Software Monitoring of Treatment Related Toxicities in Advanced Renal Cell Carcinoma

Monitoring of Treatment Related Toxicities From Oral Targeted Agents and Immunotherapy Among Patients With Advanced Renal Cell Carcinoma (RCC) Using Carevive Software, a Single-Arm Phase II Feasibility Study

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.

Study Overview

• Status: Completed
• Conditions: Advanced Renal Cell Carcinoma
• Intervention / Treatment: Other: Carevive software

• Study Type: Interventional
• Enrollment (Actual): 21
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • Rochester, New York, United States, 14642
      • University of Rochester - Wilmot Cancer Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Diagnosis of histologically confirmed renal cell carcinoma of any subtype with either pathological or radiographic evidence of metastatic disease
• Greater than 18 years of age
• A participating Wilmot Cancer Center oncologist has determined that candidate should be started on either oral targeted therapy or immunotherapy for treatment of their advanced RCC; this can be for first-line or any subsequent line therapy
• Able to provide written informed consent
• Proficient in the English language and self-reports as literate
• Must have an active email address or access to a smart device on which text messages can be received

Exclusion Criteria:

• Women cannot be breast-feeding
• Does not have regular access to the internet
• Unable to come to the Wilmot Cancer Center for appointments every 3-4 months for routine visits with their primary oncologist
• Subjects who were on the study previously will not be allowed to re-enroll in the event of a treatment change

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Use of Carevive software; Reporting and management of side effects from oral targeted therapy or immunotherapy, through Carevive software, in patients who have advanced Renal Cell Carcinoma (RCC).

Other: Carevive software; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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
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

Collaborators and Investigators

• Sponsor: University of Rochester
• Collaborators: National Cancer Institute (NCI)

Study record dates

Study Major Dates

• Study Start (Actual): July 24, 2019
• Primary Completion (Actual): February 14, 2025
• Study Completion (Actual): February 14, 2025

Study Registration Dates

• First Submitted: July 18, 2017
• First Submitted That Met QC Criteria: July 24, 2017
• First Posted (Actual): July 25, 2017

Study Record Updates

• Last Update Posted (Actual): May 7, 2026
• Last Update Submitted That Met QC Criteria: April 15, 2026
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Male Urogenital Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Neoplasms by Histologic Type; Neoplasms, Glandular and Epithelial; Adenocarcinoma; Urologic Neoplasms; Kidney Neoplasms; Carcinoma; Carcinoma, Renal Cell
• Other Study ID Numbers: UGUK 17036; UG1CA189961 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No