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Multicenter randomized effectiveness/implementation trial of a digital self-management support tool to improve the quality of life during adjuvant hormonal therapy for patients with early breast cancer: The HOPE trial.

Maria Alice Franzoi·Stefan Michels·Sarah Ball·Aude Barbier·Chloe Serhal·Alicia Bernatowiez·Arlindo Ferreira·Juliete Fanton D'Andon·Francois Gernier·Adeline Morel·Julie Demetz·Fanny Le Du·Pietro Lapidari·Ines Vaz-Luis
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Abstract

BACKGROUND: For patients with hormone receptor (HR) positive early breast cancer (BC), adjuvant endocrine therapy (ET) represents the cornerstone of treatment. However, 75% of patients experience ET-related symptoms that negatively affect their quality of life (QOL). Despite their high prevalence, these symptoms are often underestimated and under-addressed during consultations. As a result, non-adherence to ET is common and remains a major barrier for optimal disease and survival outcomes. METHODS: National, prospective, randomized, open-label hybrid type 1 effectiveness/implementation trial conducted in France comparing a personalized digital health pathway plus standard of care (SoC) vs. SoC alone in patients with HR+ early BC reporting ET-related symptoms. 180 patients will be randomized 1:1 to receive either 12 weeks of the digital health pathway or 12 weeks of SoC. The intervention is anchored by the Resilience© digital companion including remote symptom and needs assessment, an introductory nurse-navigator phone call, and access to personalized, symptom-specific online educational and self-management programs (physical activity, yoga, meditation or cognitive behavioral therapy). In both arms, patients will be invited to wear a wearable device to objectively monitor behavioral parameters. The primary endpoint is the ET symptoms scale of the European Organization for Research and Treatment of Cancer (EORTC) QLQ-BR45 over 12-weeks. Secondary endpoints include other QOL domains, self-reported ET adherence, eHealth literacy, self-efficacy, and evaluation of the implementation process. DISCUSSION: This study should provide evidence on the effectiveness and real-world implementation of a personalized digital health pathway to improve QOL in patients experiencing ET-related symptoms. TRIAL REGISTRATION: ClinicalTrials.gov NCT06781996; Protocol version 3.0.

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HumansBreast NeoplasmsFemaleQuality of LifeSelf-ManagementDigital HealthProspective StudiesAntineoplastic Agents, HormonalFranceChemotherapy, AdjuvantAdultMiddle AgedAdjuvant endocrine therapyDigital healthEarly breast cancerNurse navigationQuality of lifeSelfmanagement supportJournal ArticleRandomized Controlled TrialMulticenter Study

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Maria Alice Franzoi, Stefan Michels, Sarah Ball, Aude Barbier, Chloe Serhal, Alicia Bernatowiez, Arlindo Ferreira, Juliete Fanton D'Andon, Francois Gernier, Adeline Morel, Julie Demetz, Fanny Le Du, Pietro Lapidari, Ines Vaz-Luis. 2026-07-25. Multicenter randomized effectiveness/implementation trial of a digital self-management support tool to improve the quality of life during adjuvant hormonal therapy for patients with early breast cancer: The HOPE trial.. https://doi.org/10.1016/j.cct.2026.108407

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