EMPOWER: Enhancing Melanoma Care Through Patient-Reported Outcomes Monitoring With Early, Rapid Immunotherapy Toxicity Subspecialty Care
OHSU Knight Cancer Institute
Summary
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.
Description
PRIMARY OBJECTIVE: I. Determine the feasibility of an electronic patient reported outcome (ePRO)-based symptom monitoring and subspecialty care referral intervention for identifying and managing irAEs in patients with melanoma. SECONDARY OBJECTIVES: I. Evaluate intervention acceptability for key stakeholders, including patients, caregivers, oncologists, and subspecialists. II. Describe the preliminary efficacy of the intervention to improve management of irAEs. OUTLINE: Patients complete an ePRO assessment, where they rate the frequency and/or severity of symptoms that may indicate a mod…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- Yes
Inclusion Criteria: * 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 Exclusion Criteria: * PATIENT: Previously received ICI therapy * PATIENT: Life expectancy of \< 6 m…
Interventions
- OtherElectronic Health Record Review
Ancillary studies
- OtherInternet-Based Intervention
Receive access to ePRO tool
- BehavioralPatient Navigation
Receive review of symptoms and referral if needed
- OtherSurvey Administration
Complete ePRO assessments
- OtherSurvey Administration
Ancillary studies
Location
- OHSU Knight Cancer InstitutePortland, Oregon