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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03867045
Recruitment Status : Suspended (Study deemed non-essential under COVID pandemic,)
First Posted : March 7, 2019
Last Update Posted : May 6, 2020
Sponsor:
Collaborator:
Exelixis
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Metastatic Renal Cell Carcinoma Treated With Cabozantinib Device: Usability of an electronic symptom management application Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 9 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Device Feasibility
Official Title: Development of a Cabozantinib (Cabometyx) Symptom Management Application for Use in Patients With Renal Cancer
Actual Study Start Date : August 21, 2019
Estimated Primary Completion Date : September 2020
Estimated Study Completion Date : September 2020


Arm Intervention/treatment
Experimental: mRCC treated with cabozantinib
Nine patients with mRCC initiating cabozantinib therapy who meet subject eligibility criteria.
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




Primary Outcome Measures :
  1. Number of comments from participants indicating ease of use of the application. [ Time Frame: 12 weeks ]
    Number of comments from participants indicating ease of use of the application.


Secondary Outcome Measures :
  1. 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 ]
    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.

  2. 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 ]
    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.

  3. 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 ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03867045


Locations
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United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27710
Duke Raleigh Hospital
Raleigh, North Carolina, United States, 27609
Sponsors and Collaborators
Duke University
Exelixis
Investigators
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Principal Investigator: Sundhar Ramalingam, MD Duke University
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Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT03867045    
Other Study ID Numbers: Pro00086667
First Posted: March 7, 2019    Key Record Dates
Last Update Posted: May 6, 2020
Last Verified: April 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Carcinoma, Renal Cell
Kidney Neoplasms
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases