Assessment of the Burden Within the Dyad Patient/Caregiver

Palliative Care Clinical Trial

— RAPSODIE  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00921232
• Other study ID #: RAPSODIE
• Status: Completed
• Phase: N/A
• First received: May 29, 2009
• Last updated: July 20, 2012
• Start date: April 2007
• Est. completion date: February 2008

Study information

• Verified date: July 2012
• Source: Centre Oscar Lambret
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Direction Générale de la Santé
• Study type: Interventional

Clinical Trial 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)

Other known NCT identifiers

• NCT00958594

Recruitment information / eligibility

• Status: Completed
• Enrollment: 139
• Est. completion date: February 2008
• Est. primary completion date: February 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Palliative Care

Intervention

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

Locations

Country	Name	City	State
France	Centre Oscar Lambret	Lille

Sponsors (3)

Lead Sponsor	Collaborator
Centre Oscar Lambret	Unité de REcherche en sciences Cognitives et Affectives URECA EA1059, University of Lille Nord de France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	Search for factors influencing the return at home of the life-ending patients by statistic analysis		Death	No