Trial reportBMC cancer2024
Content validation of an electronic remote toxicity management system in adult patients undergoing cancer treatment: a prospective longitudinal study on the QuestOnco application.
Trial report in BMC cancer, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04915274 (Validation of an Electronic Remote Toxicity Management System in Adult Cancer Patients Receiving an Active Anti-cancer Treatment), which is not on this map. Not yet cited in PubMed.
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The trial behind it
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Validation of an Electronic Remote Toxicity Management System in Adult Cancer Patients Receiving an Active Anti-cancer Treatment
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10 authors.
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Abstract
backgroundCancer-treatment toxicity is common and symptoms must be identified quickly and accurately. Since symptom reporting during consultations is hampered by time constraints and patient/oncologist biases, patient-reported outcome-measure (PROM) questionnaires are useful. A strong shift to at-home cancer treatment has led to growing interest in remote symptom monitoring via electronic-PROMs (ePROMs). However, because PROMs are generally designed for medical-staff use, ePROMs must be adapted to patient comprehension/abilities. Here, to meet the oncological-healthcare needs of our region, we developed QuestOnco, a mobile-phone ePROM application. It is based on the symptom descriptions and severity grades of the PRO-CTCAE PROM and is designed for real-time on-demand reporting of 34 common or life-threatening cancer-treatment symptoms. This study describes the development of QuestOnco and its content validation relative to two comparators: PRO-CTCAE and the medical records.
methodsThe cohort study was conducted in a tertiary-care hospital in 2021 and consisted of two stages. Stage I assessed the comprehensibility of QuestOnco for patients: 24 cancer-therapy patients were asked to try the application for 30 min and then underwent semi-structured cognitive interviews. Stage II tested QuestOnco-content validity against the comparators: patients starting a ~ 6-week cancer-therapy cycle were asked to use QuestOnco in an on-demand fashion and to complete weekly paper PRO-CTCAEs. Total QuestOnco, PRO-CTCAE, and medical-record symptom reports were compared in terms of symptom and symptom-severity frequencies. Severity concordance of each reported symptom was assessed by Kendall's tau-b rank-correlation coefficients.
resultsIn the second round of 12 Stage-I patients (total Stage-I enrollment rate = 100%), 0% reported comprehension difficulties. 110 patients were recruited for Stage II (enrollment rate = 23%). QuestOnco, PRO-CTCAE, and the medical records detected 85%, 100%, and 62% of the target symptoms at least once, respectively, and reported grade-1, -2, -3, and -4 toxicities with similar frequencies (56-67%, 23-32%, 6-10%, and 2-3%, respectively). Overall symptom-severity concordance was moderate with PRO-CTCAE (tau-b = + 0.21, range = -0.03 to + 0.38) and strong with the medical records (tau-b = + 0.33, range = -0.01 to + 0.61). Few remarkable discrepancies were observed.
conclusionsThe QuestOnco application was well-understood by patients and demonstrated good content validity compared to its parent PROM and the medical records.
trial registrationClinicalTrials.gov No. NCT04915274.
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