Impact on Quality of Life and Health of the CONTINUUM+ CONNECT Remote Monitoring Solution: Prospective, Randomized, Multicenter Trial FEGALA
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 411
- 试验地点
- 13
- 主要终点
- Effect of the CONTINUUM+ CONNECT solution on the results in terms of physical health on the EORTC QLQ-C30 questionnaire in patients with metastatic cancer followed in outpatient settings who did not require assistance in self-assessment
研究概览
简要总结
FEGALA is a comparative, multicenter, randomized, prospective, open-label study comparing the results observed at 3 months (± 15 days) on the EORTC QLQ-C30 scale in a group of patients with metastatic cancer followed on an outpatient basis and benefiting from the CONTINUUM+ CONNECT solution (with or without nursing support at home) versus comparable patients benefiting from conventional monitoring.
详细描述
CONTINUUM+ CONNECT is a platform, accessible from a computer, a smartphone or a tablet, allowing remote monitoring of cancer patients followed on an outpatient basis. The remotely monitored patient is invited to answer questionnaires (regarding adverse events, physiological constants and pain) at home. These questionnaires are either completed by the patient himself, if his condition allows it (self-assessment) or completed with the help of a professional on an outpatient basis (hetero-assessment). The data and alerts are transmitted in real time to the healthcare professionals in charge of the patient who analyze them and then determine the course of action to take.
In order to evaluate the impact of remote monitoring by CONTINUUM+ CONNECT on the quality of life and health of patients with metastatic cancer, the present prospective randomized multicenter study will be carried out.
Four main types of cancer will be studied: Breast, Lung, Colorectal and Prostate cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients aged ≥ 18 years with a solid tumor (only breast, lung, colorectal, prostate cancer) at the metastatic stage followed on an outpatient basis;
- •Patients initiating oral and/or injectable anticancer treatment, whatever the line of treatment, administered on an outpatient basis including day hospitalization;
- •Patients who have given their written, free and informed consent;
- •Patients with life expectancy of more than 3 months;
- •Patients able to complete questionnaires according to the investigator's judgment, and to use the CONTINUUM+ CONNECT electronic application either alone or accompanied by a professional (home nurse);
- •Patients affiliated to a social security scheme or beneficiaries of such a scheme.
排除标准
- •Patients receiving home hospitalization care or being hospitalized at the time of treatment initiation;
- •Patients receiving concomitant radiotherapy;
- •Patients using another remote monitoring application;
- •Patients enrolled in another clinical trial;
- •Patients protected by law.
研究组 & 干预措施
Patients using CONTINUUM+ CONNECT remote monitoring solution
干预措施: CONTINUUM+ CONNECT remote monitoring (Device)
Patients with conventional follow-up without remote monitoring application.
结局指标
主要结局
Effect of the CONTINUUM+ CONNECT solution on the results in terms of physical health on the EORTC QLQ-C30 questionnaire in patients with metastatic cancer followed in outpatient settings who did not require assistance in self-assessment
时间窗: At 3 months (± 15 days) post-inclusion
Difference in physical health score from EORTC QLQ-C30 questionnaire at 3 months (± 15 days) in patients with metastatic cancer depending on intervention group
次要结局
- Effect of CONTINUUM+ CONNECT solution on all dimensions of EORTC QLQ-C30 questionnaires (at 3 months)(At 3 months (± 15 days) post-inclusion)
- Frequency of grade 3 - 4 adverse events present at 3 months post-inclusion(At 3 months (± 15 days) post-inclusion)
- Frequency of grade 3 - 4 adverse events present at 6 months post-inclusion(At 6 months (± 15 days) post-inclusion)
- Satisfaction of patients regarding CONTINUUM+ CONNECT solution and its functioning(At 3 months (± 15 days) post-inclusion)
- Effect of the solution on specific symptom scales depending on the tumor localization (at 3 months) - breast cancer group(At 3 months (± 15 days) post-inclusion)
- Effect of the solution on specific symptom scales depending on the tumor localization (at 3 months) - prostate cancer group(At 3 months (± 15 days) post-inclusion)
- Effect of the solution on specific symptom scales depending on the tumor localization (at 3 months) - colorectal cancer group(At 3 months (± 15 days) post-inclusion)
- Effect of the solution on specific symptom scales depending on the tumor localization (at 6 months) - colorectal cancer group(At 6 months (± 15 days) post-inclusion)
- Effect of the solution on specific symptom scales depending on the tumor localization (at 6 months) - breast cancer group(At 6 months (± 15 days) post-inclusion)
- Effect of the solution on specific symptom scales depending on the tumor localization (at 6 months) - lung cancer group(At 6 months (± 15 days) post-inclusion)
- Percentage of patients with unscheduled hospitalization due to their cancer occurring during the 6 months following inclusion(At 6 months (± 15 days) post-inclusion)
- Effect of CONTINUUM+ CONNECT solution on the results at 3 months (± 15 days) post-inclusion in terms of physical health on the EORTC QLQ-C30 questionnaire in patients with metastatic cancer followed in outpatient settings(At 3 months (± 15 days) post-inclusion)
- Effect of CONTINUUM+ CONNECT solution on all dimensions of EORTC QLQ-C30 questionnaires (at 6 months)(At 6 months (± 15 days) post-inclusion)
- Effect of the solution on specific symptom scales depending on the tumor localization (at 6 months) - prostate cancer group(At 6 months (± 15 days) post-inclusion)
- Percentage of patients with unscheduled hospitalization due to their cancer occurring during the 3 months following inclusion(At 3 months (± 15 days) post-inclusion)
- Effect of the solution on specific symptom scales depending on the tumor localization (at 3 months) - lung cancer group(At 3 months (± 15 days) post-inclusion)
- Satisfaction of professionals regarding CONTINUUM+ CONNECT solution and its functioning(Through out the study, up to 10 months. At least once per professional)