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

Official title

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

Overview

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.

Detailed 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 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.

Interventions

• Other Electronic Health Record Review
  Ancillary studies
• Other Internet-Based Intervention
  Receive access to ePRO tool
• Behavioral Patient Navigation
  Receive review of symptoms and referral if needed
• Other Survey Administration
  Complete ePRO assessments
• Other Survey Administration
  Ancillary studies

Primary outcome measures

• Proportion of eligible patients who consent to the study and begin the intervention (feasibility of study enrollment) [Time frame: At enrollment]
• 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) [Time frame: From baseline to 6 months]

Secondary outcome measures (5)

• Proportion of patients who complete data collection at 6 months (retention) [Time frame: At month 6]
• 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) [Time frame: From baseline to 6 months]
• Proportion of participants rating the study as acceptable (acceptability) [Time frame: At 6 months]
• Proportion of caregivers for enrolled participants rate the study as acceptable (acceptability) [Time frame: At 6 months]
• Proportion of medical oncologists/subspecialists rate the study as acceptable (acceptability) [Time frame: At end of the study, up to 3 years]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Supportive care

Study locations

United States · 1 center

• OHSU Knight Cancer Institute — Portland

Identifiers

NCT: NCT07660666 · STUDY00029559 · HT9425261E218 · NCI-2026-03934 · STUDY00029559

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