Clinical trial NCT03867045: Development of a Cabozantinib (Cabometyx) Symptom Management Application for Use in Patients With Renal Cancer
Official title: Development of a Cabozantinib (Cabometyx) Symptom Management Application for Use in Patients With Renal Cancer
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Metastatic Renal Cell Carcinoma Treated With Cabozantinib
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: Exelixis
First posted: 2019-03-07
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DEVICE_FEASIBILITY

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.

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.

Primary outcomes:
measure: Number of comments from participants indicating ease of use of the application.
timeFrame: 12 weeks
Secondary outcomes:
measure: 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.
timeFrame: 12 weeks
measure: 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.
timeFrame: 12 weeks
measure: 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.
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Raleigh
country: United States
facility: Duke Raleigh Hospital
state: North Carolina
Study officials:
affiliation: Duke University
name: Sundhar Ramalingam, MD
role: PRINCIPAL_INVESTIGATOR
References: