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

EMPOWER: Enhancing Melanoma Care Through Patient-Reported Outcomes Monitoring With Early, Rapid Immunotherapy Toxicity Subspecialty Care

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.

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 moderate to severe irAE, weekly for 6 months. If a patient rates a symptom at a frequency or severity level of moderate or higher, a care provider is notified and determines if the symptoms warrant evaluation by a non-oncology subspecialist or can be managed by medical oncology. Patients receive a referral to an appropriate subspecialist, complete an evaluation of the suspected irAE, within 14 days of the referral, and receive standard of care treatment. Patients may optionally have their caregiver enroll to complete an intervention acceptability survey.

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 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