Clinical trial · Interventional
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
Feasibility Assessment of an E-Health System (ZEMY) Designed to Manage Symptoms in Patients With Breast Cancer Under Anti-Cancer Treatment
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Investigator's choice of anti-cancer treatment (except immunotherapy) | Drug | — | UNRESOLVED |
| ZEMY software | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- ZEMY software
- interventionNames
- Device: ZEMY software
- Drug: Investigator's choice of anti-cancer treatment (except immunotherapy)
Primary outcomes (1)
- measure
- Percentage of Participants Who Successfully Use ZEMY
- timeFrame
- 3 months
- 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%.
Secondary outcomes (15)
- 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)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available