Softwareovervågning af behandlingsrelaterede toksiciteter ved avanceret nyrecellekarcinom
Overvågning af behandlingsrelaterede toksiciteter fra orale målrettede midler og immunterapi blandt patienter med avanceret nyrecellekarcinom (RCC) ved hjælp af Carevive-software, en enkeltarms fase II-gennemførlighedsundersøgelse
Studieoversigt
Status
Status
Betingelser
Betingelser
Intervention / Behandling
Intervention / Behandling
Undersøgelsestype
Undersøgelsestype
Tilmelding (Faktiske)
Tilmelding
Fase
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
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New York
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Rochester, New York, Forenede Stater, 14642
- University of Rochester - Wilmot Cancer Institute
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Deltagelseskriterier
Berettigelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Beskrivelse
Inklusionskriterier:
- Diagnose af histologisk bekræftet nyrecellekarcinom af enhver undertype med enten patologisk eller radiografisk tegn på metastatisk sygdom
- Over 18 år
- En deltagende Wilmot Cancer Center-onkolog har bestemt, at kandidaten skal startes på enten oral målrettet terapi eller immunterapi til behandling af deres fremskredne RCC; dette kan være til førstelinjebehandling eller enhver efterfølgende linjebehandling
- Kan give skriftligt informeret samtykke
- Færdig i det engelske sprog og selvrapporterer som literate
- Skal have en aktiv e-mailadresse eller adgang til en smartenhed, hvorpå der kan modtages sms'er
Ekskluderingskriterier:
- Kvinder kan ikke amme
- Har ikke regelmæssig adgang til internettet
- Ude af stand til at komme til Wilmot Cancer Center for aftaler hver 3-4 måned for rutinebesøg hos deres primære onkolog
- Forsøgspersoner, der tidligere var i undersøgelsen, vil ikke få lov til at gentilmelde sig i tilfælde af en behandlingsændring
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Støttende pleje
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Antal våben
Våben og indgreb
Deltagergruppe / ArmDeltagergruppe / Arm |
Intervention / BehandlingIntervention / Behandling |
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Eksperimentel: Brug af Carevive-software
Rapportering og håndtering af bivirkninger fra oral målrettet behandling eller immunterapi, gennem Carevive-software, hos patienter, som har fremskreden nyrecellekarcinom (RCC).
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I denne undersøgelse vil Carevive levere et link til emner, så en online-undersøgelse kan udfyldes.
Undersøgelsen vil finde sted ugentligt i de første 12 uger af undersøgelsen og vil derefter blive fordelt hver anden uge.
Spørgsmålene vil for det meste fokusere på bivirkninger fra deres kræftbehandling, samt et par spørgsmål om lægemiddeloverholdelse og sundhedsanvendelse.
Efter afslutning af undersøgelsen vil forsøgspersonen få en plejeplan med mulighed for selvstyring i hjemmet for lægemiddelrelaterede toksiciteter.
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Hvad måler undersøgelsen?
Primære resultatmål
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Number of Participants Who Submitted at Least One Carevive Survey
Tidsramme: 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
Tidsramme: From enrollment through 48 weeks
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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.
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From enrollment through 48 weeks
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Number of Participants Who Utilized at Least One Auto-Generated Carevive Care Plan
Tidsramme: From enrollment through 48 weeks
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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
Tidsramme: From enrollment through 48 weeks
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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.
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From enrollment through 48 weeks
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System Usability Scale (SUS) Score for Carevive Software
Tidsramme: From enrollment through 48 weeks
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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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Sekundære resultatmål
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Functional Assessment of Cancer Therapy-Kidney Symptom Index (FKSI-DRS) Total Score
Tidsramme: From enrollment through 48 weeks
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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
Tidsramme: From enrollment through 48 weeks
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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
Tidsramme: From enrollment through 48 weeks
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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
Tidsramme: From enrollment through 48 weeks
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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.
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From enrollment through 48 weeks
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Participants Reporting Nausea
Tidsramme: From enrollment through 48 weeks
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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
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Participants Reporting Vomiting
Tidsramme: From enrollment through 48 weeks
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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.
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From enrollment through 48 weeks
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Participants Reporting Fatigue
Tidsramme: From enrollment through 48 weeks
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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.
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From enrollment through 48 weeks
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Participants Reporting Rash
Tidsramme: From enrollment through 48 weeks
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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.
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From enrollment through 48 weeks
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Participants Reporting Abdominal Pain
Tidsramme: From enrollment through 48 weeks
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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
Tidsramme: From enrollment through 48 weeks
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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.
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From enrollment through 48 weeks
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Participants Reporting Cough
Tidsramme: From enrollment through 48 weeks
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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
Tidsramme: From enrollment through 48 weeks
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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.
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From enrollment through 48 weeks
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Participants Reporting Anorexia
Tidsramme: From enrollment through 48 weeks
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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.
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From enrollment through 48 weeks
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Clinician Reported Diarrhea
Tidsramme: From enrollment through 48 weeks
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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.
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From enrollment through 48 weeks
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Clinician Reported Nausea
Tidsramme: From enrollment through 48 weeks
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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.
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From enrollment through 48 weeks
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Clinician Reported Vomiting
Tidsramme: From enrollment through 48 weeks
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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.
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From enrollment through 48 weeks
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Clinician Reported Fatigue
Tidsramme: From enrollment through 48 weeks
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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.
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From enrollment through 48 weeks
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Clinician Reported Rash
Tidsramme: From enrollment through 48 weeks
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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.
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From enrollment through 48 weeks
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Clinician Reported Abdominal Pain
Tidsramme: From enrollment through 48 weeks
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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.
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From enrollment through 48 weeks
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Clinician Reported Mouth Sores
Tidsramme: From enrollment through 48 weeks
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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.
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From enrollment through 48 weeks
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Clinician Reported Cough
Tidsramme: From enrollment through 48 weeks
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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.
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From enrollment through 48 weeks
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Clinician Reported Shortness of Breath
Tidsramme: From enrollment through 48 weeks
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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.
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From enrollment through 48 weeks
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Clinician Reported Anorexia
Tidsramme: From enrollment through 48 weeks
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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.
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From enrollment through 48 weeks
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Samarbejdspartnere og efterforskere
Sponsor
Sponsor
Samarbejdspartnere
Samarbejdspartnere
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Studiestart
Primær færdiggørelse (Faktiske)
Primær færdiggørelse
Studieafslutning (Faktiske)
Studieafslutning
Datoer for studieregistrering
Først indsendt
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Først opslået
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering sendt
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
- Urogenitale sygdomme
- Urogenitale neoplasmer
- Neoplasmer efter sted
- Neoplasmer
- Mandlige urogenitale sygdomme
- Nyresygdomme
- Urologiske sygdomme
- Urogenitale sygdomme hos kvinder
- Kvinders urogenitale sygdomme og graviditetskomplikationer
- Neoplasmer efter histologisk type
- Neoplasmer, kirtel og epitel
- Adenocarcinom
- Urologiske neoplasmer
- Nyre-neoplasmer
- Karcinom
- Karcinom, nyrecelle
Andre undersøgelses-id-numre
Andre undersøgelses-id-numre
- UGUK 17036
- UG1CA189961 (U.S. NIH-bevilling/kontrakt)
Plan for individuelle deltagerdata (IPD)
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