Using a mobile app to monitor side effects of melanoma treatment
Digital Remote Monitoring of Immune Checkpoint Inhibitor Therapy Induced Toxicity: A Feasibility Study of the Vigilant App (Vigilant-2)
This study is testing a mobile app that helps people with melanoma track their symptoms while receiving treatment to see how well it works in managing side effects.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Mayo Clinic Academic / other |
| Drugs / interventions | ipilimumab, nivolumab |
| Locations | 1 site (Rochester, Minnesota) |
| Trial ID | NCT06675643 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the patient experience with the Vigilant mobile application, which is designed to monitor symptoms in patients undergoing treatment with ipilimumab and nivolumab for melanoma. Patients will report their symptoms and vital signs through the app, allowing healthcare providers to assess the severity of adverse events and recommend appropriate actions. The study will also collect preliminary data on the incidence of severe immune-related adverse events and emergency room visits within 100 days of treatment initiation.
Who should consider this trial
Good fit: Ideal candidates include patients with malignant skin neoplasms, specifically those starting dual immune checkpoint inhibitor therapy with ipilimumab and nivolumab.
Not a fit: Patients who are not starting treatment with ipilimumab and nivolumab or those who do not have melanoma may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could enhance patient safety and improve management of treatment-related side effects for melanoma patients.
How similar studies have performed: Other studies have shown promise in using mobile applications for remote monitoring of patient symptoms, indicating potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Any skin cancer/melanoma patient starting dual \[ipilimumab/nivolumab (IPI/NIVO)\] immune checkpoint inhibitor (ICI) therapy Exclusion Criteria: * Does not meet inclusion criteria
Where this trial is running
Rochester, Minnesota
- Mayo Clinic in Rochester — Rochester, Minnesota, United States (Recruiting)
Study contacts
- Principal investigator: Svetomir N. Markovic, MD, PhD — Mayo Clinic
- Study coordinator: Clinical Trials Referral Office
- Email: mayocliniccancerstudies@mayo.edu
- Phone: 855-776-0015
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.