NCT04915274

Validation of an Electronic Remote Toxicity Management System in Cancer Patients

Validation of an Electronic Remote Toxicity Management System in Adult Cancer Patients Receiving an Active Anti-cancer Treatment

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 134 (actual)
• Sponsor: Centre Hospitalier Régional Metz-Thionville · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Cancer

Interventions

Type	Name	Description
OTHER	uses of an application	Patients will be advised that they can still use their QuestOnco handset if they are hospitalized only for a treatment-related toxicity.

Timeline

• Start date: 2021-05-18
• Primary completion: 2022-01-12
• Completion: 2022-01-12
• First posted: 2021-06-07
• Last updated: 2022-01-18

Locations

1 site across 1 country: France