Cost-effectiveness of the ONCORAL multidisciplinary programme for the management of outpatients taking oral anticancer agents at risk of drug-related event: protocol for a pragmatic randomised controlled study - Archive ouverte HAL Accéder directement au contenu
Article Dans Une Revue BMJ Open Année : 2024

Cost-effectiveness of the ONCORAL multidisciplinary programme for the management of outpatients taking oral anticancer agents at risk of drug-related event: protocol for a pragmatic randomised controlled study

Laure Huot
Pascale Guerre
Guillaume Descotes
  • Fonction : Auteur
Anne-Gaëlle Caffin
  • Fonction : Auteur
Chloé Herledan
  • Fonction : Auteur
Florence Ranchon
  • Fonction : Auteur
Catherine Rioufol
  • Fonction : Auteur
  • PersonId : 1354780

Résumé

Introduction The development of oral anticancer agents (OAA) has profoundly changed cancer care, leading patients to manage their chemotherapy treatment on an outpatient basis. The prevention of iatrogenic effects of OAA remains a major concern, especially since their side effects are not less serious than those of intravenous chemotherapy. The ONCORAL programme was set up to secure the management of OAA in cancer patients followed at the Lyon University Hospital. This multidisciplinary programme involves hospital pharmacists, nurses, oncologists, and haematologists, as well as community health professionals. Given the economic stakes that this programme entails for the health system, a medico-economic study was designed. Methods and analysis This is a prospective controlled study, with individual open-label randomisation. A total of 216 outpatients treated with OAA and at risk of developing a drug-related iatrogenic event, will be randomised (2:1) to undergo follow-up in the ONCORAL programme or usual care. The primary outcome will be the estimation of the incremental cost-effectiveness ratio (difference in total costs per quality adjusted life years gained) at 12 months between the two groups. The secondary outcomes will be evaluation of OAA management consequences (relativedose intensity, adherence, adverse drug events, drug-drug interactions, and proven medication errors), evaluation of overall survival and cancer-related quality of life, and patient-reported outcomes in relation to the treatment. A budget impact analysis will be implemented. Patient and health professional satisfaction regarding the ONCORAL programme will be measured. Ethics and dissemination Approval to conduct this study was obtained from an Ethics Committee (Comité de Protection des Personnes Ile-de-France VI) in October 2019, and from the French data protection agency (Commission Nationale de l'Informatique et des Libertés), according to the French Law. Trial results will be disseminated at clinical conferences and published in peer-reviewed journals. Trial registration NCT03660670.
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hal-04468476 , version 1 (20-02-2024)

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Laure Huot, Pascale Guerre, Guillaume Descotes, Anne-Gaëlle Caffin, Chloé Herledan, et al.. Cost-effectiveness of the ONCORAL multidisciplinary programme for the management of outpatients taking oral anticancer agents at risk of drug-related event: protocol for a pragmatic randomised controlled study. BMJ Open, 2024, 14, ⟨10.1136/bmjopen-2023-074956⟩. ⟨hal-04468476⟩

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