Cancer End Of Life Evaluation

Advanced Cancer Clinical Trial

— CEOLE  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01545921
• Other study ID #: CPP-435
• Secondary ID: 2010-A00196-33
• Status: Terminated
• Phase: N/A
• Start date: November 11, 2011
• Est. completion date: June 6, 2019

Study information

• Verified date: November 2020
• Source: Institut Cancerologie de l'Ouest
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 179
• Est. completion date: June 6, 2019
• Est. primary completion date: June 6, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Advanced Cancer
• Neoplasms

Intervention

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.

Locations

Country	Name	City	State
France	CHU	Angers
France	ICO Paul Papin	Angers
France	CHU Minjoz	Besançon
France	Institut Bergonié	Bordeaux
France	Centre Hospitalier	Cholet
France	Centre Georges François Leclerc	Dijon
France	Centre Oscar Lambret	Lille
France	Centre Val d'Aurelle Paul Lamarque	Montpellier
France	Centre Antoine Lacassagne	Nice
France	Centre Alexis Vautrin	Vandoeuvre les Nancy

Sponsors (1)

Lead Sponsor	Collaborator
Institut Cancerologie de l'Ouest

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Psychometric validation of QUALE and Missoula Vitas Quality Of Life Index (MVQOLI)	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	Change in Quality of Life at different times	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
Secondary	Number of spontaneous questionnaire completions	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
Secondary	Rate of completion	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

External Links

•   Sponsor Information