Feasibility of an Enhanced Symptom Monitoring and Expedited Subspecialty Care Referral Intervention to Improve Side Effect Management for Patients With Melanoma Receiving an Immune Checkpoint Inhibitor (NCT07660666)
EMPOWER: Enhancing Melanoma Care Through Patient-Reported Outcomes Monitoring With Early, Rapid Immunotherapy Toxicity Subspecialty Care
🩺 Plain-English Summary (8th-Grade Level)
This clinical trial tests the feasibility of patient reported outcomes monitoring with early, rapid immunotherapy toxicity subspecialty care to improve side effect management for patients with melanoma receiving an immune checkpoint inhibitor. Immune checkpoint inhibitors have improved outcomes for patients with advanced melanoma, but their use is frequently complicated by immune related adverse events (irAEs). IrAEs can affect any organ system, range in severity from mild to life threatening, and often require a pause or stopping of immunotherapy treatment. Early identification and management of irAEs may reduce progression to severe toxicity. Electronic patient self reporting of symptoms with ways to support early involvement of non oncology subspecialists may be a feasible way to improve side effect management for patients with melanoma receiving an immune checkpoint inhibitor.
Who can join: To join this study, participants generally need to meet the listed inclusion criteria (6 items) and avoid the listed exclusions (9 items).
Location: OHSU Knight Cancer Institute — Portland, Oregon
Age range: 18 Years
🧪 Interventions in This Study
- Electronic Health Record Review (OTHER)
- Internet-Based Intervention (OTHER)
- Patient Navigation (BEHAVIORAL)
- Survey Administration (OTHER)
- Survey Administration (OTHER)
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- Exclusion Criteria:
- PATIENT: Previously received ICI therapy
- PATIENT: Life expectancy of \< 6 months at time of enrollment
- PATIENT: Concurrently receiving a non-ICI systemic therapy
- PATIENT: Concurrently receiving radiation, unless hypofractionated palliative radiation prescribed to alleviate poorly controlled symptoms (e.g., pain)
- PATIENT: Needs to rely on a proxy to complete patient-reported outcome instruments
- PATIENT: Unwilling or unable to complete surveys electronically
- CAREGIVER: Needs to rely on a proxy to complete survey instrument(s)
- CAREGIVER: Unwilling or unable to complete surveys electronically
🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
📍 All Participating Trial Locations (1 Sites)
- OHSU Knight Cancer Institute — Portland, Oregon
📞 Contact the Study Coordinator
Phone: (503) 494-4361
Email: tibbitts@ohsu.edu
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Melanoma
- Phase I/IIa Dose Finding Study of Triplet Regimen of Relatlimab Ipilimumab and NIvolumab in First Line Therapy of Metastatic Melanoma (TRINITY) — Houston, Texas
- Storage and Research Use of Human Bio-specimens From Melanoma Patients and Clinical Testing for Assignment of Treatment — Nashville, Tennessee
- Randomized Study Comparing Two Dosing Schedules for Hypofractionated Image-Guided Radiation Therapy — San Francisco, California
- A Study to Assess the Long-term Safety Outcomes in Patients Previously Treated With RP1, RP2, or RP3 — La Jolla, California
- In Vivo Real-time Detection of Circulating Melanoma Cells — Little Rock, Arkansas
Explore by condition: All Melanoma clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.