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Programvaruövervakning av behandlingsrelaterade toxiciteter vid avancerad njurcellscancer

15 april 2026 uppdaterad av: Chunkit Fung, University of Rochester

Övervakning av behandlingsrelaterade toxiciteter från orala målinriktade medel och immunterapi bland patienter med avancerad njurcellscancer (RCC) med hjälp av Carevive Software, en enarmsfas II genomförbarhetsstudie

För att avgöra om programvaran Carevive, som övervakar behandlingsrelaterade toxiciteter och sedan genererar egenvårdsplaner för dessa symtom, kommer att vara möjlig att implementera bland patienter med metastaserande njurcellscancer (RCC). Dessutom för insamling av preliminära data om behandlingsrelaterade toxiciteter, livskvalitet, nödnivå och drogadherens.

Studieöversikt

Status

Avslutad

Betingelser

Intervention / Behandling

Studietyp

Interventionell

Inskrivning (Faktisk)

21

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

  • Förenta staterna
    • New York
      • Rochester, New York, Förenta staterna, 14642
        • University of Rochester - Wilmot Cancer Institute

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år och äldre (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Beskrivning

Inklusionskriterier:

  • Diagnos av histologiskt bekräftat njurcellscancer av någon subtyp med antingen patologiska eller radiografiska bevis på metastaserande sjukdom
  • Över 18 år
  • En deltagande Wilmot Cancer Center-onkolog har bestämt att kandidaten bör inledas med antingen oral riktad terapi eller immunterapi för behandling av deras avancerade RCC; detta kan vara för första linjens eller någon efterföljande linjebehandling
  • Kan ge skriftligt informerat samtycke
  • Behärskar engelska språket och självrapporterar som läskunnig
  • Måste ha en aktiv e-postadress eller tillgång till en smart enhet som textmeddelanden kan tas emot på

Exklusions kriterier:

  • Kvinnor kan inte amma
  • Har inte regelbunden tillgång till internet
  • Kan inte komma till Wilmot Cancer Center för möten var 3-4 månad för rutinbesök med sin primära onkolog
  • Försökspersoner som deltog i studien tidigare kommer inte att tillåtas att återregistrera sig vid en behandlingsändring

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Stödjande vård
  • Tilldelning: N/A
  • Interventionsmodell: Enskild gruppuppgift
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: Användning av programvaran Carevive
Rapportering och hantering av biverkningar från oral riktad terapi eller immunterapi, genom programvaran Carevive, hos patienter som har avancerad njurcellscancer (RCC).
Övrig: Careive programvara
I denna studie kommer Carevive att leverera en länk till ämnen så att en onlineenkät kan fyllas i. Undersökningen kommer att ske varje vecka under de första 12 veckorna av studien och kommer därefter att fördelas ut till varannan vecka. Frågorna kommer mestadels att fokusera på biverkningar från deras cancerbehandling, samt några frågor om läkemedelsefterlevnad och sjukvårdsanvändning. Efter genomförd undersökning kommer försökspersonen att få en vårdplan med självhanteringsalternativ hemma för läkemedelsrelaterade toxiciteter.

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Number of Participants Who Submitted at Least One Carevive Survey
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Functional Assessment of Cancer Therapy-Kidney Symptom Index (FKSI-DRS) Total Score
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

University of Rochester

Samarbetspartners

National Cancer Institute (NCI)

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

24 juli 2019

Primärt slutförande (Faktisk)

14 februari 2025

Avslutad studie (Faktisk)

14 februari 2025

Studieregistreringsdatum

Först inskickad

18 juli 2017

Först inskickad som uppfyllde QC-kriterierna

24 juli 2017

Första postat (Faktisk)

25 juli 2017

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

7 maj 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

15 april 2026

Senast verifierad

1 februari 2025

Mer information

Termer relaterade till denna studie

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • UGUK 17036
  • UG1CA189961 (U.S.S. NIH-anslag/kontrakt)

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

NEJ

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Nej

Studerar en amerikansk FDA-reglerad produktprodukt

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produkt tillverkad i och exporterad från U.S.A.

Nej

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

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