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Clinical Trials/NCT01545921
NCT01545921
Terminated
N/A

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

Institut Cancerologie de l'Ouest10 sites in 1 country179 target enrollmentNovember 11, 2011
ConditionsAdvanced Cancer

Overview

Phase
N/A
Intervention
Not specified
Conditions
Advanced Cancer
Sponsor
Institut Cancerologie de l'Ouest
Enrollment
179
Locations
10
Primary Endpoint
Psychometric validation of QUALE and Missoula Vitas Quality Of Life Index (MVQOLI)
Status
Terminated
Last Updated
2 years ago

Overview

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, 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.

Registry
clinicaltrials.gov
Start Date
November 11, 2011
End Date
June 6, 2019
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Institut Cancerologie de l'Ouest
Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

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)

Secondary Outcomes

  • Change in Quality of Life at different times(Up to 3 years)
  • Number of spontaneous questionnaire completions(Up to 3 years)
  • Rate of completion(Up to 3 years)

Study Sites (10)

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