Cancer End Of Life Evaluation (CEOLE)

July 31, 2023 updated by: Institut Cancerologie de l'Ouest

Evaluation and Validation of Quality Of Life Scales in Palliative Advanced Cancer

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

179

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Angers, France, 49933
        • ICO Paul Papin
      • Angers, France, 49933
        • CHU
      • Besançon, France, 25030
        • CHU Minjoz
      • Bordeaux, France, 33076
        • Institut Bergonie
      • Cholet, France, 49325
        • Centre Hospitalier
      • Dijon, France, 21079
        • Centre Georges Francois Leclerc
      • Lille, France, 59020
        • Centre Oscar Lambret
      • Montpellier, France, 34298
        • Centre Val d'Aurelle Paul Lamarque
      • Nice, France, 06189
        • Centre Antoine Lacassagne
      • Vandoeuvre les Nancy, France, 54511
        • Centre Alexis Vautrin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm A

Patients will complete QoL questionnaires in the following order :

MVQOLI, then QLQ-C15-PAL, then QUAL-E, evaluation every month until death
Other: Quality Of Life questionnaires completion

Before randomization, all patients will have to complete questionnaires in this order : QLQ-C15-PAL, MVQOLI and QUAL-E.

MVQOLI and QUAL-E will be completed again 3 days after the first completion at baseline. After this second QoL assessment, the order will be modified according to patient's randomisation : arm A, B, C or D.
Experimental: Arm B

Patients will complete QoL questionnaires in the following order :

QLQ-C15-PAL, then MVQOLI, then QUAL-E, evaluation every month until death
Other: Quality Of Life questionnaires completion

Before randomization, all patients will have to complete questionnaires in this order : QLQ-C15-PAL, MVQOLI and QUAL-E.

MVQOLI and QUAL-E will be completed again 3 days after the first completion at baseline. After this second QoL assessment, the order will be modified according to patient's randomisation : arm A, B, C or D.
Experimental: Arm C

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
Other: Quality Of Life questionnaires completion

Before randomization, all patients will have to complete questionnaires in this order : QLQ-C15-PAL, MVQOLI and QUAL-E.

MVQOLI and QUAL-E will be completed again 3 days after the first completion at baseline. After this second QoL assessment, the order will be modified according to patient's randomisation : arm A, B, C or D.
Experimental: Arm D

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.
Other: Quality Of Life questionnaires completion

Before randomization, all patients will have to complete questionnaires in this order : QLQ-C15-PAL, MVQOLI and QUAL-E.

MVQOLI and QUAL-E will be completed again 3 days after the first completion at baseline. After this second QoL assessment, the order will be modified according to patient's randomisation : arm A, B, C or D.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Psychometric validation of QUALE and Missoula Vitas Quality Of Life Index (MVQOLI)
Time Frame: Up to 3 years

Both QUALE and MVQOLI have many questions, and each question is evaluated by a number of points. At the end of completion, a score is calculated thanks to number of points and is used to compare the different times completion :

  • no change of score between the 2 first completion (reproductibility)
  • change score with baseline
  • correlation with QLQ-C15 PAL Score
  • correlation with clinical measure (PS, PPS)
Up to 3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Quality of Life at different times
Time Frame: Up to 3 years
Every month or more, QUALE, MVQOLI and QLQ-C15-PAL will be completed by patient, a final score will be calculated and compared at different times.
Up to 3 years
Number of spontaneous questionnaire completions
Time Frame: Up to 3 years
In arms C and D, patients can complete QLQ-C15-PAL and MVQOLI questionnaires at home if they need it. The number of spontaneous questionnaires completions will be evaluated and the impact on quality of life assessed thanks to calculated score.
Up to 3 years
Rate of completion
Time Frame: Up to 3 years
Every month or more, the 3 questionnaires QUALE, MVQOLI and QLQ-C15-PAL have to be completed by patient. The rate of completion will be calculated.
Up to 3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institut Cancerologie de l'Ouest

Investigators

  • Principal Investigator: Jean-Marie Commer, MD, Institut Cancerologie de l'Ouest

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 11, 2011

Primary Completion (Actual)

June 6, 2019

Study Completion (Actual)

June 6, 2019

Study Registration Dates

First Submitted

March 16, 2011

First Submitted That Met QC Criteria

March 6, 2012

First Posted (Estimated)

March 7, 2012

Study Record Updates

Last Update Posted (Actual)

August 1, 2023

Last Update Submitted That Met QC Criteria

July 31, 2023

Last Verified

November 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CPP-435
  • 2010-A00196-33 (Other Identifier: French Health Products Safety Agency)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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