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

Primary Purpose

Metastatic Renal Cell Carcinoma Treated With Cabozantinib

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Usability of an electronic symptom management application
Sponsored by
Duke University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional device feasibility trial for Metastatic Renal Cell Carcinoma Treated With Cabozantinib

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Duke University Medical Center
  • Duke Raleigh Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

mRCC treated with cabozantinib

Arm Description

Nine patients with mRCC initiating cabozantinib therapy who meet subject eligibility criteria.

Outcomes

Primary Outcome Measures

Number of comments from participants indicating ease of use of the application.
Number of comments from participants indicating ease of use of the application.

Secondary Outcome Measures

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.
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.
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.
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.
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.
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.

Full Information

First Posted
February 15, 2019
Last Updated
June 10, 2021
Sponsor
Duke University
Collaborators
Exelixis
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1. Study Identification

Unique Protocol Identification Number
NCT03867045
Brief Title
Development of a Cabozantinib (Cabometyx) Symptom Management Application for Use in Patients With Renal Cancer
Acronym
Cabo App
Official Title
Development of a Cabozantinib (Cabometyx) Symptom Management Application for Use in Patients With Renal Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Terminated
Why Stopped
Study deemed non-essential under COVID pandemic,
Study Start Date
August 21, 2019 (Actual)
Primary Completion Date
December 16, 2019 (Actual)
Study Completion Date
December 16, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Duke University
Collaborators
Exelixis

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastatic Renal Cell Carcinoma Treated With Cabozantinib

7. Study Design

Primary Purpose
Device Feasibility
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
1 (Actual)

8. Arms, Groups, and Interventions

Arm Title
mRCC treated with cabozantinib
Arm Type
Experimental
Arm Description
Nine patients with mRCC initiating cabozantinib therapy who meet subject eligibility criteria.
Intervention Type
Device
Intervention Name(s)
Usability of an electronic symptom management application
Intervention Description
Usability of an electronic symptom management application in a pilot group of patients receiving cabozantinib for mRCC through data analytics and feedback from users
Primary Outcome Measure Information:
Title
Number of comments from participants indicating ease of use of the application.
Description
Number of comments from participants indicating ease of use of the application.
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
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.
Description
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
Title
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.
Description
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
Title
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.
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sundhar Ramalingam, MD
Organizational Affiliation
Duke University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Duke Raleigh Hospital
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27609
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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