fear, doubts about the next events.
- Conditions
- Cancer
- Being tested
- Questionnaire and interview
- Keywords
- Cancer palliative care, Dead child
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Questionnaire and interviewOther
Questionnaire completed by the parents Interview with the parents and the psychologist (University Rennes 2)
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Other | Questionnaire completed by the parents Interview with the parents and the psychologist (University Rennes 2) Receives: Other: Questionnaire and interview |
What is being measured
The primary outcome is the main question the study is designed to answer.
Consideration or not by parents that they and/or their child had the choice of the end-of-life place of care.
Consideration or not by parents that they and/or their child had the choice of the end-of-life place of care.
Measured: interview day
Secondary outcomes (2)
Objective factors
Objective factors : grade, occupational categories, marital status of parents, siblings, home conditions, access to the hospital, meeting with a professional of palliative care network, helpful general practitioner, volunteers, psychological support but also unexpected symptoms, needed nursing care which can explain a return from home to hospital for instance
Measured: Interview day
Subjective factors
Subjective factors such as family or religious values, needs of intimacy, communication, support, sense of security, anxiety, fear, doubts about the next events.
Measured: Interview day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2014 (estimated)
- Study startJan 2014
- Primary completionJul 2015
- Study completionJul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by Rennes University HospitalThe 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
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rennes University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Rennes 2
- Responsible party
- Sponsor
- Investigators
- Guillaume Robert, Principal investigator, Rennes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02060578
- Sponsor's protocol ID
- 35RC13_9749_DELI-DEVI
- Other IDs
- 13.04.08, 13.428, 913434
- Acronym
- DELI-DEVI
- Status last verified
- Dec 2015
- First submitted
- 17 Jan 2014
- Last updated
- 18 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- DELI-DEVI : Determinants of End-of-life Place of Care for Children Suffering From Cancer.
- ClinicalTrials.gov ID
- NCT02060578
- Acronym / sponsor ID
- DELI-DEVI / 35RC13_9749_DELI-DEVI
- Conditions
- Cancer
- Keywords
- Cancer palliative care, Dead child
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Rennes University HospitalUniversity, hospital or other
- Collaborators
- University of Rennes 2
- Study start
- Jan 2014
- Primary completion
- Jul 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 12 Feb 2014 (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.
Cancer is the second cause of over-one-year-old children mortality after accident. Survival rate is more than 70%, but in some cases, curative treatments are not sufficient and palliative support is implemented for those children in end of life.
Pediatric guidelines about the place of end-of-life care are varied. On European scale, home is recommended (IMPaCCT study, 2007). In France, the 2008-2012 palliative care development program recommended home or initial hospital care unit. This program also supports implementation of mobile team rather than specific hospital units.
In Brittany, a pattern of regional palliative care resource team has been implemented since 2005. In oncology, further to the guidelines, end-of-life place of care is often discussed several times for each case. Sometimes occur a lot of returns between home and hospital, psychological difficulties, and difficulties to offer adapted care conditions. Finally, less than 30% of children in palliative care decease at home.
The primary objective is to identify main determinants of the place of palliative care in pediatric oncology.
The secondary objective is to clarify the factors of change comparing to the initial planned place.
Intervention :
Questionnaire completed by the parents Interview with the parents and the psychologist (University Rennes 2)
Number of subjects is : Parents of 68 to 93 children who died from cancer after a palliative phase, that means 136 to 186 parents.
Expected results and perspectives :
Using both quantitative and qualitative methods, expected results are the followings:
- Identification of the objective and subjective factors, which influenced the decision of the place of care.
- Determination of the factors of change comparing to the initial planned place.
Once identified, main factors could be the ones to pay attention to in order to help for initial decision, better anticipation of change of place and better guidance of palliative care organization wherever, at home or in hospital.
Results would be new information for research on palliative care for children but also for adults.
Finally, this work is part of an improving approach of palliative care, related to the development of open-care hospital networks. We can expect some public health impacts with new arguments to help for complementary recommendations.
Detailed description
Eligibility criteria :
Inclusion criteria are :
Parents of a deceased child
- From cancer, after palliative phase
- Age of death under 18 years old.
- Death occurred in Brittany
- Death between 2005 and 2010
Exclusion criterium is :
Parents of child who deceased after 2010 (respecting a bereavement delay)
Outcomes measures :
Primary study endpoint : Consideration or not by parents that they and/or their child had the choice of the end-of-life place of care.
Secondary study endpoints :
- objective factors : grade, occupational categories, marital status of parents, siblings, home conditions, access to the hospital, meeting with a professional of palliative care network, helpful general practitioner, volunteers, psychological support but also unexpected symptoms, needed nursing care which can explain a return from home to hospital for instance.
- subjective factors such as family or religious values, needs of intimacy, communication, support, sense of security, anxiety, fear, doubts about the next events.
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention | Other | Other: Questionnaire and interviewQuestionnaire completed by the parents Interview with the parents and the psychologist (University Rennes 2) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Parents of a deceased child
- From cancer, after palliative phase
- Age of death under 18 years old.
- Death occurred in Brittany
- Death between 2005 and 2010
Key exclusion criteria (1 listed)
- Parents of child who deceased after 2010 (respecting a bereavement delay)
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 |
|---|---|---|
| Questionnaire and interviewQuestionnaire completed by the parents Interview with the parents and the psychologist (University Rennes 2) | Other | Intervention |
Primary outcome
Consideration or not by parents that they and/or their child had the choice of the end-of-life place of care.
Time frame: interview day
Consideration or not by parents that they and/or their child had the choice of the end-of-life place of care.
2 secondary outcomes
Objective factors
Time frame: Interview day
Subjective factors
Time frame: Interview day
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 18 Dec 2015.
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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.
Guillaume Robert principal investigator
Rennes University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Questionnaire and interview in people with Cancer, run by Rennes University Hospital at 1 site in France.
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 5 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 18 Dec 2015. 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 France. 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?
Consideration or not by parents that they and/or their child had the choice of the end-of-life place of care. (time frame: interview day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Dec 2015.