Validation of an Electronic Remote Toxicity Management System in Cancer Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

134 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-05-18

Study Completion Date

2022-01-12

Brief Summary

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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.

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Detailed Description

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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

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Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Adult cancer patients

Patients will be provided with the QuestOnco application for monitoring

Group Type EXPERIMENTAL

uses of an application

Intervention Type OTHER

Patients will be advised that they can still use their QuestOnco handset if they are hospitalized only for a treatment-related toxicity.

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No