NCT02060578

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at P25-P50 for not_applicable cancer

Timeline
Completed

Started Jan 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2014

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

January 17, 2014

Completed
26 days until next milestone

First Posted

Study publicly available on registry

February 12, 2014

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2015

Completed
Last Updated

December 18, 2015

Status Verified

December 1, 2015

Enrollment Period

1.5 years

First QC Date

January 17, 2014

Last Update Submit

December 17, 2015

Conditions

Keywords

Cancer palliative careDead child

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (2)

  • Objective factors

    Interview day

  • Subjective factors

    Interview day

Study Arms (1)

Intervention

OTHER

Questionnaire completed by the parents Interview with the parents and the psychologist (University Rennes 2)

Other: Questionnaire and interview

Interventions

Questionnaire completed by the parents Interview with the parents and the psychologist (University Rennes 2)

Intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rennes University Hospital

Rennes, Brittany Region, 35033, France

Location

MeSH Terms

Conditions

Neoplasms

Interventions

Surveys and QuestionnairesInterviews as Topic

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Guillaume Robert

    Rennes University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 17, 2014

First Posted

February 12, 2014

Study Start

January 1, 2014

Primary Completion

July 1, 2015

Study Completion

July 1, 2015

Last Updated

December 18, 2015

Record last verified: 2015-12

Locations