Clinical trial 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
Official title: Feasibility Assessment of an E-Health System (ZEMY) Designed to Manage Symptoms in Patients With Breast Cancer Under Anti-Cancer Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Breast Cancer
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2018-06-15
Enrollment: 56
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Percentage of Participants Who Successfully Use ZEMY
timeFrame: 3 months
Secondary outcomes:
measure: Percentage of Appropriate Automatic Messages and Recommendations for Each Symptom by ZEMY, as Evaluated by the Investigator at Each Visit
timeFrame: At Weeks 3, 6, 9, and 12 (Up to 3 months)
measure: System Usability Scale Score, Rated by Participants and Healthcare Professionals (HCPs)
timeFrame: At 3 months
measure: Satisfaction with ZEMY, Assessed on a Visual Analog Scale by Participants and HCPs
timeFrame: At 3 months
measure: Percentage of Participant Answered Entries per ZEMY Requests for Solicited Symptom Information
timeFrame: 3 months
measure: Number of Automatic Messages Generated by ZEMY per Participant Over the Study Period
timeFrame: 3 months
measure: Number of Automatic Messages Generated by ZEMY per Symptom Over the Study Period
timeFrame: 3 months
measure: Number of Recommendations Generated by ZEMY per Participant Over the Study Period
timeFrame: 3 months
measure: Number of Recommendations Generated by ZEMY per Symptom Over the Study Period
timeFrame: 3 months
measure: Number and Type of Device Deficiencies
timeFrame: 3 months
measure: Number and Type of Adverse Device Effects
timeFrame: 3 months
measure: Number and Type of Serious Adverse Device Effects
timeFrame: 3 months
measure: Number and Type of Unanticipated Serious Adverse Device Effects
timeFrame: 3 months
measure: Change From Baseline in the EuroQoL 5-Dimension (EQ-5D-5L) Health Questionnaire Score at Each Study Visit
timeFrame: At Baseline and Weeks 3, 6, 9, and 12 (Up to 3 months)
measure: 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
timeFrame: At Baseline and Weeks 3, 6, 9, and 12 (Up to 3 months)
measure: 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
timeFrame: At Baseline and Weeks 3, 6, 9, and 12 (Up to 3 months)
Other outcomes:
Locations:
city: Caen
country: France
facility: Centre Francois Baclesse; Oncologie
city: Clermont Ferrand
country: France
facility: Centre Jean Perrin; Oncologie
city: Lyon
country: France
facility: Hopital Prive Jean Mermoz; Cancerologie
city: Paris
country: France
facility: Hopital Saint Louis; Oncologie Medicale
city: Reims
country: France
facility: Institut du Cancer Coulancy Reims
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: