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Effectiveness of a nurse-led telephone follow-up in the therapeutic management of patients receiving oral antineoplastic agents: a randomized, multicenter controlled trial (ETICCO study)

Abstract

Purpose

The use of oral cancer drugs (OAD) has increased over the last two decades. The objective of this study was to measure the impact of a nurse-led telephone follow-up in the therapeutic management of patients treated with an OAD regarding toxicity, medication adherence and quality of life.

Methods

A randomized, multicenter, controlled trial was conducted. All consecutive over 18-year-old patients, treated in medical oncology, radiotherapy, or hematology departments, receiving OAD for any cancer were invited to participate to the study. A total of 183 patients treated for solid or hematological cancers with an OAD were randomly assigned to receive a nurse-led telephone follow-up or standard care for 24 weeks. Data were collected between 2015 and 2018.

Results

Nurse telephone follow-up did not improve the global score toxicity in the intervention group. However, telephone calls directed by trained nurses induced a significant decrease in number of patients with grade 3 adverse events throughout the follow-up [OR 0.45 (IC à 95%) (0.23, 0.9)](P = 0.03). There was no significant difference in quality of life and medication adherence between groups at any follow-up time point.

Conclusions

In this first French real-life study, the advice provided by qualified nurses via phone calls improved the management of grade 3 toxicities but failed to demonstrate an improvement of all grades of toxicities. More prospective studies are needed to confirm the impact of telephone calls on the toxicities related to OAD.

Trial registration

Clinical trial registration is NCT02459483.

Protection committee SUD-ESTI registration is 2015-A00527-42 on 13 April 2015. National Agency for the Safety of Medicines and Health Products registration is 150619-B on the 27 may 2015.

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Data availability

All data are available on request.

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Acknowledgments

The authors gratefully acknowledges all pivot nurses of Lucien Neuwirth Cancer Institute for their help and involvement in this study.

The authors gratefully acknowledges the funding agencies, as well as Mr. Eric- Alban Giroux, the investigators, the collaborators, the medical and paramedical nurses, and all clinical research associates.

The authors would like to thank Miss Sandrine Sotton for English editing services.

Funding

This study was supported by “Le réseau espace santé cancer Rhones-Alpes: INNOV’RA 2014”, “La ligue contre le cancer” and “Novartis Pharma SAS” and the financial support of the Institute of Cancerology Lucien Neuwirth; no grant number is applicable.

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Authors

Contributions

Conceptualization, Mathieu Oriol; Aurélie Bourmaud; Cécile Vassal; Methodology, Mathieu Oriol; Aurélie Bourmaud; Cécile Vassal; Fabien Tinquaut; Software, Sidonie Pupier; Validation, Cécile Vassal; Wafa Bouleftour; Fabien Tinquaut; Formal Analysis, Wafa Bouleftour; Fabien Tinquaut; Cécile Vassal; Investigation, Thierry Muron; Aline Guillot; Romain Rivoirard; Jean-Philippe Jacquin; Léa Saban-Roche; Karima Boussoualim; Emmanuelle Tavernier; Karine Augeul-Meunier; Olivier Collard; Benoite Mery; Pierre Fournel; Writing—Original Draft Preparation, Wafa Bouleftour; Writing—Review and Editing, all authors

Corresponding author

Correspondence to Wafa Bouleftour.

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Conflict of interest/Competing interests

The authors declare that they have no conflicts of interest.

Ethics approval

All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards.

Consent to participate

Informed consent was obtained from all individual participants included in the study.

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All the authors gave their consent for the publication of this work.

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Appendix

Appendix

Fig. 6
figure6

Diagram of the trial. (A) Schematic image of the progress of ETICCO study. V: represents medical visits and C: represents the telephone calls. (B) Study flow chart

Fig. 7
figure7

(A) Time to Treatment Failure and (B) Overall survival

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Bouleftour, W., Muron, T., Guillot, A. et al. Effectiveness of a nurse-led telephone follow-up in the therapeutic management of patients receiving oral antineoplastic agents: a randomized, multicenter controlled trial (ETICCO study). Support Care Cancer 29, 4257–4267 (2021). https://doi.org/10.1007/s00520-020-05955-3

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Keywords

  • Oral antineoplastic drugs
  • Education of patients
  • Side-effect prevention
  • Safety monitoring
  • Telephone