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.
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
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)
Single group
Electronic Health Record Review
Other interventionAncillary studies
Internet-Based Intervention
Other interventionReceive access to ePRO tool
Patient Navigation
BehavioralReceive review of symptoms and referral if needed
Survey Administration
Other interventionComplete ePRO assessments
Survey Administration
Other interventionAncillary studies
Proportion of eligible patients who consent to the study and begin the intervention (feasibility of study enrollment)
Will estimate the proportion of patients enrolled with 95% confidence intervals.
Proportion of patients evaluated by subspecialists in ≤ 14 days among participants who enrolled and developed a suspected immune related adverse events (irAE) (grade 2 or higher) (feasibility of intervention delivery)
Proportion of patients who complete data collection at 6 months (retention)
Will estimate the proportion of patients retained in the study and adherent to electronic patient reported outcomes with 95% confidence intervals.
Proportion of weeks a Patient Reported Outcome-Common Terminology Criteria for Adverse Events questionnaire was completed out of the number of weeks since starting the intervention (ePRO adherence)
Proportion of participants rating the study as acceptable (acceptability)
Assessed via adapted from Basch et al's survey. Acceptability is defined as a mean summary score of 3 or higher.
Proportion of caregivers for enrolled participants rate the study as acceptable (acceptability)
Assessed via adapted from Basch et al's survey. Acceptability is defined as a mean summary score of 3 or higher.
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