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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.
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Adult cancer patients | Experimental | Patients will be provided with the QuestOnco application for monitoring |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| uses of an application | Other | Patients will be advised that they can still use their QuestOnco handset if they are hospitalized only for a treatment-related toxicity. |
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| Measure | Description | Time Frame |
|---|---|---|
| Convergent validity | 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). | At the end of study completion (Week 6) |
| Measure | Description | Time Frame |
|---|---|---|
| Patients' comprehension of QuestOnco application items | Semi-structured cognitive interviews: Interviews will be conducted to evaluate patients' comprehension of the QuestOnco application items. Items will be modified and restested if more than 2 patients manifest cognitive difficulties. The item modifications will be conducted during focus groups gathering experts including Emergency department practitioners, General practitioner, Oncologists, Pharmacists, and Methodologists. This procedure will be repeated 3 times a maximum for a total of 30 patients. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Raffaele LONGO | CHR METZ THIONVILLE | Principal Investigator |
| Véronique NOIREZ | CHR METZ THIONVILLE | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Régional Metz-Thionville | Metz | 57085 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39716103 | Result | Longo 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. |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
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| At the end of the study completion: Phase I (Day 7) |
| The known-groups validity assessment | The known-groups validity will be assessed by comparing the QuestOnco items between patients with high and low performance status using the Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1 vs 2-4 (minimum vs maximum). | At the end of the study completion (Week 6) |
| Evaluation of the efficacy of the QuestOnco application in patient care | Calculation of the time spent (minutes) in consultation with the Oncologist using QuestOnco application fill form | At the end of study completion (Week 6) |
| Evaluation of the responsiveness of the QuestOnco application in patient care | Calculation of the number (percent) of appointments actually realized using QuestOnco application fill form | At the end of the study completion (Week 6) |
| The reliability of the QuestOnco application in patient care | Calculation of the number (percent) of the automatic telephone alert calls to the regional Emergency service using QuestOnco application fill form | At the end of the study completion (Week 6) |
| Synchronization of departments (Emergency division, Oncology team) and patients' care | Calculation of the number (percent) of scheduled consultation based on the statement of reported-toxicity score (symptom severity from grades II to IV) of cancer patients using electronic mobile QuestOnco application. | At the end of the study completion (Week 6) |
| Evaluation of the Quality of Life of patients who use QuestOnco healthcare mobile application | The patients' quality of life will be assessed using EORTC QLC-QC30 questionnaire The EORTC QLQ-C30 is a 30-item core-cancer-specific questionnaire-integrating system for assessing the health-related QOL of cancer patients participating in international clinical trials. The questionnaire incorporates five functional scales (physical, role, cognitive, emotional, and social), three symptom scales (fatigue, pain, and nausea and vomiting), a global health and QOL scale, and single items for the assessment of additional symptoms commonly reported by cancer patients (e.g., dyspnea, appetite loss, sleep disturbance, constipation, and diarrhea), as well as the perceived financial impact of the disease and treatment. All items are scored on 4-point Likert scales, ranging from 1 ('not at all') to 4 ('very much'), with the exception of two items in the global health/QOL scale which use modified 7-point linear analog scales. | At the end of the study completion (Week 1 and 6) |