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| ID | Type | Description | Link |
|---|---|---|---|
| UG1CA189961 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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To determine if Carevive software, which monitors treatment-related toxicities and then generates self-care management plans for these symptoms, will be feasible to implement among patients with metastatic renal cell carcinoma (RCC). Additionally for collection of preliminary data on treatment-related toxicities, quality of life, distress level, and drug adherence.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Use of Carevive software | Experimental | Reporting and management of side effects from oral targeted therapy or immunotherapy, through Carevive software, in patients who have advanced Renal Cell Carcinoma (RCC). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Carevive software | Other | In this study, Carevive will deliver a link to subjects so that an online survey can be completed. The survey will occur weekly for the first 12 weeks of the study and will be spaced out to every other week thereafter. The questions will mostly focus on side effects from their cancer therapy, as well as a few questions about drug compliance and healthcare utilization. After completion of the survey, the subject will be given a care plan with at home self-management options for drug-related toxicities. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Who Submitted at Least One Carevive Survey | 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 | 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 | 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 | 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 | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Functional Assessment of Cancer Therapy-Kidney Symptom Index (FKSI-DRS) Total Score | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Rochester - Wilmot Cancer Institute | Rochester | New York | 14642 | United States |
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Twenty one participants provided informed consent, met eligibility criteria, and were assigned to the Carevive Software Program arm.
The study coordinators and investigators reviewed medical records of patients undergoing treatment for advanced renal cell carcinoma to identify patients who meet eligibility criteria for clinical study. Potential eligible participants were then approached by study team at next scheduled clinic follow up visit to discuss their interests in participation in the study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Use of Carevive Software | Participants in the Carevive software program received an online survey using the Carevive software program weekly for the first 12 weeks of the study, and then every other week thereafter. The survey asked participants about side effects from their cancer therapy. Based on answers to this survey, an automatically generated care plan with at home self-management options for drug-related toxicities was provided to participants. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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Twenty-one participants consented to participate in the study and were assigned to the Carevive Software Program study arm. Baseline characteristics are reported for participants with available data; missing data were not imputed.
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| ID | Title | Description |
|---|---|---|
| BG000 | Use of Carevive Software | Participants in the Carevive software program received an online survey using the Carevive software program weekly for the first 12 weeks of the study, and then every other week thereafter. The survey focused on side effects from participants' cancer therapy. Based on answers to this survey, an automatically generated care plan with at home self-management options for drug-related toxicities was provided to participants. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Age in years |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants Who Submitted at Least One Carevive Survey | Number of participants who completed at least one Carevive survey at any time during the 48 week study period. | This analysis includes the twenty-one participants assigned to the Carevive Software Program study arm | Posted | Count of Participants | Participants | From enrollment through 48 weeks |
|
From enrollment through 48 weeks
Adverse events were systematically assessed during in-office clinical visits and included clinician-reported toxicities during standard of care oncology treatment. All-cause mortality, serious adverse events, and other adverse events were assessed for all enrolled participants. The Carevive software is a supportive care intervention, and no adverse events or serious adverse events were attributed to the software.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Use of Carevive Software | Participants in the Carevive software program received an online survey using the Carevive software program weekly for the first 12 weeks of the study, and then every other week thereafter. The survey focused on side effects from participants' cancer therapy. Based on answers to this survey, an automatically generated care plan with at home self-management options for drug-related toxicities was provided to participants. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhea | Gastrointestinal disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chunkit Fung | University of Rochester | 5852756526 | chunkit_fung@urmc.rochester.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 23, 2020 | Jan 23, 2026 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jan 27, 2020 | Jan 23, 2026 | ICF_001.pdf |
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|
| Distress Level Assessed by NCCN Distress Thermometer |
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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 |
| Participants |
|
| Sex/Gender, Customized | Two subjects did not provide data for sex/gender. | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Marital Status | Two participants did not provide data for marital status | Count of Participants | Participants |
|
| Employment Status | Four participants did not provide data for employment status | Count of Participants | Participants |
|
| Educational Level | Six participants did not provide data for educational level | Count of Participants | Participants |
