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

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. 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. 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. Prospectively registered at ClinicalTrials.gov, ID NCT06424054, May 2024.