Interactive symptom monitoring and coaching to optimise toxicity management of chemo(immune)therapy in early stage breast cancer: study protocol of the multicentre randomised controlled eChemoCoach trial

Background: Several studies have demonstrated the efficacy of electronic patient-reported outcomes (ePROs) monitoring during chemo(immune)therapy, improving symptom detection and health-related quality of life (HRQoL). However, most existing applications only alert caregivers when patients report severe toxicity and lack real-time, symptom specific feedback for mild to moderate symptoms. This may undermine self-management, missing the opportunity to prevent progression to more severe toxicity. Integration of triage questions in ePRO symptom management enables the generation of tailored severity-based advice and facilitates timely self-directed care, minimising involvement of caregivers for mild symptoms. This study aims to evaluate whether symptom monitoring through the eChemoCoach reduces the occurrence of CTCAE ≥ 3 non-haematological side effects in breast cancer patients undergoing (neo)adjuvant chemo(immune)therapy. Methods: This multicentre, non-blinded randomised controlled trial will include patients with invasive breast cancer (stage I-III) starting (neo)adjuvant chemo(immune)therapy. A total of 746 (n = 373 intervention, n = 373 controls) patients will be recruited across 12 Dutch hospitals. In addition to standard care, patients in the intervention arm use the eChemoCoach ePRO-questionnaire via the hospitals’ patient portal of the electronic health record (EHR), enabling daily self-reporting of therapy-related symptoms. The ePRO assesses symptom severity using a patient-adapted version of the Common Terminology Criteria for Adverse Events (CTCAE), supplemented with triage questions. Based on severity, the system provides real-time, tailored self-management advice. Patients in the control arm solely receive standard care. The primary outcome is the incidence of non-haematological CTCAE grade ≥ 3 side effects. Secondary outcomes are the effect of the eChemoCoach ePRO on toxicity patterns, relative dose intensity (RDI), HRQoL, anxiety, distress, patient empowerment, unplanned care and usability. Discussion: This is the first RCT to assess an ePRO system fully integrated as a native module within a hospital’s EHR, providing direct access for patients and caregivers, incorporating triage questions to guide symptom assessment, and delivering real-time tailored self-management advice for mild toxicities. This approach may decrease patient burden during chemo(immune)therapy, reduce the occurrence of CTCAE grade ≥ 3 side effects, improve RDI, and reduce clinical workload. Trial registration: Prospectively registered at ClinicalTrials.gov, ID NCT06424054, May 2024.