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Softwareüberwachung behandlungsbedingter Toxizitäten bei fortgeschrittenem Nierenzellkarzinom

15. April 2026 aktualisiert von: Chunkit Fung, University of Rochester

Überwachung behandlungsbedingter Toxizitäten durch orale zielgerichtete Wirkstoffe und Immuntherapie bei Patienten mit fortgeschrittenem Nierenzellkarzinom (RCC) mithilfe der Carevive-Software, einer einarmigen Phase-II-Machbarkeitsstudie

Es soll ermittelt werden, ob die Carevive-Software, die behandlungsbedingte Toxizitäten überwacht und dann Selbstpflege-Managementpläne für diese Symptome erstellt, bei Patienten mit metastasiertem Nierenzellkarzinom (RCC) implementiert werden kann. Zusätzlich zur Erhebung vorläufiger Daten zu behandlungsbedingten Toxizitäten, Lebensqualität, Stressniveau und Medikamenteneinhaltung.

Studienübersicht

Status

Abgeschlossen

Bedingungen

Intervention / Behandlung

Studientyp

Interventionell

Einschreibung (Tatsächlich)

21

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

  • Vereinigte Staaten
    • New York
      • Rochester, New York, Vereinigte Staaten, 14642
        • University of Rochester - Wilmot Cancer Institute

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

18 Jahre und älter (Erwachsene, Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Nein

Beschreibung

Einschlusskriterien:

  • Diagnose eines histologisch bestätigten Nierenzellkarzinoms jeglichen Subtyps mit pathologischen oder radiologischen Hinweisen auf eine metastatische Erkrankung
  • Mehr als 18 Jahre alt
  • Ein teilnehmender Onkologe des Wilmot Cancer Center hat entschieden, dass der Kandidat entweder mit einer oralen gezielten Therapie oder einer Immuntherapie zur Behandlung seines fortgeschrittenen RCC beginnen sollte; Dies kann für die Erstlinientherapie oder jede Folgelinientherapie gelten
  • Kann eine schriftliche Einverständniserklärung abgeben
  • Beherrscht die englische Sprache und bezeichnet sich selbst als gebildet
  • Sie müssen über eine aktive E-Mail-Adresse oder Zugriff auf ein Smart-Gerät verfügen, auf dem Textnachrichten empfangen werden können

Ausschlusskriterien:

  • Frauen können nicht stillen
  • Hat keinen regelmäßigen Zugang zum Internet
  • Es ist nicht möglich, alle drei bis vier Monate für Routinebesuche bei ihrem primären Onkologen ins Wilmot Cancer Center zu kommen
  • Probanden, die zuvor an der Studie teilgenommen haben, dürfen sich im Falle einer Behandlungsänderung nicht erneut einschreiben

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Unterstützende Pflege
  • Zuteilung: N / A
  • Interventionsmodell: Einzelgruppenzuweisung
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: Verwendung der Carevive-Software
Meldung und Management von Nebenwirkungen einer oralen gezielten Therapie oder Immuntherapie mithilfe der Carevive-Software bei Patienten mit fortgeschrittenem Nierenzellkarzinom (RCC).
Sonstiges: Carevive-Software
In dieser Studie stellt Carevive einen Link zu den Probanden bereit, damit eine Online-Umfrage ausgefüllt werden kann. Die Befragung findet in den ersten 12 Wochen der Studie wöchentlich statt und wird danach alle zwei Wochen durchgeführt. Die Fragen konzentrieren sich hauptsächlich auf Nebenwirkungen ihrer Krebstherapie sowie auf einige Fragen zur Medikamenteneinhaltung und zur Inanspruchnahme der Gesundheitsversorgung. Nach Abschluss der Umfrage erhält der Proband einen Pflegeplan mit Möglichkeiten zur Selbstbehandlung von arzneimittelbedingten Toxizitäten zu Hause.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Number of Participants Who Submitted at Least One Carevive Survey
Zeitfenster: From enrollment through 48 weeks
Number of participants who completed at least one Carevive survey at any time during the 48 week study period.
From enrollment through 48 weeks
Percentage of Carevive Surveys Completed Per Participant
Zeitfenster: 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
Number of Participants Who Utilized at Least One Auto-Generated Carevive Care Plan
Zeitfenster: 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.
From enrollment through 48 weeks
Percentage of Auto Generated Carevive Care Plans Utilized Per Participant
Zeitfenster: 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
System Usability Scale (SUS) Score for Carevive Software
Zeitfenster: 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.
From enrollment through 48 weeks

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Functional Assessment of Cancer Therapy-Kidney Symptom Index (FKSI-DRS) Total Score
Zeitfenster: 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.
From enrollment through 48 weeks
Distress Level Assessed by NCCN Distress Thermometer
Zeitfenster: 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).
From enrollment through 48 weeks
Health Care Utilization Assessment
Zeitfenster: 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.
From enrollment through 48 weeks
Participants Reporting Diarrhea
Zeitfenster: 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
Zeitfenster: 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.
From enrollment through 48 weeks
Participants Reporting Vomiting
Zeitfenster: 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
Participants Reporting Fatigue
Zeitfenster: 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
Participants Reporting Rash
Zeitfenster: 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
Zeitfenster: 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.
From enrollment through 48 weeks
Participants Reporting Mouth Sores
Zeitfenster: 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
Participants Reporting Cough
Zeitfenster: 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.
From enrollment through 48 weeks
Participants Reporting Shortness of Breath
Zeitfenster: 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
Participants Reporting Anorexia
Zeitfenster: 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
Clinician Reported Diarrhea
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

University of Rochester

Mitarbeiter

National Cancer Institute (NCI)

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

24. Juli 2019

Primärer Abschluss (Tatsächlich)

14. Februar 2025

Studienabschluss (Tatsächlich)

14. Februar 2025

Studienanmeldedaten

Zuerst eingereicht

18. Juli 2017

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

24. Juli 2017

Zuerst gepostet (Tatsächlich)

25. Juli 2017

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

7. Mai 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

15. April 2026

Zuletzt verifiziert

1. Februar 2025

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • UGUK 17036
  • UG1CA189961 (US NIH Stipendium/Vertrag)

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

NEIN

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Produkt, das in den USA hergestellt und aus den USA exportiert wird

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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