NCT Number: NCT06675643
This study is being done to better understand patient experiences with using a mobile application, known as Vigilant, to monitor symptoms as outpatients and to gather preliminary data on the potential clinical benefit to remote monitoring of adverse events.
Interested in participating?
Request Info18 year and older
All sexes
Observational
Rochester, Minnesota, 55905, United States
Location status: Recruiting
Clinical Trials Referral Office
CONTACT
Lisa A. Kottschade, APRN, CNP
PRINCIPAL_INVESTIGATOR
Renee Bradshaw
CONTACT
Svetomir N. Markovic, MD, PhD
PRINCIPAL_INVESTIGATOR
PRIMARY OBJECTIVES:
I. Optimize the patient (Aim 1) experience of the VIGILANT app workflow. II. Gather preliminary data on the number of patients who develop Grade 3 + 4 immune-related adverse event (irAE) or require ER visit within 100 days of registration and treatment with IPI/NIVO.
OUTLINE: This is an observational study.
Patients undergo standard of care treatment with ipilimumab/nivolumab and answer questions and enter symptoms in the mobile Vigilant application. Patients wearing a compatible watch have their vital signs recorded at the same time symptoms are being entered. Based on the severity of symptoms, patients may be recommended to reach out to their healthcare team or to go to the emergency room. Additionally, patients complete a survey and may have their medical charts reviewed on study.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Non-Interventional study
Time frame: Up to 100 days following treatment with IPI/NIVO
Will be assessed by the number of patients who experience at least one grade 3-4 Immune-Related Adverse Events (IR-AE) within 100 days of treatment with ipilimumab/nivolumab (IPI/NIVO). Events will be self-reported using the VIGILANT app, which is being developed to help manage adverse events after treatment.
Contact information is provided by the study sponsor or research team.
Clinical Trials Referral Office
CONTACT
Renee Bradshaw
CONTACT
Mayo Clinic
Other
Digital Remote Monitoring of Immune Checkpoint Inhibitor Therapy Induced Toxicity: A Feasibility Study of the Vigilant App (Vigilant-2)
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT07213154
Malignant Skin Neoplasm, Neoplasms
Atlanta, Georgia, United States
View Trial DetailsNCT04459273
Adenocarcinoma, Adrenal Gland Diseases
Los Angeles, California, United States
View Trial DetailsNCT02373722
Malignant Skin Neoplasm, Neoplasms
Winston-Salem, North Carolina, United States
View Trial DetailsNCT07042243
Behavior, Behavior, Animal
Gainesville, Florida, United States
View Trial Details