NCT00921232

Brief Summary

This study is about the patients life ending and their caregiver, when a return to home is planned. This is a behavioral sciences study (= interventional study for french law)

Trial Health

87
On Track

Trial Health Score

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

Enrollment
139

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2007

Shorter than P25 for not_applicable

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

April 1, 2007

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2008

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

May 29, 2009

Completed
18 days until next milestone

First Posted

Study publicly available on registry

June 16, 2009

Completed
Last Updated

March 16, 2026

Status Verified

March 1, 2026

Enrollment Period

10 months

First QC Date

May 29, 2009

Last Update Submit

March 12, 2026

Conditions

Palliative Care

Keywords

Life-ending patientcaregiver

Outcome Measures

Primary Outcomes (1)

  • Caregiver Reaction Assessment (CRA scale) completed by patient (hetero-perception) and its caregiver (auto-perception)

    At baseline, to the announcement of the exclusive palliative care

Secondary Outcomes (2)

  • Perception of the burden by the patient and its caregiver: search for potential predictive factors of the burden by statistic analysis HADS (The Hospital Anxiety and Depression Scale FRI (The Family Relationship Index)

    At baseline, to the announcement of the exclusive palliative care

  • Search for factors influencing the return at home of the life-ending patients by statistic analysis

    Death

Study Arms (1)

dyad

OTHER

life-ending patient and its caregiver

Behavioral: Questionnaires

Interventions

QuestionnairesBEHAVIORAL

During a consultation: * 3 questionnaires (HADS, FRI, CRA) * and a form for the sociodemographic data

dyad

Eligibility Criteria

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

You may qualify if:

  • Patient \> 18 years old
  • Cancer for which no curative treatment is envisaged
  • Palliative treatment only
  • For the caregiver: designated by the patient like the referring individual

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre Oscar Lambret

Lille, 59020, France

Location

MeSH Terms

Interventions

Surveys and Questionnaires

Intervention Hierarchy (Ancestors)

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

Study Officials

  • Nicolas PENEL, MD

    Centre Oscar Lambret

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

May 29, 2009

First Posted

June 16, 2009

Study Start

April 1, 2007

Primary Completion

February 1, 2008

Study Completion

February 1, 2008

Last Updated

March 16, 2026

Record last verified: 2026-03

Locations

FR(1)