NCT03558490

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 56 (actual)
• Sponsor: Hoffmann-La Roche · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
DEVICE	ZEMY software	The ZEMY software medical device integrates specific algorithms based on international and validated guidelines. It provides individually customized information and defines for the patient an adapted action to follow for each of the following reported symptoms or anti-cancer treatment-related toxicities: diarrhea, fatigue, nausea, vomiting, cutaneous and mucosal toxicities, pain, fever/febrile neutropenia, high blood pressure, anxiety and depression. During the 3-month study period, participants will be asked to enter their symptoms among the 10 symptoms listed in ZEMY on their smartphone dedicated to the study. Consequently, ZEMY software will provide to the participants adapted real-time information to advise them on the management of the experienced symptom and recommend hygienic-dietetic advice and symptomatic treatments.
DRUG	Investigator's choice of anti-cancer treatment (except immunotherapy)	All anti-cancer treatments (except immunotherapy) will be left to the free choice of investigators. Participants shall be prescribed by the healthcare team both of the following symptomatic treatments: loperamide or any other anti-diarrheic treatment in case of diarrhea; and a prescription for any medication indicated in case of nausea/vomiting. A written prescription will be made by the investigator at screening for loperamide or any other anti-diarrheic treatment and symptomatic treatment for nausea/vomiting with documented dosage and duration.

Timeline

• Start date: 2018-06-12
• Primary completion: 2019-04-19
• Completion: 2019-04-19
• First posted: 2018-06-15
• Last updated: 2019-07-22

Locations

5 sites across 1 country: France