Determinants of End-of-life Place of Care for Children Suffering From Cancer.

Cancer Clinical Trial

— DELI-DEVI  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02060578
• Other study ID #: 35RC13_9749_DELI-DEVI
• Secondary ID: 13.04.0813.42891
• Status: Completed
• Phase: N/A
• First received: January 17, 2014
• Last updated: December 17, 2015
• Start date: January 2014
• Est. completion date: July 2015

Study information

• Verified date: December 2015
• Source: Rennes University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: National Consultative Ethics Committee for Health and Life SciencesFrance: The Commission nationale de l’informatique et des libertés
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: July 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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)

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Cancer

Intervention

Other:
• Questionnaire and interview
Questionnaire completed by the parents Interview with the parents and the psychologist (University Rennes 2)

Locations

Country	Name	City	State
France	Rennes University Hospital	Rennes	Brittany

Sponsors (2)

Lead Sponsor	Collaborator
Rennes University Hospital	University Rennes 2

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	interview day	No
Secondary	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	Interview day	No
Secondary	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.	Interview day	No