Medical Oncology Department, Lucien Neuwirth Cancer Institute, 108 bis Avenue Albert Raimond, 42270, Saint Priest en Jarez, France.
Oncology Department, Loire Private Hospital, 42000, Saint Etienne, France.
Support Care Cancer. 2021 Aug;29(8):4257-4267. doi: 10.1007/s00520-020-05955-3. Epub 2021 Jan 7.
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.
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.
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.
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.
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.
在过去的二十年中，口服癌症药物（OAD）的使用有所增加。本研究的目的是衡量护士主导的电话随访在接受 OAD 治疗的患者的治疗管理中的作用，以评估毒性、药物依从性和生活质量。
进行了一项随机、多中心、对照试验。所有年龄在 18 岁以上的连续患者，在肿瘤内科、放疗科或血液科接受 OAD 治疗的任何癌症患者，均被邀请参加该研究。共有 183 名接受实体瘤或血液系统癌症 OAD 治疗的患者被随机分配接受护士主导的电话随访或标准护理 24 周。数据收集于 2015 年至 2018 年期间。
护士电话随访并未改善干预组的总体毒性评分。然而，经过培训的护士进行的电话随访显著减少了整个随访期间 3 级不良事件的患者数量[比值比 0.45（95%可信区间）（0.23，0.9）]（P = 0.03）。在任何随访时间点，两组的生活质量和药物依从性均无显著差异。
在这项法国真实世界的首次研究中，合格护士通过电话提供的建议改善了 3 级毒性的管理，但未能证明所有级别毒性的改善。需要更多的前瞻性研究来证实电话通话对 OAD 相关毒性的影响。
临床试验注册号为 NCT02459483。SUD-ESTI 保护委员会注册号为 2015-A00527-42，于 2015 年 4 月 13 日注册。国家药品监督管理局注册号为 150619-B，于 2015 年 5 月 27 日注册。
