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.

Study Overview

• Status: Not yet recruiting
• Conditions: Melanoma
• Intervention / Treatment: Other: Survey Administration; Other: Electronic Health Record Review; Other: Internet-Based Intervention; Behavioral: Patient Navigation; Other: Survey Administration

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.

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Oregon
    • Portland, Oregon, United States, 97239
      • OHSU Knight Cancer Institute
      • Contact: Deanne Tibbitts; Phone Number: 503-494-4361; Email: tibbitts@ohsu.edu
      • Principal Investigator: Deanne Tibbitts

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Supportive care (ePRO monitoring and referrals); 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.

Other: Survey Administration; Ancillary studies; 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 Names: Patient Navigator Program; Other: Survey Administration; Complete ePRO assessments

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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)		From baseline to 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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)		From baseline to 6 months
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.	At 6 months
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.	At 6 months
Proportion of medical oncologists/subspecialists rate the study as acceptable (acceptability)	Assessed via clinician experience measure.	At end of the study, up to 3 years

Collaborators and Investigators

• Sponsor: OHSU Knight Cancer Institute
• Investigators: Principal Investigator: Deanne Tibbitts, OHSU Knight Cancer Institute

Study record dates

Study Major Dates

• Study Start (Estimated): November 1, 2026
• Primary Completion (Estimated): June 1, 2029
• Study Completion (Estimated): June 1, 2029

Study Registration Dates

• First Submitted: June 11, 2026
• First Submitted That Met QC Criteria: June 16, 2026
• First Posted (Actual): June 22, 2026

Study Record Updates

• Last Update Posted (Actual): June 22, 2026
• Last Update Submitted That Met QC Criteria: June 16, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Neoplasms by Histologic Type; Skin Diseases; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Neuroendocrine Tumors; Nevi and Melanomas; Skin Neoplasms; Skin and Connective Tissue Diseases; Melanoma; Health Services Administration; Patient Care Management; Comprehensive Health Care; Patient-Centered Care; Primary Health Care; Patient Navigation
• Other Study ID Numbers: STUDY00029559 (Other Identifier: OHSU Knight Cancer Institute); HT9425261E218 (Other Grant/Funding Number: Department of Defense); NCI-2026-03934 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No