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

PHASE2CompletedINTERVENTIONAL
Enrollment

56

Participants

Timeline

Start Date

June 12, 2018

Primary Completion Date

April 19, 2019

Study Completion Date

April 19, 2019

Conditions
Breast Cancer
Interventions
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.

Trial Locations (5)

14076

Centre Francois Baclesse; Oncologie, Caen

51100

Institut du Cancer Coulancy Reims, Reims

63011

Centre Jean Perrin; Oncologie, Clermont-Ferrand

69373

Hopital Prive Jean Mermoz; Cancerologie, Lyon

75475

Hopital Saint Louis; Oncologie Medicale, Paris

All Listed Sponsors
lead

Hoffmann-La Roche

INDUSTRY

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 | Biotech Hunter | Biotech Hunter