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| Health Rating | Six participants did not provide data for health rating | Count of Participants | Participants |
|
| Ever Smoked Cigarettes | Five participants did not provide data for this question | Count of Participants | Participants |
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| Total Years Smoked Cigarettes | Thirteen participants did not provide data for this question | Median | Full Range | Years |
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| Currently Smoke Cigarettes | Five participants did not provide data for this question | Count of Participants | Participants |
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| Number of days within a week that participants consume alcohol | Six participants did not provide data for this question | Count of Participants | Participants |
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|
| Primary | Percentage of Carevive Surveys Completed Per Participant | 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. | This analysis includes the thirteen participants who completed at least one Carevive surveys during the study period. | Posted | Median | Full Range | Percent | From enrollment through 48 weeks | Surveys | Surveys |
|
|
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| Primary | Number of Participants Who Utilized at Least One Auto-Generated Carevive Care Plan | Number of participants who accessed at least one auto-generated Carevive care plan at any time during the 48 week study period. | This analysis includes the twenty-one participants assigned to the Carevive Software Program study arm. | Posted | Count of Participants | Participants | From enrollment through 48 weeks |
|
|
|
| Primary | Percentage of Auto Generated Carevive Care Plans Utilized Per Participant | 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. | This analysis includes the thirteen participants who completed at least one Carevive survey and therefore had care plans generated during the study period. | Posted | Median | Full Range | Percent | From enrollment through 48 weeks | Careplan | Careplan |
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| Primary | System Usability Scale (SUS) Score for Carevive Software | 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. | This analysis includes the 8 participants who completed the System Usability Scale during the study. | Posted | Count of Participants | Participants | From enrollment through 48 weeks |
|
|
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| Secondary | Functional Assessment of Cancer Therapy-Kidney Symptom Index (FKSI-DRS) Total Score | 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. | This analysis includes the twenty participants who completed the FKSI-DRS at one or more study assessment time points. | Posted | Median | Full Range | points | From enrollment through 48 weeks |
|
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| Secondary | Distress Level Assessed by NCCN Distress Thermometer | 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). | This analysis includes the twenty participants with available NCCN Distress Thermometer data at one or more study assessment time points. | Posted | Count of Participants | Participants | From enrollment through 48 weeks |
|
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| Secondary | Health Care Utilization Assessment | 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. | This analysis includes the thirteen participants with available health care utilization data. | Posted | Count of Participants | Participants | From enrollment through 48 weeks |
|
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| Secondary | Participants Reporting Diarrhea | 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. | This analysis includes the thirteen participants who completed at least one Carevive survey during the study period. | Posted | Count of Participants | Participants | From enrollment through 48 weeks |
|
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| Secondary | Participants Reporting Nausea | 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. | This analysis includes the thirteen participants who completed at least one Carevive survey during the study period. | Posted | Count of Participants | Participants | From enrollment through 48 weeks |
|
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| Secondary | Participants Reporting Vomiting | 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. | This analysis includes the thirteen participants who completed at least one Carevive survey during the study period. | Posted | Count of Participants | Participants | From enrollment through 48 weeks |
|
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| Secondary | Participants Reporting Fatigue | 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. | This analysis includes the thirteen participants who completed at least one Carevive survey during the study period. | Posted | Count of Participants | Participants | From enrollment through 48 weeks |
|
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| Secondary | Participants Reporting Rash | 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. | This analysis includes the thirteen participants who completed at least one Carevive survey during the study period. | Posted | Count of Participants | Participants | From enrollment through 48 weeks |
|
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| Secondary | Participants Reporting Abdominal Pain | 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. | This analysis includes the thirteen participants who completed at least one Carevive survey during the study period. | Posted | Count of Participants | Participants | From enrollment through 48 weeks |
|
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| Secondary | Participants Reporting Mouth Sores | 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. | This analysis includes the thirteen participants who completed at least one Carevive survey during the study period. | Posted | Count of Participants | Participants | From enrollment through 48 weeks |
|
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| Secondary | Participants Reporting Cough | 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. | This analysis includes the thirteen participants who completed at least one Carevive survey during the study period. | Posted | Count of Participants | Participants | From enrollment through 48 weeks |
|
