Clinical trial · Interventional
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
NCT04915274CI-TRIAL-00115728eRToMSycompletedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| uses of an application | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Adult cancer patients
- description
- Patients will be provided with the QuestOnco application for monitoring
- interventionNames
- Other: uses of an application
Primary outcomes (1)
- measure
- Convergent validity
- timeFrame
- At the end of study completion (Week 6)
- description
- PRO-CTCAE The convergent validity will be evaluated by the correlation between the QuestOnco and the weekly paper form of the PRO-CTCAE questionnaire. PRO-CTCAE is a patient-reported outcome (PRO) measurement system developed to evaluate symptomatic toxicity in patients on cancer clinical trials. It was designed to be used as a companion to the Common Terminology Criteria for Adverse Events (CTCAE) External Web Site Policy, the standard lexicon for adverse event reporting in cancer clinical trials. The PRO-CTCAE Item Library includes 124 items representing 78 symptomatic toxicities drawn from the CTCAE. PRO-CTCAE items evaluate the symptom attributes of frequency, severity, interference, amount, presence/absence. Each symptomatic AE is assessed by 1-3 attributes. PRO-CTCAE responses are scored from 0 to 4 (minimum/maximum).
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (1)
- RESULTLongo R, Goetz C, Campitiello M, Plastino F, Egea J, Legros PO, Elnar AA, Meraihi S, Luporsi E, Noirez V. Content validation of an electronic remote toxicity management system in adult patients undergoing cancer treatment: a prospective longitudinal study on the QuestOnco application. BMC Cancer. 2024 Dec 23;24(1):1568. doi: 10.1186/s12885-024-13312-4. PMID 39716103