Surveillance logicielle des toxicités liées au traitement dans le carcinome rénal avancé
15 avril 2026 mis à jour par: Chunkit Fung, University of Rochester
Surveillance des toxicités liées au traitement par les agents oraux ciblés et l'immunothérapie chez les patients atteints de carcinome rénal avancé (CCR) à l'aide du logiciel Carevive, une étude de faisabilité de phase II à un seul bras
Déterminer si le logiciel Carevive, qui surveille les toxicités liées au traitement et génère ensuite des plans de gestion d'auto-soins pour ces symptômes, sera réalisable chez les patients atteints d'un carcinome rénal métastatique (CCR).
De plus, pour la collecte de données préliminaires sur les toxicités liées au traitement, la qualité de vie, le niveau de détresse et l'observance des médicaments.
Aperçu de l'étude
Statut
Complété
Les conditions
Intervention / Traitement
Type d'étude
Interventionnel
Inscription (Réel)
21
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
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New York
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Rochester, New York, États-Unis, 14642
- University of Rochester - Wilmot Cancer Institute
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Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
18 ans et plus (Adulte, Adulte plus âgé)
Accepte les volontaires sains
Non
La description
Critère d'intégration:
- Diagnostic du carcinome rénal confirmé histologiquement de tout sous-type avec preuve pathologique ou radiographique de maladie métastatique
- Plus de 18 ans
- Un oncologue participant du Wilmot Cancer Center a déterminé que le candidat devrait commencer soit un traitement oral ciblé, soit une immunothérapie pour le traitement de son CCR avancé ; cela peut être pour un traitement de première intention ou pour tout traitement ultérieur.
- Capable de fournir un consentement éclairé écrit
- Maîtrise de la langue anglaise et se déclare alphabétisé
- Doit disposer d'une adresse e-mail active ou d'un accès à un appareil intelligent sur lequel des messages texte peuvent être reçus
Critère d'exclusion:
- Les femmes ne peuvent pas allaiter
- N'a pas d'accès régulier à Internet
- Impossible de venir au Wilmot Cancer Centre pour des rendez-vous tous les 3-4 mois pour des visites de routine avec leur oncologue principal
- Les sujets qui participaient auparavant à l'étude ne seront pas autorisés à se réinscrire en cas de changement de traitement.
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Soins de soutien
- Répartition: N / A
- Modèle interventionnel: Affectation à un seul groupe
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: Utilisation du logiciel Carevive
Signalement et gestion des effets secondaires d'une thérapie orale ciblée ou d'une immunothérapie, via le logiciel Carevive, chez les patients atteints d'un carcinome rénal avancé (CCR).
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Dans cette étude, Carevive fournira un lien vers les sujets afin qu'une enquête en ligne puisse être complétée.
L'enquête aura lieu chaque semaine pendant les 12 premières semaines de l'étude et sera espacée d'une semaine sur deux par la suite.
Les questions porteront principalement sur les effets secondaires de leur traitement anticancéreux, ainsi que sur quelques questions sur l'observance des médicaments et l'utilisation des soins de santé.
Une fois l'enquête terminée, le sujet recevra un plan de soins avec des options d'autogestion à domicile pour les toxicités liées aux médicaments.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Number of Participants Who Submitted at Least One Carevive Survey
Délai: From enrollment through 48 weeks
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Number of participants who completed at least one Carevive survey at any time during the 48 week study period.
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From enrollment through 48 weeks
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Percentage of Carevive Surveys Completed Per Participant
Délai: From enrollment through 48 weeks
|
Percentage of Carevive surveys completed by each participant, calculated as the number of completed surveys divided by the number of surveys prompted by the Carevive software during the 48 week study period.
|
From enrollment through 48 weeks
|
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Number of Participants Who Utilized at Least One Auto-Generated Carevive Care Plan
Délai: From enrollment through 48 weeks
|
Number of participants who accessed at least one auto-generated Carevive care plan at any time during the 48 week study period.
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From enrollment through 48 weeks
|
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Percentage of Auto Generated Carevive Care Plans Utilized Per Participant
Délai: From enrollment through 48 weeks
|
Percentage of auto generated Carevive care plans utilized by each participant, calculated as the number of care plans accessed divided by the total number of care plans generated for that participant during the 48 week study period.
|
From enrollment through 48 weeks
|
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System Usability Scale (SUS) Score for Carevive Software
Délai: From enrollment through 48 weeks
|
Participants completed the System Usability Scale (SUS), which is a validated 10-item questionnaire that produces a total usability score ranging from 0 to 100.
Scores are categorized into three main categories: excellent (>80.3 points); good (68.0 to 80.3 points) and below average (<68 points).
