Validation of an Electronic Remote Toxicity Management System in Adult Cancer Patients Receiving an Active Anti-cancer Treatment
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 134
- 试验地点
- 2
- 主要终点
- Convergent validity
研究概览
简要总结
To assess the psychometric properties (validity, reliability and responsiveness) of the QuestOnco tool, an electronic Remote Toxicity Management System, in adult cancer patients receiving an active anti-cancer treatment.
详细描述
In this study, a mobile phone-based remote monitoring system (QuestOnco application) was developed in order to enable the 'real-time' monitoring of patients' symptoms through use of ePROMs. In order to establish if this new application accurately and reliably identifies the anti-cancer treatment related symptoms, its psychometric properties (validity, reliability and responsiveness) have to be assessed.
Hypotheses:
- The QuestOnco application will be designed as a promising innovative tool with good psychometric properties in order to detect more rapidly the anti-cancer-related toxicity in adult cancer patients.
- The QuestOnco application is an accurate and reliable tool for the identification of the anti-cancer treatment related symptoms as much as current available questionnaires such as PRO-CTCAE and EORTC QLC-QC30 The evaluation of the psychometric properties of the QuestOnco application will be made in two phases. First, the patient's cognitive interviews will allow assessing the content validity of the items. Then focus groups including patients and professional experts will determine the QuestOnco application goals regarding the adverse symptoms management (recommendations provided within the application, connection with General practitioner, medical Oncology team or Emergency departments).
This study will assess the validity, reliability and responsiveness of the QuestOnco in a cohort of patients receiving anti-cancer treatments. The external validity will be directly compared to PRO-CTCAE (Patient-Reported Outcome Common Terminology Criteria for Adverse Events) and to EORTC QLC-QC30 questionnaire.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 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
- •Adults (≥18 years);
- •Written and informed consent;
- •Diagnosis of solid cancer;
- •Metastatic or (neo)adjuvant anti-cancer treatment, including intravenous and/or oral treatments;
- •Patient physically/psychologically fit to participate in the study;
- •Patient able to understand, communicate and use the electronic device;
- •Patient owning a smartphone or tablet with internet connection;
- •Treatment supported by the French social security system.
排除标准
- •Unable patient for signing informed consent;
- •Unable to understand, communicate and use the electronic device;
- •Patient under trusteeship or guardianship;
- •Patient under legal or administration protection.
研究组 & 干预措施
Adult cancer patients
Patients will be provided with the QuestOnco application for monitoring
干预措施: uses of an application (Other)
结局指标
主要结局
Convergent validity
时间窗: At the end of study completion (Week 6)
PRO-CTCAE The convergent validity will be evaluated by the correlation between the QuestOnco and the weekly paper form of the PRO-CTCAE questionnaire. PRO-CTCAE is a patient-reported outcome (PRO) measurement system developed to evaluate symptomatic toxicity in patients on cancer clinical trials. It was designed to be used as a companion to the Common Terminology Criteria for Adverse Events (CTCAE) External Web Site Policy, the standard lexicon for adverse event reporting in cancer clinical trials. The PRO-CTCAE Item Library includes 124 items representing 78 symptomatic toxicities drawn from the CTCAE. PRO-CTCAE items evaluate the symptom attributes of frequency, severity, interference, amount, presence/absence. Each symptomatic AE is assessed by 1-3 attributes. PRO-CTCAE responses are scored from 0 to 4 (minimum/maximum).
次要结局
- Evaluation of the efficacy of the QuestOnco application in patient care(At the end of study completion (Week 6))
- Synchronization of departments (Emergency division, Oncology team) and patients' care(At the end of the study completion (Week 6))
- Patients' comprehension of QuestOnco application items(At the end of the study completion: Phase I (Day 7))
- The known-groups validity assessment(At the end of the study completion (Week 6))
- Evaluation of the responsiveness of the QuestOnco application in patient care(At the end of the study completion (Week 6))
- The reliability of the QuestOnco application in patient care(At the end of the study completion (Week 6))
- Evaluation of the Quality of Life of patients who use QuestOnco healthcare mobile application(At the end of the study completion (Week 1 and 6))