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.
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
Allocation
NA
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Enrollment
1
Usability of an electronic symptom management application in a pilot group of patients receiving cabozantinib for mRCC through data analytics and feedback from users
Duke University Medical Center
Durham, North Carolina, United States
Duke Raleigh Hospital
Raleigh, North Carolina, United States
Number of comments from participants indicating ease of use of the application.
Number of comments from participants indicating ease of use of the application.
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.
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
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.
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.
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
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