Validation of an Electronic Remote Toxicity Management System in Cancer Patients (eRToMSy)

Centre Hospitalier Régional Metz-Thionville

Status

Completed

Conditions

Cancer

Treatments

Other: uses of an application

Study type

Interventional

Funder types

Other

Identifiers

NCT04915274

2020-01-CHRMT

Details and patient eligibility

About

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.

Full 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.

Enrollment

134 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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.

Exclusion criteria