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

• Status: Completed
• Trial end date: 2019-04-19
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hoffmann-La Roche

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.