Evaluation of Performance and Safety of APP RITA in Increasing the Therapeutic Adherence of Onco-Hematological Patients - a Prospective Monocentric Pre-Market Study with a Historical Group of Comparison
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 124
- 试验地点
- 2
- 主要终点
- Evaluating changes in actual dose intensity
研究概览
简要总结
It is essential to improve clinical efficiency and management of hematological and oncological patients treated on an outpatient basis. The most promising operative way to achieve this result is the development of tele-oncology platforms, that allow not only a telemedicine visit, but also the patient support in the daily management of the disease and related disorders, as well as treatments and their complications. In this perspective, the RITA communication platform should be able to support the patient, the caregiver, the physician and the general practitioner in the management of the disease and its treatments.
详细描述
Summary description of the investigational device:
The RITA "Remote Intelligence for Therapeutic Adherence" application was designed, on the doctor's side, as a support for the management of the onco-hematological patient and, on the patient's side, as a first aid tool for the management of the most common problems, as well as an efficient and "non-invasive" means of communication with the doctor. The system also allows the caregiver and general practitioner to be included in the communication group.
The added value of the app consists in improving the relationship between the patient and the doctor, creating an effective communication channel, increasing the safety the patient has when facing his difficult path, reducing the number of visits to the facility and, in general, making those visits more efficient, thus creating savings both in terms of time and resources. RITA is also designed to communicate and receive information on the quality of life and side effects, thus making the medical doctor aware of the progress of treatments in his patient population.
Often occurs that the mild drug/disease related symptoms that the patient perceive during the treatment period are underestimated, leading to a more severe symptomatology that could impair the patient adherence to treatment. Thanks to the app RITA, on the patients side it will be easier to notify their daily physical condition, while on the physician side it will be easier to manage and solve the mild symptoms the patient could face during the treatment period, improving the overall adherence to the treatment.
The mobile app, which can also be used on a conventional desktop or laptop, aims to optimize the interaction between the onco-hematological patient and the referring physician. The hospital doctor will have access to the website, in order to manage all the functions through the appropriate dashboard.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 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
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who understand and voluntarily sign an informed consent form (ICF) prior to any study related procedures being conducted;
- •Patients who are ≥ 18 years old;
- •Patients who are diagnosed with a onco-hematologic disease, namely: Symptomatic Multiple Myeloma, Solitary Plasmocytoma, Amyloidosis, Chronic Myeloid Leukemia, Chronic Lymphocytic Leukemia, Lymphocytic Lymphoma, Hodgkin Lymphoma, B cells non-Hodgkin Lymphoma, T cells non-Hodgkin Lymphoma, Acute myeloid Leukemia, Myelodysplasia, Chronic Myeloproliferative Disorder;
- •Patients who receive a standard of care therapy for their disease, independently from the route of administration;
- •Patients in their first or subsequent line of therapy;
- •Patients at the beginning of the treatment, or during therapy;
- •Life expectancy > 6 months.
排除标准
- •Patients treated with radiotherapy only;
- •Presence of clinical conditions that will impair the adherence to the treatment (ie, concomitant tumor on treatment, severe neurologic disease, drug or alcohol abuse etc.);
- •Patient unable to use a smartphone and/or a computer (ie blindness, inability to use a smartphone or a computer etc.);
- •Major psychopathology or cognitive impairment likely in the judgment of the research staff to interfere with the participation or completion of the protocol;
- •Patient enrolled in another clinical trial.
结局指标
主要结局
Evaluating changes in actual dose intensity
时间窗: Daily/ Assessment at each month for three months
The primary outcome is defined as the comparison between the proportion of patients with at least 20% of increase in the relative dose intensity (defined as the ratio of delivered dose intensity to the prescribed referenced dose intensity, expressed as a percentage) of anticancer treatment during the study period in the two arms (i.e., intervention and historical group). The actual delivered dose intensity will be evaluated at each follow up visit through the drug accountability performed onsite.
次要结局
- Number of grade 3-4 adverse events(Daily/ Assessment at each month for three months)
- Number of visits to the Emergency Room(Daily/ Assessment at each month for three months)
- Quality of life change - Questionnaire EQ-5D-5L(Daily/ Assessment at each month for three months)
- Number of days in hospital(Daily/ Assessment at each month for three months)
- Quality of life change - Questionnaire EORTC QLQC30(Daily/ Assessment at each month for three months)
- RITA APP Experience evaluation(Daily/ Assessment at each month for three months)