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Clinical Trial Summary

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.

Clinical Trial Description

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. ;

Study Design

Related Conditions & MeSH terms

NCT number NCT04915274
Study type Interventional
Source Centre Hospitalier Régional Metz-Thionville
Contact Arpiné EL NAR
Phone 03 87 55 77 66
Email [email protected]
Status Recruiting
Phase N/A
Start date May 20, 2021
Completion date October 20, 2021

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