Ignite Creation Date:
2024-05-06 @ 12:19 AM
Last Modification Date:
2024-10-26 @ 10:48 AM
Study NCT ID:
NCT01545921
Status:
TERMINATED
Last Update Posted:
2023-08-01
First Post:
2011-03-16
Brief Title:
Cancer End Of Life Evaluation
Sponsor:
Institut Cancerologie de lOuest
Organization:
Institut Cancerologie de lOuest
Study Overview
Official Title:
Evaluation and Validation of Quality Of Life Scales in Palliative Advanced Cancer
Status:
TERMINATED
Status Verified Date:
2020-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
End of inclusions without reaching the expected number of patients
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CEOLE
Brief 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
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 oneselfs 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
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 oneselfs 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2010-A00196-33 | OTHER | French Health Products Safety Agency | None |