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

Phase 2

Completed

• Conditions: Breast Cancer
• Interventions: Device: ZEMY software; Drug: Investigator's choice of anti-cancer treatment (except immunotherapy)

• Registration Number: NCT03558490
• Lead Sponsor: Hoffmann-La Roche

Brief 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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2018-06-04
• Study Start: 2018-06-12
• Study First Submitted QC: 2018-06-14
• Study First Posted: 2018-06-15
• Primary Completion: 2019-04-19
• Study Completion: 2019-04-19
• Status Verified: 2019-07
• Last Update Submitted: 2019-07-18
• Last Update Posted: 2019-07-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 56

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
ZEMY software	Investigator's choice of anti-cancer treatment (except immunotherapy)	-
ZEMY software	ZEMY software	-

Primary Outcome Measures

Name	Time	Method
Percentage of Participants Who Successfully Use ZEMY	3 months	A participant will be considered as successful in terms of the feasibility of using ZEMY if she has completed at least three symptom reported connections and if the rate of completed symptom reported connections for this participant is ≥ 60%.

Secondary Outcome Measures

Name	Time	Method
Percentage of Appropriate Automatic Messages and Recommendations for Each Symptom by ZEMY, as Evaluated by the Investigator at Each Visit	At Weeks 3, 6, 9, and 12 (Up to 3 months)
Satisfaction with ZEMY, Assessed on a Visual Analog Scale by Participants and HCPs	At 3 months
Change From Baseline in the European Organization for Research and Treatment of Cancer's Quality-of-Life Questionnaire (EORTC QLQ-30) Score at Each Study Visit	At Baseline and Weeks 3, 6, 9, and 12 (Up to 3 months)
Number of Automatic Messages Generated by ZEMY per Symptom Over the Study Period	3 months
Number of Recommendations Generated by ZEMY per Participant Over the Study Period	3 months
Number and Type of Device Deficiencies	3 months	Inadequacy of an investigational medical device related to its identity, quality, durability, reliability, safety or performance. This may include malfunctions, use error, or inadequacy in the information supplied by the manufacturer.
Number and Type of Adverse Device Effects	3 months	Adverse event related to the use of an investigational medical device.
Percentage of Participant Answered Entries per ZEMY Requests for Solicited Symptom Information	3 months
System Usability Scale Score, Rated by Participants and Healthcare Professionals (HCPs)	At 3 months
Change From Baseline in the European Organization for Research and Treatment of Cancer's Breast Cancer-Specific Quality-of-Life Questionnaire (EORTC QLQ-BR23) Score at Each Study Visit	At Baseline and Weeks 3, 6, 9, and 12 (Up to 3 months)
Number of Automatic Messages Generated by ZEMY per Participant Over the Study Period	3 months
Number of Recommendations Generated by ZEMY per Symptom Over the Study Period	3 months
Number and Type of Unanticipated Serious Adverse Device Effects	3 months	Serious adverse device effect which by its nature, incidence, severity or outcome has not been identified in the current version of the risk analysis report.
Change From Baseline in the EuroQoL 5-Dimension (EQ-5D-5L) Health Questionnaire Score at Each Study Visit	At Baseline and Weeks 3, 6, 9, and 12 (Up to 3 months)
Number and Type of Serious Adverse Device Effects	3 months	Adverse device effect that has resulted in any of the consequences characteristic of a serious adverse event.

Trial Locations

Locations (5)

Centre Francois Baclesse; Oncologie; 🇫🇷 Caen, France

Hopital Prive Jean Mermoz; Cancerologie; 🇫🇷 Lyon, France

Centre Jean Perrin; Oncologie; 🇫🇷 Clermont Ferrand, France

Institut du Cancer Coulancy Reims; 🇫🇷 Reims, France

Hopital Saint Louis; Oncologie Medicale; 🇫🇷 Paris, France