We calculated the SUS point for each participant who completed the survey.
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From enrollment through 48 weeks
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Functional Assessment of Cancer Therapy-Kidney Symptom Index (FKSI-DRS) Total Score
Délai: From enrollment through 48 weeks
|
The FKSI-DRS is a validated patient-reported outcome measure assessing kidney cancer-related symptoms, with total scores ranging from 0 to 36, where higher scores indicate better quality of life.
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From enrollment through 48 weeks
|
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Distress Level Assessed by NCCN Distress Thermometer
Délai: From enrollment through 48 weeks
|
The NCCN Distress Thermometer is a validated patient reported outcome measure assessing psychological distress on a scale from 0 to 10, with higher scores indicating greater distress.
Scores were categorized to reflect low distress (0-3) and moderate to severe distress (4-10).
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From enrollment through 48 weeks
|
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Health Care Utilization Assessment
Délai: From enrollment through 48 weeks
|
Health care utilization was assessed based on participant self-report and defined as having at least one hospital visit, emergency room visit, or unplanned clinic visit during the 48-week study period.
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From enrollment through 48 weeks
|
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Participants Reporting Diarrhea
Délai: From enrollment through 48 weeks
|
Number of participants who self reported Diarrhea (Yes or No) in response to PRO CTCAE survey questions assessing treatment related symptoms from oral targeted therapy or immunotherapy for advanced renal cell carcinoma.
Responses were collected using Carevive software surveys administered weekly for the first 12 weeks of the study and then every other week thereafter through 48 weeks.
Participants were counted as reporting this symptom if they answered "Yes" to the corresponding survey question during the specified time period.
|
From enrollment through 48 weeks
|
|
Participants Reporting Nausea
Délai: From enrollment through 48 weeks
|
Number of participants who self reported nausea (Yes or No) in response to PRO CTCAE survey questions assessing treatment related toxicities from oral targeted agents and immunotherapy.
Responses were collected using Carevive surveys administered weekly for the first 12 weeks and then every other week for an additional 36 weeks.
Participants were counted as reporting the symptom if they answered "Yes" to the corresponding survey question during the specified time period.
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From enrollment through 48 weeks
|
|
Participants Reporting Vomiting
Délai: From enrollment through 48 weeks
|
Number of participants who self reported vomiting (Yes or No) in response to PRO CTCAE survey questions assessing treatment related toxicities from oral targeted agents and immunotherapy.
Responses were collected using Carevive surveys administered weekly for the first 12 weeks and then every other week for an additional 36 weeks.
Participants were counted as reporting the symptom if they answered "Yes" to the corresponding survey question during the specified time period.
|
From enrollment through 48 weeks
|
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Participants Reporting Fatigue
Délai: From enrollment through 48 weeks
|
Number of participants who self reported fatigue (Yes or No) in response to PRO CTCAE survey questions assessing treatment related toxicities from oral targeted agents and immunotherapy.
Responses were collected using Carevive surveys administered weekly for the first 12 weeks and then every other week for an additional 36 weeks.
Participants were counted as reporting the symptom if they answered "Yes" to the corresponding survey question during the specified time period.
|
From enrollment through 48 weeks
|
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Participants Reporting Rash
Délai: From enrollment through 48 weeks
|
Number of participants who self reported rash (Yes or No) in response to PRO CTCAE survey questions assessing treatment related symptoms from oral targeted therapy or immunotherapy for advanced renal cell carcinoma.
Responses were collected using Carevive software surveys administered weekly for the first 12 weeks of the study and then every other week thereafter through 48 weeks.
Participants were counted as reporting the symptom if they answered "Yes" to the corresponding survey question during the specified time period.
|
From enrollment through 48 weeks
|
|
Participants Reporting Abdominal Pain
Délai: From enrollment through 48 weeks
|
Number of participants who self reported abdominal pain (Yes or No) in response to PRO CTCAE survey questions assessing treatment related symptoms from oral targeted therapy or immunotherapy for advanced renal cell carcinoma.
Responses were collected using Carevive software surveys administered weekly for the first 12 weeks of the study and then every other week thereafter through 48 weeks.
Participants were counted as reporting the symptom if they answered "Yes" to the corresponding survey question during the specified time period.
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From enrollment through 48 weeks
|
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Participants Reporting Mouth Sores
Délai: From enrollment through 48 weeks
|
Number of participants who self reported mouth sores (Yes or No) in response to PRO CTCAE survey questions assessing treatment related symptoms from oral targeted therapy or immunotherapy for advanced renal cell carcinoma.
