Abstract
BackgroundDespite its proven efficacy in reducing recurrence and improving survival, adherence to endocrine therapy (ET) is suboptimal in women with breast cancer (BC). Health-related quality of life (HRQoL) in BC has been widely studied and many positive effects have been highlighted. Recently, a link between HRQoL and compliance with ET has been suggested, which would suggest a potential role for HRQoL assessment in improving compliance with ET. With the advent of digital technologies, electronic collection of HRQoL on a tablet is now possible. Thus, we hypothesize that systematic HRQoL assessment (using a tablet, prior to each consultation, with presentation of scores to clinicians) coupled with therapeutic information could have an impact on 12-month compliance with ET in patients with non-metastatic BC.MethodsIn this study, we will include 342 women with non-metastatic hormone receptor–positive BC with an indication for treatment with ET. Patients will be randomly assigned 1:1 by minimization and stratified by age, stage, type of ET prescribed, and presence of comorbidities (or not) in two arms. The intervention will consist of numerical HRQoL assessment using the CHES (Computer-based Health Evaluation System) software before each consultation (with delivery of scores to clinicians) coupled with therapeutic information. Therapeutic information will consist of three workshops related to understanding the prescription, nutrition, and fatigue. A reminder letter will be sent to patients every month. Patients in the control group will follow standard care. HRQoL will be assessed using a classic “paper-pencil” collection at baseline in both arms to ensure comparability between arms and at 12 months. The primary endpoint is 12-month compliance with ET. Patient satisfaction with care and the clinicians’ perception of the usefulness of routine HRQoL assessment will also be assessed.DiscussionThis study will allow clinicians to identify and better understand the areas in which patients who receive ET have difficulties and thus it will assist clinicians with patient management. Systematic evaluation of HRQoL could provide an additional endpoint for measuring patients’ health status and treatment-related symptoms, including ET. If the results of this study are positive, this intervention could be proposed as an integral part of daily clinical practice in patients who receive ET.Trial registrationClinicalTrials.govNCT04176809. Registered Nov. 25, 2019.
Highlights
Despite its proven efficacy in reducing recurrence and improving survival, adherence to endocrine therapy (ET) is suboptimal in women with breast cancer (BC)
If the results of this study are positive, this intervention could be proposed as an integral part of daily clinical practice in patients who receive ET
This study has shown that education materials do not improve compliance in this patient population and has highlighted the complex nature of compliance and persistence [12]
Summary
Despite its proven efficacy in reducing recurrence and improving survival, adherence to endocrine therapy (ET) is suboptimal in women with breast cancer (BC). We hypothesize that systematic HRQoL assessment (using a tablet, prior to each consultation, with presentation of scores to clinicians) coupled with therapeutic information could have an impact on 12-month compliance with ET in patients with non-metastatic BC. A large number of hormonal and cytotoxic oral therapies are available for breast cancer (BC) management. In cancer treatment, more than 40 oral drug specialties are reimbursed by the French health insurance system [1]. These oral forms present a new challenge in oncology, namely concerning treatment compliance. Oral anticancer therapies raise concerns about poor compliance, the impact of adverse effects due to non-compliance on clinical outcomes. Noncompliance compromises overall efficacy of oral therapies and potentially leads to treatment failure [4]
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