NCT03558490已完成2 期
Feasibility Assessment of an E-Health System (ZEMY) Designed to Manage Symptoms in Patients With Breast Cancer Under Anti-Cancer Treatment
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 56
- 试验地点
- 5
- 主要终点
- Percentage of Participants Who Successfully Use ZEMY
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
ZEMY software
Experimental
干预措施: ZEMY software (Device)
ZEMY software
Experimental
干预措施: Investigator's choice of anti-cancer treatment (except immunotherapy) (Drug)
结局指标
主要结局
Percentage of Participants Who Successfully Use ZEMY
时间窗: 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%.
次要结局
- 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))
- Satisfaction with ZEMY, Assessed on a Visual Analog Scale by Participants and HCPs(At 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))
- 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 and Type of Device Deficiencies(3 months)
- Number and Type of Adverse Device Effects(3 months)
- Percentage of Participant Answered Entries per ZEMY Requests for Solicited Symptom Information(3 months)
- System Usability Scale Score, Rated by Participants and Healthcare Professionals (HCPs)(At 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))
- Number of Automatic Messages 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 Unanticipated Serious Adverse Device Effects(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))
- Number and Type of Serious Adverse Device Effects(3 months)
研究者
研究点 (5)
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