Evidence map›Paper›PMID 39716103›Full record

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.

Raffaele Longo, Christophe Goetz, Marco Campitiello, Francesca Plastino, Julie Egea, Pierre-Olivier Legros, Arpiné Ardzivian Elnar, Salma Meraihi, Elisabeth Luporsi, Véronique Noirez

Registry-linked trialAbstract readValidation StudyClinical Trial
In one paragraph

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.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT04915274 nacompletednot on this map

Validation of an Electronic Remote Toxicity Management System in Adult Cancer Patients Receiving an Active Anti-cancer Treatment

TypeinterventionalSponsorCentre Hospitalier Régional Metz-ThionvilleRan2021 to 2022Enrolled134ConditionsCancerArmsuses of an application
3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

10 authors.

Raffaele LongoDivision of Medical Oncology, Central Regional Hospital Metz-Thionville, 1 Allée du Château, Ars-Laquenexy, 57085, France. raffaele.longo@chr-metz-thionville.fr.
Christophe GoetzClinical Research Support Unit, Central Regional Hospital Metz-Thionville, 1 Allée du Château, Ars-Laquenexy, 57085, France.
Marco CampitielloDivision of Medical Oncology, Central Regional Hospital Metz-Thionville, 1 Allée du Château, Ars-Laquenexy, 57085, France.
Francesca PlastinoDivision of Medical Oncology, Central Regional Hospital Metz-Thionville, 1 Allée du Château, Ars-Laquenexy, 57085, France.
Julie EgeaDivision of Medical Oncology, Central Regional Hospital Metz-Thionville, 1 Allée du Château, Ars-Laquenexy, 57085, France.
Pierre-Olivier LegrosDivision of Medical Oncology, Central Regional Hospital Metz-Thionville, 1 Allée du Château, Ars-Laquenexy, 57085, France.
Arpiné Ardzivian ElnarClinical Research Support Unit, Central Regional Hospital Metz-Thionville, 1 Allée du Château, Ars-Laquenexy, 57085, France.
Salma MeraihiClinical Research Support Unit, Central Regional Hospital Metz-Thionville, 1 Allée du Château, Ars-Laquenexy, 57085, France.
Elisabeth LuporsiDivision of Medical Oncology, Central Regional Hospital Metz-Thionville, 1 Allée du Château, Ars-Laquenexy, 57085, France.
Véronique NoirezDepartment of Pharmacology, Central Regional Hospital Metz-Thionville, 1 Allée du Château, Ars-Laquenexy, 57085, France.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

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.

Indexed as

NeoplasmsAdultAgedDrug-Related Side Effects and Adverse ReactionsFemaleHumansLongitudinal StudiesMaleMiddle AgedMobile ApplicationsPatient Reported Outcome MeasuresProspective StudiesSurveys and QuestionnairesTelemedicineCancerChemotherapyElectronic devicePatient-reported outcomesToxicity

Identifiers

PMID39716103
PMCPMC11665079

What Socratic holds

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LicenceCC BY-NC-ND
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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.