Cancer End Of Life Evaluation (CEOLE)

Institut Cancerologie de l'Ouest

Status: Terminated

Conditions: Advanced Cancer

Treatments: Other: Quality Of Life questionnaires completion

Study type: Interventional

Funder types: Other

Identifiers

NCT01545921

CPP-435

2010-A00196-33 (Other Identifier)

Details and patient eligibility

About

The aim of this study is to culturally adapt and to validate Quality Of Life tools dedicated to the end of life for French cancer patients.

Full description

French clinical research in palliative care is confronted with a lack of tools allowing to estimate in a standardized way a patient related outcome. Scales used today are not specifically adapted to quality of life (QoL) at the end of life patient evaluation. So all the relative dimensions to this disease stage are not estimated. What establishes a brake in the improvement of a quality support.

The dimensions of pain, psychological distress, fatigue, decrease of the autonomy are essential points estimated in "classic" questionnaires and frequently used at the palliative disease stage. However the end of life also recovers the domains of the spirituality, oneself's completion, relationship. These elements are essential to dread better QoL at end of life, but are not or do not little approach on the French questionnaires.

The Missoula-Vitas Quality Of Life Index is a questionnaire developed by Byock, Merriman and Kinzbrunner and specifically designed for palliative situations [I. Byock, 1998]. This QoL tool provides an exhaustive assessment of important dimensions in this setting. The short version is composed of 15 items and asks patients to evaluate 5 dimensions: symptoms, function, interpersonal relationships, well-being and transcendence [I. Byock, 1998].

Another tool, the QUAL-E, is longer with 25 items concerning 5 domains: life completion, relations with the health care system, preparation for end of life, symptom severity and affective social support [KE. Steinhauser, 2002]. However, these QoL tools have not been translated and adapted to French. Another concern is that the lack of specificity for cancer patients.

The first step to improve evaluation of how French patients feel about this phase of their disease is to translate these specific end of life QoL tools. Assessing QoL at the end of life with dedicated tools could help to compare therapeutic strategies and could result in improvements in palliative care.

Enrollment: 179 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Palliative advanced cancer patient (Palliative chemotherapy, analgesic radiotherapy, surgery of comfort accepted).
• All cancer locations and cancer type
• Patient having the knowledge of their palliative disease stage.
• Patient follow-up at least once a month by a palliative caregiver.
• Age > or = 18 years.
• Dated and signed consent.
• PS > or = 2
• Life expectation > or = 1 month.

Exclusion criteria

• Psychiatric Disease or cognitive disorders disrupting the trial understanding and the enlightened and voluntary consent character.
• Patient who can not submit itself to the formal follow-up for psychological, social, family or geographical reasons

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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179 participants in 4 patient groups

Arm A

Experimental group

Description:

Patients will complete QoL questionnaires in the following order : MVQOLI, then QLQ-C15-PAL, then QUAL-E, evaluation every month until death

Treatment:

Other: Quality Of Life questionnaires completion

Arm B

Experimental group

Description:

Patients will complete QoL questionnaires in the following order : QLQ-C15-PAL, then MVQOLI, then QUAL-E, evaluation every month until death

Treatment:

Other: Quality Of Life questionnaires completion

Arm C

Experimental group

Description:

Patients will complete QoL questionnaires in the following order : MVQOLI, then QLQ-C15-PAL, then QUAL-E, evaluation every month and spontaneous QoL completion, until death

Treatment:

Other: Quality Of Life questionnaires completion

Arm D

Experimental group

Description:

Patients will complete QoL questionnaires in the following order : QLQ-C15-PAL, then MVQOLI, then QUAL-E, evaluation every month and spontaneous QoL completion, until death.

Treatment:

Other: Quality Of Life questionnaires completion