Development of a Cabozantinib (Cabometyx) Symptom Management Application for Use in Patients With Renal Cancer
- Conditions
- Metastatic Renal Cell Carcinoma Treated With Cabozantinib
- Interventions
- Device: Usability of an electronic symptom management application
- Registration Number
- NCT03867045
- Lead Sponsor
- Duke University
- 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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 1
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.
Non-English Speaking. Any patient who is not able to comprehend and operate the technology at the discretion of the enrolling provider.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description mRCC treated with cabozantinib Usability of an electronic symptom management application Nine patients with mRCC initiating cabozantinib therapy who meet subject eligibility criteria.
- Primary Outcome Measures
Name Time Method Number of comments from participants indicating ease of use of the application. 12 weeks Number of comments from participants indicating ease of use of the application.
- Secondary Outcome Measures
Name Time Method 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 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. 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.
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 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.
Trial Locations
- Locations (2)
Duke Raleigh Hospital
🇺🇸Raleigh, North Carolina, United States
Duke University Medical Center
🇺🇸Durham, North Carolina, United States