Software Monitoring of Treatment Related Toxicities in Advanced Renal Cell Carcinoma

NCT03229083 | Completed Results DMC

• 2 other identifiers: UGUK 17036UG1CA189961
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Advanced Renal Cell Carcinoma

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (23)

• Functional Assessment of Cancer Therapy-Kidney Symptom Index (FKSI-DRS) Total Score

  From enrollment through 48 weeks

• Distress Level Assessed by NCCN Distress Thermometer

  From enrollment through 48 weeks

• Health Care Utilization Assessment

  From enrollment through 48 weeks

• Participants Reporting Diarrhea

  From enrollment through 48 weeks

• Participants Reporting Nausea

  From enrollment through 48 weeks

Study Arms (1)

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).

Other: Carevive software

Interventions

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.

Use of Carevive software

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Rochester: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

University of Rochester - Wilmot Cancer Institute

Rochester, New York, 14642, United States

Location

Results Point of Contact

• Title: Chunkit Fung
• Organization: University of Rochester

chunkit_fung@urmc.rochester.edu

5852756526

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: July 18, 2017
• First Posted: July 25, 2017
• Study Start: July 24, 2019
• Primary Completion: February 14, 2025
• Study Completion: February 14, 2025
• Last Updated: May 7, 2026
• Results First Posted: May 7, 2026

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)