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Assessment of the Burden Within the Dyad Patient/Caregiver (RAPSODIE)

This study has been completed.
Sponsor:
Collaborators:
Unité de REcherche en sciences Cognitives et Affectives URECA EA1059
Université Lille Nord de France - Université de Lille 3
Information provided by (Responsible Party):
Centre Oscar Lambret
ClinicalTrials.gov Identifier:
NCT00921232
First received: May 29, 2009
Last updated: July 20, 2012
Last verified: July 2012
History of Changes
  Purpose

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)


Condition Intervention
Palliative Care
 Behavioral: Questionnaires

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: Crossed Assessment of the Burden Within the Dyad Patient/Caregiver: Analysis of Explanatory Factors and Consequences for Return at Home of the Life-ending Patient

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Centre Oscar Lambret:

Primary Outcome Measures:
  • Caregiver Reaction Assessment (CRA scale) completed by patient (hetero-perception) and its caregiver (auto-perception) [ Time Frame: At baseline, to the announcement of the exclusive palliative care ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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) [ Time Frame: At baseline, to the announcement of the exclusive palliative care ] [ Designated as safety issue: No ]
  • Search for factors influencing the return at home of the life-ending patients by statistic analysis [ Time Frame: Death ] [ Designated as safety issue: No ]

Enrollment: 139
Study Start Date: April 2007
Study Completion Date: February 2008
Primary Completion Date: February 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
dyad
life-ending patient and its caregiver
 Behavioral: Questionnaires

During a consultation:

  • 3 questionnaires (HADS, FRI, CRA)
  • and a form for the sociodemographic data

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00921232

Locations
France
Centre Oscar Lambret
Lille, France, 59020
Sponsors and Collaborators
Centre Oscar Lambret
Unité de REcherche en sciences Cognitives et Affectives URECA EA1059
Université Lille Nord de France - Université de Lille 3
Investigators
Principal Investigator: Nicolas PENEL, MD Centre Oscar Lambret
  More Information

No publications provided

Responsible Party: Centre Oscar Lambret
ClinicalTrials.gov Identifier: NCT00921232     History of Changes
Obsolete Identifiers: NCT00958594
Other Study ID Numbers: RAPSODIE
Study First Received: May 29, 2009
Last Updated: July 20, 2012
Health Authority: France: Direction Générale de la Santé

Keywords provided by Centre Oscar Lambret:
Life-ending patient
caregiver

ClinicalTrials.gov processed this record on May 23, 2013