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NCT Number: 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

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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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Centre Francois Baclesse; Oncologie, Caen, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

Primary outcomes

  1. Percentage of Participants Who Successfully Use ZEMY

    Time frame: 3 months

    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

  1. 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)

  2. System Usability Scale Score, Rated by Participants and Healthcare Professionals (HCPs)

    Time frame: At 3 months

  3. Satisfaction with ZEMY, Assessed on a Visual Analog Scale by Participants and HCPs

    Time frame: At 3 months

  4. Percentage of Participant Answered Entries per ZEMY Requests for Solicited Symptom Information

    Time frame: 3 months

  5. Number of Automatic Messages Generated by ZEMY per Participant Over the Study Period

    Time frame: 3 months

  6. Number of Automatic Messages Generated by ZEMY per Symptom Over the Study Period

    Time frame: 3 months

  7. Number of Recommendations Generated by ZEMY per Participant Over the Study Period

    Time frame: 3 months

  8. Number of Recommendations Generated by ZEMY per Symptom Over the Study Period

    Time frame: 3 months

  9. Number and Type of Device Deficiencies

    Time frame: 3 months

    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.

  10. Number and Type of Adverse Device Effects

    Time frame: 3 months

    Adverse event related to the use of an investigational medical device.

  11. Number and Type of Serious Adverse Device Effects

    Time frame: 3 months

    Adverse device effect that has resulted in any of the consequences characteristic of a serious adverse event.

  12. Number and Type of Unanticipated Serious Adverse Device Effects

    Time frame: 3 months

    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.

  13. 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)

  14. 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)

  15. 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)

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study title

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

Acronym: ZEMY

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Jun 15, 2018
Registry last updated
Jul 22, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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