Chemotherapy induces side effects varying in severity, impacting patients' quality of life and necessitating unplanned hospital care. Patient-reported outcomes (PROs) could aid in early detection and management of side effects. However, existing PRO monitoring lacks triage capabilities, leading to clinician involvement and suboptimal symptom management. The investigators propose eChemoCoach, an electronic questionnaire integrated into the electronic health portal, offering real-time symptom assessment and personalized advice based on CTCAE criteria. Our study aims to assess the impact of eChemoCoach on non-hematological CTCAE ≥ 3 graded side effects in early breast cancer patients undergoing chemotherapy. This is a randomized controlled trial involving 746 patients that will evaluate the eChemoCoach's efficacy compared to standard monitoring. Phase one will validate questionnaires and assess usability, while phase two focuses on the primary outcome. Te investigators anticipate reduced severe side effects, thereby enhancing patients' quality of life, reducing stress, and minimizing hospital visits.
Four cycles of doxorubicin 60mg/m2 and cyclophosphamide 600mg/m2 (AC) dose dense q 2 weeks, followed by twelve cycles of weekly paclitaxel 80mg/m2 (also in combination with carboplatin AUC6 q 3 weeks)
Nine cycles q 3 weeks of paclitaxel 80mg/m2 on day 1 and 8, carboplatin AUC 3 on day 1 and 8, trastuzumab 8mg/kg loading dose (followed by doses of 6mg/m2 at subsequent cycles) on day1 and pertuzumab loading dose of 840mg (followed by doses of 420mg at subsequent cycles) on day 1
Age ≥ 18 years
WHO PS ≤1
- Participation in a trial with an investigational product (because more frequent and structured symptom reporting is performed in these studies).
Patients who have been treated with chemotherapy in the past (since these patients are at higher risk for developing side effects of current chemotherapy).
Patients that already started with their chemotherapy cycle
Parallel
eChemoCoach
Other interventionthe eChemoCoach is an electronic questionnaire which is accessible for patients via the secured electronic health portal (EHP) of the EHR, which is CE-certified. By utilizing the eChemoCoach, patients (for this project we focus on breast cancer patients) have the ability to complete a questionnaire on a daily basis, when experiencing side effects. The eChemoCoach has the potential to evaluate the severity of adverse effects based on the CTCAE criteria and triage them, mimicking the decision-making process of a HCP through computer adaptive testing (CAT). Upon completing the questionnaire, the eChemoCoach translates the responses for each specific side effect into corresponding CTCAE grades. The tool then promptly offers patients personalized advice, tailored to their individual condition.
The occurrence of any non-hematological side effects grade ≥3
The occurrence of any non-hematological side effects grade ≥3 during neo-adjuvant or adjuvant treatment
Toxicity patterns
Time to occurrence of both grade 2 and grade ≥3 toxicity will be analyzed with a Kaplan-Meier curves. Occurrence of grade 2 side effects during (neo)adjuvant will be presented as numbers with percentages for patients in both study groups.
Relative dose intensity (RDI)
For analyzing the RDI, the RDI will be calculated for each chemotherapeutic agent and presented as mean with standard deviations (SD) (for a description of calculation of the RDI see the objective section paragraph 2.0). The RDI will be calculated per cycle. The RDI will be compared between the intervention and the control group.
HRQOL
Health-related quality of life measured by the Quality of Life Questionnaire (QLQ-C30s). Scale is ranging from 1 to 4. 1 = not at all, 4 = very much. Higher scores mean a worse QOL.
Patient experienced anxiety
Patient experienced anxiety measured using the Hospital Anxiety and Depression Scale. Scale is ranging from 0 to 3. 0 = often, 3 = never. Higher scores means a less worse Hads score.
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Noordwest Ziekenhuisgroep
Lead sponsor
Comprehensive Cancer Centre The Netherlands
Collaborator
University of Twente
Collaborator
Dutch Cancer Society
Collaborator
Borstkanker Onderzoek Groep
Collaborator
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