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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

NCT03558490

CompletedPhase 2

Sponsor: Hoffmann-La Roche

Conditions: Breast Cancer

Interventions: ZEMY software, Investigator's choice of anti-cancer treatment (except immunotherapy)

Countries: France

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.

Eligibility overview

Sex: FEMALE

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

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.

Locations (5)

Caen, France
Clermont-Ferrand, France
Lyon, France
Paris, France
Reims, France