Clinical trial NCT04915274: Validation of an Electronic Remote Toxicity Management System in Cancer Patients
Official title: Validation of an Electronic Remote Toxicity Management System in Adult Cancer Patients Receiving an Active Anti-cancer Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer
Keywords: Cancer
Active anticancer drug
Quality of life
QuestOnco application
Lead sponsor: Centre Hospitalier Régional Metz-Thionville
Sponsor class: OTHER
First posted: 2021-06-07
Enrollment: 134
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief 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.

Eligibility criteria: 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:

* 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.

Primary outcomes:
measure: Convergent validity
timeFrame: At the end of study completion (Week 6)
Secondary outcomes:
measure: Patients' comprehension of QuestOnco application items
timeFrame: At the end of the study completion: Phase I (Day 7)
measure: The known-groups validity assessment
timeFrame: At the end of the study completion (Week 6)
measure: Evaluation of the efficacy of the QuestOnco application in patient care
timeFrame: At the end of study completion (Week 6)
measure: Evaluation of the responsiveness of the QuestOnco application in patient care
timeFrame: At the end of the study completion (Week 6)
measure: The reliability of the QuestOnco application in patient care
timeFrame: At the end of the study completion (Week 6)
measure: Synchronization of departments (Emergency division, Oncology team) and patients' care
timeFrame: At the end of the study completion (Week 6)
measure: Evaluation of the Quality of Life of patients who use QuestOnco healthcare mobile application
timeFrame: At the end of the study completion (Week 1 and 6)
Other outcomes:
Locations:
city: Metz
country: France
facility: Centre Régional Metz-Thionville
Study officials:
affiliation: CHR METZ THIONVILLE
name: Raffaele LONGO
role: PRINCIPAL_INVESTIGATOR
affiliation: CHR METZ THIONVILLE
name: Véronique NOIREZ
role: STUDY_DIRECTOR
References: