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Softwarové monitorování toxických látek souvisejících s léčbou u pokročilého renálního buněčného karcinomu

15. dubna 2026 aktualizováno: Chunkit Fung, University of Rochester

Monitorování toxických účinků perorálních cílených látek a imunoterapie u pacientů s pokročilým renálním karcinomem (RCC) pomocí softwaru Carevive, jednoramenné studie proveditelnosti fáze II

Určení, zda software Carevive, který monitoruje toxicitu související s léčbou a poté generuje plány péče o sebe sama pro tyto symptomy, bude možné implementovat u pacientů s metastatickým karcinomem ledviny (RCC). Kromě toho pro sběr předběžných údajů o toxicitě související s léčbou, kvalitě života, míře úzkosti a adherenci k lékům.

Přehled studie

Postavení

Dokončeno

Podmínky

Intervence / Léčba

Typ studie

Intervenční

Zápis (Aktuální)

21

Fáze

  • Nelze použít

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní místa

  • Spojené státy
    • New York
      • Rochester, New York, Spojené státy, 14642
        • University of Rochester - Wilmot Cancer Institute

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

18 let a starší (Dospělý, Starší dospělý)

Přijímá zdravé dobrovolníky

Ne

Popis

Kritéria pro zařazení:

  • Diagnostika histologicky potvrzeného renálního karcinomu jakéhokoli podtypu s patologickým nebo rentgenovým průkazem metastatického onemocnění
  • Věk starší 18 let
  • Zúčastněný onkolog Wilmot Cancer Center rozhodl, že kandidát by měl začít buď s perorální cílenou terapií, nebo s imunoterapií pro léčbu pokročilého RCC; to může být pro terapii první linie nebo jakoukoli následnou terapii
  • Schopnost poskytnout písemný informovaný souhlas
  • Ovládat anglický jazyk a sám se hlásit jako gramotný
  • Musíte mít aktivní e-mailovou adresu nebo přístup k chytrému zařízení, na kterém lze přijímat textové zprávy

Kritéria vyloučení:

  • Ženy nemohou kojit
  • Nemá pravidelný přístup k internetu
  • Nemůže docházet do Wilmot Cancer Center na schůzky každé 3-4 měsíce na rutinní návštěvy u svého primárního onkologa
  • Subjektům, které byly ve studii dříve, nebude umožněno se znovu zapsat v případě změny léčby

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Podpůrná péče
  • Přidělení: N/A
  • Intervenční model: Přiřazení jedné skupiny
  • Maskování: Žádné (otevřený štítek)

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Experimentální: Použití softwaru Carevive
Hlášení a řízení vedlejších účinků perorální cílené terapie nebo imunoterapie prostřednictvím softwaru Carevive u pacientů s pokročilým renálním buněčným karcinomem (RCC).
Jiný: Software Carevive
V této studii Carevive poskytne odkaz na subjekty, aby bylo možné dokončit online průzkum. Průzkum bude probíhat týdně po dobu prvních 12 týdnů studie a poté bude rozložen na každý další týden. Otázky se většinou zaměří na vedlejší účinky jejich léčby rakoviny a také na několik otázek o dodržování léků a využívání zdravotní péče. Po dokončení průzkumu bude subjektu poskytnut plán péče s možnostmi domácí samosprávy pro toxicitu související s drogami.

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Number of Participants Who Submitted at Least One Carevive Survey
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Functional Assessment of Cancer Therapy-Kidney Symptom Index (FKSI-DRS) Total Score
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

University of Rochester

Spolupracovníci

National Cancer Institute (NCI)

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Aktuální)

24. července 2019

Primární dokončení (Aktuální)

14. února 2025

Dokončení studie (Aktuální)

14. února 2025

Termíny zápisu do studia

První předloženo

18. července 2017

První předloženo, které splnilo kritéria kontroly kvality

24. července 2017

První zveřejněno (Aktuální)

25. července 2017

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

7. května 2026

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

15. dubna 2026

Naposledy ověřeno

1. února 2025

Více informací

Termíny související s touto studií

Další relevantní podmínky MeSH

Další identifikační čísla studie

  • UGUK 17036
  • UG1CA189961 (Grant/smlouva NIH USA)

Plán pro data jednotlivých účastníků (IPD)

Plánujete sdílet data jednotlivých účastníků (IPD)?

NE

Informace o lécích a zařízeních, studijní dokumenty

Studuje lékový produkt regulovaný americkým FDA

Ne

Studuje produkt zařízení regulovaný americkým úřadem FDA

Ne

produkt vyrobený a vyvážený z USA

Ne

Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .

Klinické studie na Pokročilý renální buněčný karcinom

Klinické studie na Software Carevive

Prohledejte podobné pokusy

Sponzoři a spolupracovníci

Zdravotní podmínky

Drogové intervence

CROs by country

CROs in Guinea

Podmínky

Vzácné nemoci

Drogové intervence

Doplňky stravy

Sponzor / Spolupracovníci

Místa

Předplatit