Trials
Search / Trial NCT06424054

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

Launched by NOORDWEST ZIEKENHUISGROEP · May 16, 2024

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Trial Information

Current as of March 14, 2025

Not yet recruiting

Keywords

Breast Cancer Remote Monitoring Emonitoring E Health Symptom Management Symptom Monitoring

ClinConnect Summary

Problem description: The aim of (neo)adjuvant chemotherapy is to increase survival. Therefore, treatment adherence is important. However, patients may experience treatment-related side-effects. In current practice, clinicians evaluate toxicity just a few days before the next chemotherapy is scheduled. Monitoring and timely anticipation of chemotherapy related side-effects may prevent escalation of toxicity, increase treatment adherence and reduce the decline in quality of life. Evaluating toxicity more frequently and on-demand could be a solution to reduce severe toxicity. Therefore, patien...

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

About Noordwest Ziekenhuisgroep

Noordwest Ziekenhuisgroep is a leading healthcare institution in the Netherlands, dedicated to providing high-quality patient care and advancing medical research through innovative clinical trials. With a commitment to improving health outcomes, the organization fosters collaboration among multidisciplinary teams to explore new treatment options and enhance existing therapies. Noordwest Ziekenhuisgroep emphasizes ethical standards and patient safety in all its research endeavors, ensuring that clinical trials are conducted with the utmost rigor and adherence to regulatory guidelines. Through its research initiatives, the institution aims to contribute significantly to the medical community and improve the lives of patients both locally and globally.

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Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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