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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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 November 20, 2014