Development of a Cabozantinib (Cabometyx) Symptom Management Application for Use in Patients With Renal Cancer (Cabo App)

June 10, 2021 updated by: Duke University
The purpose of this study is to develop an on-line electronic symptom management application that can ultimately be used to improve clinical outcomes in patients with mRCC treated with cabozantinib.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

This is a single-site, prospective technology-based, clinical trial. Nine patients with mRCC initiating cabozantinib therapy who meet subject eligibility criteria will be enrolled in this study. Subjects will be given an iPOD touch with the symptom monitoring application installed, physical activity and blood pressure monitors. Each patient will be kept on study for the first 12 weeks of therapy with cabozantinib. Subjects on treatment for less than 12 weeks will not be replaced.The symptoms and other data (physical activity, blood pressure) recorded electronically by the patient will be compared to symptoms recorded in the medical record at interval clinic visits.

Study Type

Interventional

Enrollment (Actual)

1

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

  • United States
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Duke University Medical Center
      • Raleigh, North Carolina, United States, 27609
        • Duke Raleigh Hospital

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

Genders Eligible for Study

All

Description

Inclusion Criteria:

Patients > 18 years of age Patients planning to start treatment with cabozantinib therapy for renal cancer.

Technology requirement: The patient will need to have home wireless internet access for use of the software and technology in this study. The patient will need to already have or be willing to set up a Duke MyChart account.

Exclusion Criteria:

Non-English Speaking. Any patient who is not able to comprehend and operate the technology at the discretion of the enrolling provider.

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: Device Feasibility
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: mRCC treated with cabozantinib
Nine patients with mRCC initiating cabozantinib therapy who meet subject eligibility criteria.
Device: Usability of an electronic symptom management application
Usability of an electronic symptom management application in a pilot group of patients receiving cabozantinib for mRCC through data analytics and feedback from users

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of comments from participants indicating ease of use of the application.
Time Frame: 12 weeks
Number of comments from participants indicating ease of use of the application.
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Blood pressure (BP) readings measured daily by the BP monitoring device compared with those BP readings measured at interval clinic visits within the first 12 weeks to determine similar detection of symptoms.
Time Frame: 12 weeks
Blood pressure (BP) readings measured daily by the BP monitoring device compared with those BP readings measured at interval clinic visits within the first 12 weeks to determine similar detection of symptoms.
12 weeks
Movement recorded daily by the activity tracking device compared with ECOG assessment outcomes measured during interval clinic visits within the first 12 weeks to determine similar estimates of activity.
Time Frame: 12 weeks
Movement recorded daily by the activity tracking device compared with ECOG assessment outcomes measured during interval clinic visits within the first 12 weeks to determine similar estimates of activity.
12 weeks
Number and frequency of adverse symptoms reported in the symptom management application compared with clinical assessment of adverse events recorded at interval clinic visits within the first 12 weeks to determine similar report of adverse symptoms.
Time Frame: 12 weeks
Number and frequency of adverse symptoms reported in the symptom management application compared with clinical assessment of adverse events recorded at interval clinic visits within the first 12 weeks to determine similar report of adverse symptoms.
12 weeks

Collaborators and Investigators

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

Sponsor

Duke University

Collaborators

Exelixis

Investigators

  • Principal Investigator: Sundhar Ramalingam, MD, Duke University

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)

August 21, 2019

Primary Completion (Actual)

December 16, 2019

Study Completion (Actual)

December 16, 2019

Study Registration Dates

First Submitted

February 15, 2019

First Submitted That Met QC Criteria

March 6, 2019

First Posted (Actual)

March 7, 2019

Study Record Updates

Last Update Posted (Actual)

June 14, 2021

Last Update Submitted That Met QC Criteria

June 10, 2021

Last Verified

November 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pro00086667

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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