What this study is
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.
What's being tested
- Electronic Health Record Review
Intervention · OTHER
- Internet-Based Intervention
Intervention · OTHER
Receive access to ePRO tool
- Patient Navigation
Intervention · BEHAVIORAL
Receive review of symptoms and referral if needed
- Survey Administration
Intervention · OTHER
Complete ePRO assessments
- Survey Administration
Intervention · OTHER
Both Electronic Health Record Review and Survey Administration
Ancillary studies
Study details
- Official title
- EMPOWER: Enhancing Melanoma Care Through Patient-Reported Outcomes Monitoring With Early, Rapid Immunotherapy Toxicity Subspecialty Care
- Sponsor
- OHSU Knight Cancer Institute
- Conditions
- Melanoma
- Enrolling
- 50 people
- Starts
- 2026-11-01
- Est. completion
- 2029-06-01
- Design
- Open-label, single group
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years and overSex ALLHealthy volunteers AcceptedYou may qualify if
- PATIENT: Age 18 years or older
- PATIENT: Histologically confirmed diagnosis of melanoma
- PATIENT: Plan to begin a standard of care (SOC) immune checkpoint inhibitor (ICI) for the treatment of melanoma per Food and Drug Administration (FDA) approval and/or National Comprehensive Cancer Network (NCCN) guidelines
- PATIENT: Willing and able to provide informed consent
- CAREGIVER: Age 18 years or older
- CAREGIVER: Family member or primary caregiver of a study participant
You can't join if
- 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
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openOHSU Knight Cancer Institute
Portland, Oregon, United States
- Deanne Tibbitts · Contact503-494-4361tibbitts@ohsu.edu
- Deanne Tibbitts · Principal investigator
Study team
Sponsor
OHSU Knight Cancer Institute
Study ID STUDY00029559
Principal investigator
Deanne Tibbitts
OHSU Knight Cancer Institute
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.