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

Breast Cancer Clinical Trial

— ZEMY  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03558490
• Other study ID #: ML39208
• Status: Completed
• Phase: Phase 2
• Start date: June 12, 2018
• Est. completion date: April 19, 2019

Study information

• Verified date: July 2019
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: April 19, 2019
• Est. primary completion date: April 19, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

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.

Locations

Country	Name	City	State
France	Centre Francois Baclesse; Oncologie	Caen
France	Centre Jean Perrin; Oncologie	Clermont Ferrand
France	Hopital Prive Jean Mermoz; Cancerologie	Lyon
France	Hopital Saint Louis; Oncologie Medicale	Paris
France	Institut du Cancer Coulancy Reims	Reims

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants Who Successfully Use ZEMY	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%.	3 months
Secondary	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)
Secondary	System Usability Scale Score, Rated by Participants and Healthcare Professionals (HCPs)		At 3 months
Secondary	Satisfaction with ZEMY, Assessed on a Visual Analog Scale by Participants and HCPs		At 3 months
Secondary	Percentage of Participant Answered Entries per ZEMY Requests for Solicited Symptom Information		3 months
Secondary	Number of Automatic Messages Generated by ZEMY per Participant Over the Study Period		3 months
Secondary	Number of Automatic Messages Generated by ZEMY per Symptom Over the Study Period		3 months
Secondary	Number of Recommendations Generated by ZEMY per Participant Over the Study Period		3 months
Secondary	Number of Recommendations Generated by ZEMY per Symptom Over the Study Period		3 months
Secondary	Number and Type of Device Deficiencies	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.	3 months
Secondary	Number and Type of Adverse Device Effects	Adverse event related to the use of an investigational medical device.	3 months
Secondary	Number and Type of Serious Adverse Device Effects	Adverse device effect that has resulted in any of the consequences characteristic of a serious adverse event.	3 months
Secondary	Number and Type of Unanticipated Serious Adverse Device Effects	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.	3 months
Secondary	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)
Secondary	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)
Secondary	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)