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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ZEMY software | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ZEMY software | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | |
| System Usability Scale Score, Rated by Participants and Healthcare Professionals (HCPs) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Francois Baclesse; Oncologie | Caen | 14076 | France | |||
| Centre Jean Perrin; Oncologie |
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| Investigator's choice of anti-cancer treatment (except immunotherapy) | 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. |
|
| At 3 months |
| Satisfaction with ZEMY, Assessed on a Visual Analog Scale by Participants and HCPs | At 3 months |
| Percentage of Participant Answered Entries per ZEMY Requests for Solicited Symptom Information | 3 months |
| Number of Automatic Messages Generated by ZEMY per Participant Over the Study Period | 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 of Recommendations Generated by ZEMY per Symptom Over the Study Period | 3 months |
| 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 |
| Number and Type of Adverse Device Effects | Adverse event related to the use of an investigational medical device. | 3 months |
| 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 |
| 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 |
| 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) |
| 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) |
| 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) |
| Clermont-Ferrand |
| 63011 |
| France |
| Hopital Prive Jean Mermoz; Cancerologie | Lyon | 69373 | France |
| Hopital Saint Louis; Oncologie Medicale | Paris | 75475 | France |
| Institut du Cancer Coulancy Reims | Reims | 51100 | France |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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