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

Metastatic Renal Cell Carcinoma Treated With Cabozantinib Clinical Trial

— Cabo App  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03867045
• Other study ID #: Pro00086667
• Status: Terminated
• Phase: N/A
• Start date: August 21, 2019
• Est. completion date: December 16, 2019

Study information

• Verified date: November 2020
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1
• Est. completion date: December 16, 2019
• Est. primary completion date: December 16, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma, Renal Cell
• Kidney Neoplasms
• Metastatic Renal Cell Carcinoma Treated With Cabozantinib

Intervention

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

Locations

Country	Name	City	State
United States	Duke University Medical Center	Durham	North Carolina
United States	Duke Raleigh Hospital	Raleigh	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Duke University	Exelixis

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of comments from participants indicating ease of use of the application.	Number of comments from participants indicating ease of use of the application.	12 weeks
Secondary	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.	12 weeks
Secondary	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.	12 weeks
Secondary	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.	12 weeks