Responses were collected using Carevive software surveys administered weekly for the first 12 weeks of the study and then every other week thereafter through 48 weeks.
Participants were counted as reporting the symptom if they answered "Yes" to the corresponding survey question during the specified time period.
|
From enrollment through 48 weeks
|
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Participants Reporting Cough
Délai: From enrollment through 48 weeks
|
Number of participants who self reported cough (Yes or No) in response to PRO CTCAE survey questions assessing treatment related symptoms from oral targeted therapy or immunotherapy for advanced renal cell carcinoma.
Responses were collected using Carevive software surveys administered weekly for the first 12 weeks of the study and then every other week thereafter through 48 weeks.
Participants were counted as reporting the symptom if they answered "Yes" to the corresponding survey question during the specified time period.
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From enrollment through 48 weeks
|
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Participants Reporting Shortness of Breath
Délai: From enrollment through 48 weeks
|
Number of participants who self reported Shortness of Breath (Yes or No) in response to PRO CTCAE survey questions assessing treatment related symptoms from oral targeted therapy or immunotherapy for advanced renal cell carcinoma.
Responses were collected using Carevive software surveys administered weekly for the first 12 weeks of the study and then every other week thereafter through 48 weeks.
Participants were counted as reporting the symptom if they answered "Yes" to the corresponding survey question during the specified time period.
|
From enrollment through 48 weeks
|
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Participants Reporting Anorexia
Délai: From enrollment through 48 weeks
|
Number of participants who self reported Anorexia (Yes or No) in response to PRO CTCAE survey questions assessing treatment related symptoms from oral targeted therapy or immunotherapy for advanced renal cell carcinoma.
Responses were collected using Carevive software surveys administered weekly for the first 12 weeks of the study and then every other week thereafter through 48 weeks.
Participants were counted as reporting this symptom if they answered "Yes" to the corresponding survey question during the specified time period.
|
From enrollment through 48 weeks
|
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Clinician Reported Diarrhea
Délai: From enrollment through 48 weeks
|
Number of participants with clinician reported diarrhea assessed during in office clinic visits while receiving oral targeted therapy or immunotherapy for advanced renal cell carcinoma.
Clinicians recorded the presence or absence of this symptom at baseline and during follow up assessments conducted from enrollment through 48 weeks.
Responses were categorized as Yes, No, or Unknown based on clinician assessment.
These data are presented as longitudinal assessments of symptom occurrence over time.
Summary reporting of these events as adverse events is provided separately in the Adverse Events section.
|
From enrollment through 48 weeks
|
|
Clinician Reported Nausea
Délai: From enrollment through 48 weeks
|
Number of participants with clinician reported nausea assessed during in office clinic visits while receiving oral targeted therapy or immunotherapy for advanced renal cell carcinoma.
Clinicians recorded the presence or absence of this symptom at baseline and during follow up assessments conducted from enrollment through 48 weeks.
Responses were categorized as Yes, No, or Unknown based on clinician assessment.
These data are presented as longitudinal assessments of symptom occurrence over time.
Summary reporting of these events as adverse events is provided separately in the Adverse Events section.
|
From enrollment through 48 weeks
|
|
Clinician Reported Vomiting
Délai: From enrollment through 48 weeks
|
Number of participants with clinician reported vomiting assessed during in office clinic visits while receiving oral targeted therapy or immunotherapy for advanced renal cell carcinoma.
Clinicians recorded the presence or absence of this symptom at baseline and during follow up assessments conducted from enrollment through 48 weeks.
Responses were categorized as Yes, No, or Unknown based on clinician assessment.
These data are presented as longitudinal assessments of symptom occurrence over time.
Summary reporting of these events as adverse events is provided separately in the Adverse Events section.
|
From enrollment through 48 weeks
|
|
Clinician Reported Fatigue
Délai: From enrollment through 48 weeks
|
Number of participants with clinician reported fatigue assessed during in office clinic visits while receiving oral targeted therapy or immunotherapy for advanced renal cell carcinoma.
Clinicians recorded the presence or absence of this symptom at baseline and during follow up assessments conducted from enrollment through 48 weeks.
Responses were categorized as Yes, No, or Unknown based on clinician assessment.
These data are presented as longitudinal assessments of symptom occurrence over time.
Summary reporting of these events as adverse events is provided separately in the Adverse Events section.
|
From enrollment through 48 weeks
|
|
Clinician Reported Rash
Délai: From enrollment through 48 weeks
|
Number of participants with clinician reported Rash assessed during in office clinic visits while receiving oral targeted therapy or immunotherapy for advanced renal cell carcinoma.
Clinicians recorded the presence or absence of this symptom at baseline and during follow up assessments conducted from enrollment through 48 weeks.
