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).

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.

Conditions for the Implementation of a Patient Education Program Dedicated to Cancer Patients Treated by Oral Anticancer Therapy.

INTRODUCTION: A patient education program has been developed in the field of cancer for supporting cancer patients undergoing oral anticancer therapies. Its implementation was tested in 3 different settings. The objectives of this study were to 1) identify barriers and facilitators for implementing the patient education program, 2) identify practices encouraging or hindering implementation and 3) produce recommendations for its dissemination. METHODS: Twenty semi-structured interviews were conducted with caregivers from all three establishments. RESULTS: The main factors associated with successful implementation were as follows: prescribers' representations on patient education, considered of low value; on oral anticancer therapies, considered too dangerous to be handled by the patient him/herself, the indefinite legitimacy of certain professions in charge of patient education programs; patients' engagement in their care pathway and provision of caregivers. CONCLUSION: Recommendations include developing patient education culture within the environment of the medical doctors' curriculum, to consider contextual, pre-existing cooperative units for implementing patient education, to systematically send patients to patient education programs without practicing triage. Successful implementation of patient education critically depends on the prescribing physicians' perceived value of patient education. Patient education should become mandatory, integrated as part of the cancer care pathway. Physicians lack the necessary time and/or means to assess patients' capacity for engagement, without adequate strategies for their support. Therefore, physicians should systematically refer all patients to patient education, where nurses can tailor their coaching of cancer patients. TRIAL REGISTRATION: The study protocol was approved by the IRB SUD EST I (N° EudraCT: 2016-A00113-48). All participants were given written and verbal information about the study and gave informed consent to participate.