Software Monitoring of Treatment Related Toxicities in Advanced Renal Cell Carcinoma

November 27, 2023 updated by: Chunkit Fung, University of Rochester

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

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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
Carevive Survey Usage Rates
Time Frame: 48 weeks

Carevive software will track subject compliance with survey logins and whether they access the generated care plans. The percentage of times logged in out of the number of study recommended logins will be tabulated. Also, the percentage of times a careplan was accessed out of the number of times it was offered will be determined.

  • To determine the practicality of the intervention, by analyzing the reasons why subjects fail to self-report treatment-related toxicities or utilize software generated care plans after enrollment.
  • To assess the acceptability of this intervention with validated patient reported usability scores of the software.
  • To determine potential implementation obstacles of the intervention, by assessing the reasons eligible study candidates decline participation.
48 weeks
Reasons Participants Do Not Complete Survey or Utilize Care Plans
Time Frame: 48 weeks
After missing a survey, subjects will be asked the reason at their following login. The reason provided will be sorted into pre-specified categories and presented as a percentage.
48 weeks
Average Usability Score Using the Software Usability Scoring System
Time Frame: 48 weeks
At the 48 week time point or at the point of subject withdrawal from study, they will be asked to take the System Usability Scale. The survey provides us with a score of between 0 and 40 which is then multiplied by 2.5 to convert to a scale of 0 to 100. A SUS score above a 68 would be considered above average and anything below 68 is below average.
48 weeks
Reasons for Declining Study Participation
Time Frame: 48 weeks
If a subject declines to participation in the study, he/she will be asked to provide a reason for declination. If willing, we will have them sign a separate consent with a space to write in their reason. The reason provided will be sorted into pre-specified categories and presented as a percentage.
48 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient Reported Toxicities Using PRO-CTCAE Questions
Time Frame: 48 weeks
Patient reported toxicity data will be collected via Carevive surveys weekly for the first 12 weeks and then every other week for another 36 weeks. We will not deliver the PRO-CTCAE in its entirety but will specifically ask about the following common toxicities that are experienced with oral targeted therapy and immunotherapy: diarrhea, nausea, vomiting, fatigue, hand/foot syndrome, rash, abdominal pain, anorexia, mouth sores, cough and shortness of breath.
48 weeks
Clinician Reported Toxicities Using CTCAE
Time Frame: 48 weeks
Toxicities will also be formally assessed in-office every 3-4 months using CTCAE scoring. The categories chosen are common toxicities that occur with oral targeted therapy and immunotherapy: diarrhea, nausea, vomiting, fatigue, hand/foot syndrome, rash, abdominal pain, appetite, mouth sores, cough and shortness of breath
48 weeks
Quality of Life Determination Using the FKSI-DRS Survey
Time Frame: 48 weeks
Subjects will be asked to fill out the Functional Assessment of Cancer Therapy-Kidney Symptom Index (FKSI-DRS) at baseline and approximately every 3 months in-office.
48 weeks
Distress Level Using the NCCN Distress Thermometer
Time Frame: 48 weeks
The subject will be asked to rate their distress level in-office using the NCCN Distress Thermometer, which is a 1 to 10 numerical scale. This will be delivered during routine office visits approximately every 3 months on a tablet.
48 weeks
• Health Care Utilization Assessment By Quantification of Health Care Visits or Hospitalizations
Time Frame: 48 weeks
Health care utilization will be self-reported by the subject through CareVive software monthly, in addition at the end of the study or at time of withdrawal, a search of the electronic medical record will be performed to determine the number of calls made to oncology care providers and the number of visits to the oncologist during the study period.
48 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Rochester

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 24, 2019

Primary Completion (Estimated)

November 1, 2024

Study Completion (Estimated)

February 1, 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)

November 29, 2023

Last Update Submitted That Met QC Criteria

November 27, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UGUK 17036

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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