Mitigating Toxicity by Electronic Health Portal-mediated Interactive Monitoring of Patient-reported Side Effects

Launched by NOORDWEST ZIEKENHUISGROEP · May 16, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new tool called eChemoCoach, which aims to help patients with breast cancer manage the side effects of chemotherapy more effectively. Chemotherapy can cause various side effects that can be quite severe, affecting patients' quality of life and sometimes requiring unplanned visits to the hospital. The eChemoCoach is an electronic questionnaire that patients can use through an online health portal to report their symptoms in real-time. This tool provides personalized advice based on the severity of their side effects, helping doctors respond more quickly and improve overall patient care.

To join this study, participants need to be starting chemotherapy for breast cancer and be at least 18 years old. They should also be able to use the electronic health portal, which may require help if they have difficulty with technology. The trial will involve about 746 patients and will compare the new eChemoCoach system to standard symptom monitoring methods. Participants can expect to provide feedback on their symptoms regularly and receive advice tailored to their needs, with the hope that this will lead to fewer severe side effects, less stress, and fewer trips to the hospital.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• * - Starting (neo)adjuvant treatment with chemotherapy for breast cancer according to one of the below mentioned treatment protocols:
• • 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
• • Capable of using the EHP or get help in case of low (e-)health literacy. This includes being capable of login using DigiD, a system used by the Dutch government to verify the identity of a person
• • Being able to read or get help from a relative in case of illiteracy
• Exclusion Criteria:
• • - 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