Back to resultsA Study to Assess the Feasibility of an E-Health System (ZEMY) Designed to Manage Symptoms in Participants With Breast Cancer Under Anti-Cancer Treatment (ZEMY)
Primary Purpose
Breast Cancer
Status
Completed
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
ZEMY software
Investigator's choice of anti-cancer treatment (except immunotherapy)
Sponsored by
About this trial
This is an interventional supportive care trial for Breast Cancer
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.
Sites / Locations
- Centre Francois Baclesse; Oncologie
- Centre Jean Perrin; Oncologie
- Hopital Prive Jean Mermoz; Cancerologie
- Hopital Saint Louis; Oncologie Medicale
- Institut du Cancer Coulancy Reims
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
ZEMY software
Arm Description
Outcomes
Primary Outcome Measures
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%.
Secondary Outcome Measures
Percentage of Appropriate Automatic Messages and Recommendations for Each Symptom by ZEMY, as Evaluated by the Investigator at Each Visit
System Usability Scale Score, Rated by Participants and Healthcare Professionals (HCPs)
Satisfaction with ZEMY, Assessed on a Visual Analog Scale by Participants and HCPs
Percentage of Participant Answered Entries per ZEMY Requests for Solicited Symptom Information
Number of Automatic Messages Generated by ZEMY per Participant Over the Study Period
Number of Automatic Messages Generated by ZEMY per Symptom Over the Study Period
Number of Recommendations Generated by ZEMY per Participant Over the Study Period
Number of Recommendations Generated by ZEMY per Symptom Over the Study Period
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.
Number and Type of Adverse Device Effects
Adverse event related to the use of an investigational medical device.
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.
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.
Change From Baseline in the EuroQoL 5-Dimension (EQ-5D-5L) Health Questionnaire Score at Each Study Visit
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
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03558490
Brief Title
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
Acronym
ZEMY
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
2. Study Status
Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
June 12, 2018 (Actual)
Primary Completion Date
April 19, 2019 (Actual)
Study Completion Date
April 19, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hoffmann-La Roche
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
56 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ZEMY software
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
ZEMY software
Intervention Description
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
Drug
Intervention Name(s)
Investigator's choice of anti-cancer treatment (except immunotherapy)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Percentage of Participants Who Successfully Use ZEMY
Description
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%.
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Percentage of Appropriate Automatic Messages and Recommendations for Each Symptom by ZEMY, as Evaluated by the Investigator at Each Visit
Time Frame
At Weeks 3, 6, 9, and 12 (Up to 3 months)
Title
System Usability Scale Score, Rated by Participants and Healthcare Professionals (HCPs)
Time Frame
At 3 months
Title
Satisfaction with ZEMY, Assessed on a Visual Analog Scale by Participants and HCPs
Time Frame
At 3 months
Title
Percentage of Participant Answered Entries per ZEMY Requests for Solicited Symptom Information
Time Frame
3 months
Title
Number of Automatic Messages Generated by ZEMY per Participant Over the Study Period
Time Frame
3 months
Title
Number of Automatic Messages Generated by ZEMY per Symptom Over the Study Period
Time Frame
3 months
Title
Number of Recommendations Generated by ZEMY per Participant Over the Study Period
Time Frame
3 months
Title
Number of Recommendations Generated by ZEMY per Symptom Over the Study Period
Time Frame
3 months
Title
Number and Type of Device Deficiencies
Description
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.
Time Frame
3 months
Title
Number and Type of Adverse Device Effects
Description
Adverse event related to the use of an investigational medical device.
Time Frame
3 months
Title
Number and Type of Serious Adverse Device Effects
Description
Adverse device effect that has resulted in any of the consequences characteristic of a serious adverse event.
Time Frame
3 months
Title
Number and Type of Unanticipated Serious Adverse Device Effects
Description
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.
Time Frame
3 months
Title
Change From Baseline in the EuroQoL 5-Dimension (EQ-5D-5L) Health Questionnaire Score at Each Study Visit
Time Frame
At Baseline and Weeks 3, 6, 9, and 12 (Up to 3 months)
Title
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
Time Frame
At Baseline and Weeks 3, 6, 9, and 12 (Up to 3 months)
Title
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
Time Frame
At Baseline and Weeks 3, 6, 9, and 12 (Up to 3 months)
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trials
Organizational Affiliation
Hoffmann-La Roche
Official's Role
Study Director
Facility Information:
Facility Name
Centre Francois Baclesse; Oncologie
City
Caen
ZIP/Postal Code
14076
Country
France
Facility Name
Centre Jean Perrin; Oncologie
City
Clermont Ferrand
ZIP/Postal Code
63011
Country
France
Facility Name
Hopital Prive Jean Mermoz; Cancerologie
City
Lyon
ZIP/Postal Code
69373
Country
France
Facility Name
Hopital Saint Louis; Oncologie Medicale
City
Paris
ZIP/Postal Code
75475
Country
France
Facility Name
Institut du Cancer Coulancy Reims
City
Reims
ZIP/Postal Code
51100
Country
France
12. IPD Sharing Statement
Learn more about this trial
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
We'll reach out to this number within 24 hrs