Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2024 Feb 17;14(2):e074956.
doi: 10.1136/bmjopen-2023-074956.

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  1   2 , Pascale Guerre  1   3 , Guillaume Descotes  4 , Anne-Gaëlle Caffin  4 , Chloé Herledan  4   5 , Florence Ranchon #  4   5 , Catherine Rioufol #  6   5
Affiliations

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 et al. BMJ Open. .

Abstract

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 (relative-dose 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.

Keywords: Adult oncology; Health economics; Quality of Life.

PubMed Disclaimer

Conflict of interest statement

Competing interests: None declared.

Similar articles

See all similar articles

Cited by

References

    1. Kantarjian H, O’Brien S, Jabbour E, et al. . Improved survival in chronic myeloid leukemia since the introduction of imatinib therapy: a single-institution historical experience. Blood 2012;119:1981–7. 10.1182/blood-2011-08-358135 - DOI - PMC - PubMed
    1. Eek D, Krohe M, Mazar I, et al. . Patient-reported preferences for oral versus intravenous administration for the treatment of cancer: a review of the literature. Patient Prefer Adherence 2016;10:1609–21. 10.2147/PPA.S106629 - DOI - PMC - PubMed
    1. Mc Laughlin AM, Schmulenson E, Teplytska O, et al. . Developing a nationwide infrastructure for therapeutic drug monitoring of targeted oral anticancer drugs: the ON-TARGET study protocol. Cancers (Basel) 2021;13:6281. 10.3390/cancers13246281 - DOI - PMC - PubMed
    1. O’Neill VJ, Twelves CJ. Oral cancer treatment: developments in chemotherapy and beyond. Br J Cancer 2002;87:933–7. 10.1038/sj.bjc.6600591 - DOI - PMC - PubMed
    1. Johnson TaliM. Long-term care: safe drug handling of oral chemotherapy. Consult Pharm 2017;32:74–83. 10.4140/TCP.n.2017.74 - DOI - PubMed

Publication types

Substances

Associated data

LinkOut - more resources