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| Secondary | Participants Reporting Shortness of Breath | 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. | This analysis includes the thirteen participants who completed at least one Carevive survey during the study period. | Posted | Count of Participants | Participants | From enrollment through 48 weeks |
|
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| Secondary | Participants Reporting Anorexia | 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. | This analysis includes the thirteen participants who completed at least one Carevive survey during the study period. | Posted | Count of Participants | Participants | From enrollment through 48 weeks |
|
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| Secondary | Clinician Reported Diarrhea | 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. | This analysis includes the twenty participants with available data at one or more study assessment time points at clinic office visit. | Posted | Count of Participants | Participants | From enrollment through 48 weeks |
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| Secondary | Clinician Reported Nausea | 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. | This analysis includes the twenty participants with available data at one or more study assessment time points at clinic office visit. | Posted | Count of Participants | Participants | From enrollment through 48 weeks |
|
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| Secondary | Clinician Reported Vomiting | 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. | This analysis includes the twenty participants with available data at one or more study assessment time points at clinic office visit. | Posted | Count of Participants | Participants | From enrollment through 48 weeks |
|
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| Secondary | Clinician Reported Fatigue | 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. | This analysis includes the twenty participants with available data at one or more study assessment time points at clinic office visit. | Posted | Count of Participants | Participants | From enrollment through 48 weeks |
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| Secondary | Clinician Reported Rash | 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. | This analysis includes the twenty participants with available data at one or more study assessment time points at clinic office visit. | Posted | Count of Participants | Participants | From enrollment through 48 weeks |
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| Secondary | Clinician Reported Abdominal Pain | 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. | This analysis includes the twenty participants with available data at one or more study assessment time points at clinic office visit. | Posted | Count of Participants | Participants | From enrollment through 48 weeks |
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| Secondary | Clinician Reported Mouth Sores | 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. | This analysis includes the twenty participants with available data at one or more study assessment time points at clinic office visit. | Posted | Count of Participants | Participants | From enrollment through 48 weeks |
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|
|
| Secondary | Clinician Reported Cough | 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. | This analysis includes the twenty participants with available data at one or more study assessment time points at clinic office visit. | Posted | Count of Participants | Participants | From enrollment through 48 weeks |
|
|
|
| Secondary | Clinician Reported Shortness of Breath | 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. | This analysis includes the twenty participants with available data at one or more study assessment time points at clinic office visit. | Posted | Count of Participants | Participants | From enrollment through 48 weeks |
|
|
|
| Secondary | Clinician Reported Anorexia | 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. | This analysis includes the twenty participants with available data at one or more study assessment time points at clinic office visit. | Posted | Count of Participants | Participants | From enrollment through 48 weeks |
|
|
|
| 3 |
| 21 |
| 0 |
| 21 |
| 13 |
| 21 |
| Nausea | Gastrointestinal disorders | Systematic Assessment |
|
| Fatigue | General disorders | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Abdominal Pain | Gastrointestinal disorders | Systematic Assessment |
|
| Anorexia | Metabolism and nutrition disorders | Systematic Assessment |
|
| Mouth Sores | Gastrointestinal disorders | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Shortness of Breath | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Weight Loss | Metabolism and nutrition disorders | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | Systematic Assessment |
|
Not provided
Not provided
|
| Week 24 |
|
|
| Week 36 |
|
|
| Week 48 |
|
|
| Distress Score at Week 12 |
|
| Distress Score at Week 24 |
|
| Distress Score at Week 36 |
|
| Distress Score at Week 48 |
|
| No |
|
| Week 13 to 24 |
|
| Week 25 to 32 |
|
| Week 33 to 48 |
|
| No |
|
| Week 13 to 24 |
|
| Week 25 to 32 |
|
| Week 33 to 48 |
|
| No |
|
| Week 13 to 24 |
|
| Week 25 to 32 |
|
| Week 33 to 48 |
|
| No |
|
| Week 13 to 24 |
|
| Week 25 to 32 |
|
| Week 33 to 48 |
|
| No |
|
| Week 13 to 24 |
|
| Week 25 to 32 |
|
| Week 33 to 48 |
|
| No |
|
| Week 13 to 24 |
|
| Week 25 to 32 |
|
| Week 33 to 48 |
|
| No |
|
| Week 13 to 24 |
|
| Week 25 to 32 |
|
| Week 33 to 48 |
|
| No |
|
| Week 13 to 24 |
|
| Week 25 to 32 |
|
| Week 33 to 48 |
|
| No |
|
| Week 13 to 24 |
|
| Week 25 to 32 |
|
| Week 33 to 48 |
|
| No |
|
| Week 13 to 24 |
|
| Week 25 to 32 |
|
| Week 33 to 48 |
|
| Week 1 to 12 |
|
| Week 13 to 24 |
|
| Week 25 to 32 |
|
| Week 33 to 48 |
|
| Week 1 to 12 |
|
| Week 13 to 24 |
|
| Week 25 to 32 |
|
| Week 33 to 48 |
|
| Week 1 to 12 |
|
| Week 13 to 24 |
|
| Week 25 to 32 |
|
| Week 33 to 48 |
|
| Week 1 to 12 |
|
| Week 13 to 24 |
|
| Week 25 to 32 |
|
| Week 33 to 48 |
|
| Week 1 to 12 |
|
| Week 13 to 24 |
|
| Week 25 to 32 |
|
| Week 33 to 48 |
|
| Week 1 to 12 |
|
| Week 13 to 24 |
|
| Week 25 to 32 |
|
| Week 33 to 48 |
|
| Week 1 to 12 |
|
| Week 13 to 24 |
|
| Week 25 to 32 |
|
| Week 33 to 48 |
|
| Week 1 to 12 |
|
| Week 13 to 24 |
|
| Week 25 to 32 |
|
| Week 33 to 48 |
|
| Week 1 to 12 |
|
| Week 13 to 24 |
|
| Week 25 to 32 |
|
| Week 33 to 48 |
|
| Week 1 to 12 |
|
| Week 13 to 24 |
|
| Week 25 to 32 |
|
| Week 33 to 48 |
|