Responses were categorized as Yes, No, or Unknown based on clinician assessment.
These data are presented as longitudinal assessments of symptom occurrence over time.
Summary reporting of these events as adverse events is provided separately in the Adverse Events section.
|
From enrollment through 48 weeks
|
|
Clinician Reported Abdominal Pain
Délai: From enrollment through 48 weeks
|
Number of participants with clinician reported Abdominal Pain assessed during in office clinic visits while receiving oral targeted therapy or immunotherapy for advanced renal cell carcinoma.
Clinicians recorded the presence or absence of this symptom at baseline and during follow up assessments conducted from enrollment through 48 weeks.
Responses were categorized as Yes, No, or Unknown based on clinician assessment.
These data are presented as longitudinal assessments of symptom occurrence over time.
Summary reporting of these events as adverse events is provided separately in the Adverse Events section.
|
From enrollment through 48 weeks
|
|
Clinician Reported Mouth Sores
Délai: From enrollment through 48 weeks
|
Number of participants with clinician reported Mouth Sores assessed during in office clinic visits while receiving oral targeted therapy or immunotherapy for advanced renal cell carcinoma.
Clinicians recorded the presence or absence of this symptom at baseline and during follow up assessments conducted from enrollment through 48 weeks.
Responses were categorized as Yes, No, or Unknown based on clinician assessment.
These data are presented as longitudinal assessments of symptom occurrence over time.
Summary reporting of these events as adverse events is provided separately in the Adverse Events section.
|
From enrollment through 48 weeks
|
|
Clinician Reported Cough
Délai: From enrollment through 48 weeks
|
Number of participants with clinician reported Cough assessed during in office clinic visits while receiving oral targeted therapy or immunotherapy for advanced renal cell carcinoma.
Clinicians recorded the presence or absence of this symptom at baseline and during follow up assessments conducted from enrollment through 48 weeks.
Responses were categorized as Yes, No, or Unknown based on clinician assessment.
These data are presented as longitudinal assessments of symptom occurrence over time.
Summary reporting of these events as adverse events is provided separately in the Adverse Events section.
|
From enrollment through 48 weeks
|
|
Clinician Reported Shortness of Breath
Délai: From enrollment through 48 weeks
|
Number of participants with clinician reported Shortness of Breath assessed during in office clinic visits while receiving oral targeted therapy or immunotherapy for advanced renal cell carcinoma.
Clinicians recorded the presence or absence of this symptom at baseline and during follow up assessments conducted from enrollment through 48 weeks.
Responses were categorized as Yes, No, or Unknown based on clinician assessment.
These data are presented as longitudinal assessments of symptom occurrence over time.
Summary reporting of these events as adverse events is provided separately in the Adverse Events section.
|
From enrollment through 48 weeks
|
|
Clinician Reported Anorexia
Délai: From enrollment through 48 weeks
|
Number of participants with clinician reported Anorexia assessed during in office clinic visits while receiving oral targeted therapy or immunotherapy for advanced renal cell carcinoma.
Clinicians recorded the presence or absence of this symptom at baseline and during follow up assessments conducted from enrollment through 48 weeks.
Responses were categorized as Yes, No, or Unknown based on clinician assessment.
These data are presented as longitudinal assessments of symptom occurrence over time.
Summary reporting of these events as adverse events is provided separately in the Adverse Events section.
|
From enrollment through 48 weeks
|
Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Collaborateurs
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Réel)
24 juillet 2019
Achèvement primaire (Réel)
14 février 2025
Achèvement de l'étude (Réel)
14 février 2025
Dates d'inscription aux études
Première soumission
18 juillet 2017
Première soumission répondant aux critères de contrôle qualité
24 juillet 2017
Première publication (Réel)
25 juillet 2017
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
7 mai 2026
Dernière mise à jour soumise répondant aux critères de contrôle qualité
15 avril 2026
Dernière vérification
1 février 2025
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
- Maladies urogénitales
- Tumeurs urogénitales
- Tumeurs par site
- Tumeurs
- Maladies urogénitales masculines
- Maladies rénales
- Maladies urologiques
- Maladies urogénitales féminines
- Maladies urogénitales féminines et complications de la grossesse
- Tumeurs par type histologique
- Tumeurs, glandulaires et épithéliales
- Adénocarcinome
- Tumeurs urologiques
- Tumeurs rénales
- Carcinome
- Carcinome à cellules rénales
Autres numéros d'identification d'étude
- UGUK 17036
- UG1CA189961 (Subvention/contrat des NIH des États-Unis)
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
NON
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
produit fabriqué et exporté des États-Unis.
Non
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .
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