A Study to Assess the Feasibility of an E-Health System (ZEMY) Designed to Manage Symptoms in Participants With Breast Cancer Under Anti-Cancer Treatment

  • Breast Cancer
Trial Status:

Completed

This trial runs in
Cities
  • Caen
  • Clermont-Ferrand
  • Lyon
  • Paris
  • Reims
Trial Identifier:

NCT03558490 ML39208

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      The source of the below information is the publicly available website ClinicalTrials.gov. It has been summarised and edited into simpler language.

      The below information is taken directly from the publicly available website ClinicalTrials.gov within a week of any updates, and has not been edited.

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      Trial Summary

      This is a three-month open-label, multicenter, interventional, single arm study located in France, designed to assess feasibility and reliability of the e-Health ZEMY software medical device under investigation for use by participants with breast cancer, who are starting an anti-cancer treatment at any stage of the disease, to manage disease symptoms and anti-cancer treatment-related toxicities while at home.

      Hoffmann-La Roche Sponsor
      Phase 2 Phase
      NCT03558490 , ML39208 Trial Identifier
      ZEMY software, Investigator's choice of anti-cancer treatment (except immunotherapy) Treatments
      Breast Cancer Condition
      Official Title

      Feasibility Assessment of an E-Health System (ZEMY) Designed to Manage Symptoms in Patients With Breast Cancer Under Anti-Cancer Treatment

      Eligibility Criteria

      Female Gender
      ≥ 18 Years Age
      No Healthy Volunteers
      Inclusion Criteria
      • Female patients with breast cancer starting a treatment including oral and/or parenteral anti-cancer drugs (chemotherapy and/or targeted therapies, hormonotherapy)
      • Inter-cycle duration between hospital visits ≥14 days (this period of time is estimated to be consistent with a need for support during the home setting period)
      • Patients shall be prescribed loperamide or any other anti-diarrheic treatment in case of diarrhea and prescription for any medication indicated in case of nausea/vomiting
      • Able to speak and read French and to use a smartphone embedding ZEMY, in the investigator's judgment
      • Able to comply with the study protocol, in the investigator's judgment
      • Patient affiliated to the national social security or beneficiary to such insurance.
      Exclusion Criteria
      • Pregnant
      • Already enrolled in a clinical study involving experimental medication or eHealth device
      • Concomitant malignancy
      • ECOG score >2
      • Treated with single hormonotherapy, single surgery or single radiotherapy, immunotherapy.
      • Patient whose mental state renders her unable to understand the nature, purposes, and consequences of the study
      • Patient not trained to the use of ZEMY
      • Patient not trained to take her blood pressure measurement
      • Patient deprived of her liberty by judicial or administrative order.

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