Oncologie

, Volume 19, Issue 1–2, pp 3–9 | Cite as

Spécificités et recherches méthodologiques pour l’évaluation en soins de support en oncologie

  • M. -J. Paillard
  • M. Pulido
  • J. -P. Metges
  • T. Almont
  • N. Heutte
  • F. Bonnetain
Mise au Point / Update
  • 53 Downloads

Résumé

Les soins de support (SS) [médicamenteux ou non médicamenteux] ont une place de plus en plus importante dans l’arsenal de prise en charge holistique des patients ayant un cancer. À ce titre, l’évaluation de l’efficacité de ces interventions médicamenteuses ou non doit reposer sur des études cliniques développées selon une méthodologie optimale à l’instar des traitements dits curatifs. L’un des freins au développement de SS non médicamenteux consiste en l’évaluation méthodologique de leur efficacité, mais de façon similaire à ce que l’on observe dans le processus du développement du médicament: de la phase I à la phase III. La question de l’évaluation conjointe des SS et des traitements potentiellement curatifs est également une approche méthodologique à investiguer afin d’étudier les interactions et proposer, si besoin, une prise en charge adaptée propre à optimiser l’efficacité des traitements. À ce jour, il n’existe pas de guidelines spécifiques en cancérologie pour l’évaluation des SS. La complexité de la méthodologie requise pour mener à bien des études d’évaluation nécessite une réflexion et l’élaboration d’un cadre structuré de type CONSORT stands for Consolidated Standards of Reporting Trials ainsi qu’une collaboration multidisciplinaire impliquant également les patients.

Mots clés

Critère de jugement Essais cliniques Méthodologie Recommandations Soins de support 

Specificities and methodological research to assess supportive care in oncology

Abstract

Supportive care (pharmacological or non-pharmacological) has a key role in promoting holistic care of cancer patients. As such, the evaluation of the effectiveness of pharmacological or non-pharmacological interventions should be based on clinical trials designed with optimal methodology like it was developed for the curative treatment. One of the binding limitations to the development of non-pharmacological supportive care is the assessment of their efficacy. It should be done in steps similar to the pharmacological development process: From Phase I to Phase III. The question of joint assessment of supportive care and potentially curative treatment is also a key methodological challenge needing to be investigated to study the interactions. Based on such a study, we will be able to offer personalized care to optimize treatment efficacy. Actually, there is no specific cancer guideline for the evaluation of supportive care. The complexity of the methodology required to carry out process to investigate the development of a dedicated structured framework as it was done with CONSORT and a multi-disciplinary partnership also involving patients.

Keywords

Outcome measure Clinical trials Methodology Recommendations Supportive care 

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Copyright information

© Lavoisier 2017

Authors and Affiliations

  • M. -J. Paillard
    • 1
    • 2
  • M. Pulido
    • 3
  • J. -P. Metges
    • 4
  • T. Almont
    • 5
  • N. Heutte
    • 6
    • 7
  • F. Bonnetain
    • 1
  1. 1.Methodology and Quality of Life in Oncology Unit (Inserm UMR 1098)National Quality of Life and Cancer Clinical Research Platform, CHUBesançonFrance
  2. 2.Department of Medical OncologyUniversity Hospital of BesançonBesançonFrance
  3. 3.Clinical and Epidemiological Research UnitBergonié Cancer InstituteBordeauxFrance
  4. 4.Oncology & Haematology InstituteBrest University HospitalBrestFrance
  5. 5.EA3694 Human Fertility Research GroupCHU Paule-de-Viguier, TSA 70034Toulouse cedex 09France
  6. 6.CETAPS - UFR STAPS - Université de Rouen - Bd SiegfriedMont Saint Aignan cedexFrance
  7. 7.Service de Recherche CliniqueCentre François BaclesseCaen Cedex 05France

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