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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

56 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-06-12

Study Completion Date

2019-04-19

Brief Summary

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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.

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Detailed Description

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Conditions

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Breast Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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ZEMY software

Group Type EXPERIMENTAL

ZEMY software

Intervention Type DEVICE

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.

Investigator's choice of anti-cancer treatment (except immunotherapy)

Intervention Type DRUG

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.

Interventions

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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.

Intervention Type DEVICE

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.

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No