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Determinants of End-of-life Place of Care for Children Suffering From Cancer. (DELI-DEVI)

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ClinicalTrials.gov Identifier: NCT02060578
Recruitment Status : Completed
First Posted : February 12, 2014
Last Update Posted : December 18, 2015
Sponsor:
Collaborator:
University Rennes 2
Information provided by (Responsible Party):
Rennes University Hospital

Brief 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. 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.


Condition or disease Intervention/treatment Phase
Cancer Other: Questionnaire and interview Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 45 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: DELI-DEVI : Determinants of End-of-life Place of Care for Children Suffering From Cancer.
Study Start Date : January 2014
Actual Primary Completion Date : July 2015
Actual Study Completion Date : July 2015

Arm Intervention/treatment
Intervention
Questionnaire completed by the parents Interview with the parents and the psychologist (University Rennes 2)
Other: Questionnaire and interview
Questionnaire completed by the parents Interview with the parents and the psychologist (University Rennes 2)




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Objective factors [ Time Frame: Interview day ]
    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

  2. Subjective factors [ Time Frame: Interview day ]
    Subjective factors such as family or religious values, needs of intimacy, communication, support, sense of security, anxiety, fear, doubts about the next events.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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 Criteria:

Parents of child who deceased after 2010 (respecting a bereavement delay)


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02060578


Locations
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France
Rennes University Hospital
Rennes, Brittany, France, 35033
Sponsors and Collaborators
Rennes University Hospital
University Rennes 2
Investigators
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Principal Investigator: Guillaume Robert Rennes University Hospital

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Responsible Party: Rennes University Hospital
ClinicalTrials.gov Identifier: NCT02060578     History of Changes
Other Study ID Numbers: 35RC13_9749_DELI-DEVI
13.04.08 ( Other Identifier: CPP Ouest III (Poitiers) )
13.428 ( Other Identifier: CCTIRS )
913434 ( Other Identifier: CNIL )
First Posted: February 12, 2014    Key Record Dates
Last Update Posted: December 18, 2015
Last Verified: December 2015

Keywords provided by Rennes University Hospital:
Cancer palliative care
Dead child