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

NCT07660666 | Not Yet Recruiting

• 3 other identifiers: STUDY00029559HT9425261E218NCI-2026-03934
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Melanoma

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (5)

• Proportion of patients who complete data collection at 6 months (retention)

  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)

  At 6 months

• Proportion of caregivers for enrolled participants rate the study as acceptable (acceptability)

  At 6 months

• Proportion of medical oncologists/subspecialists rate the study as acceptable (acceptability)

  At end of the study, up to 3 years

Study Arms (1)

Supportive care (ePRO monitoring and referrals)

EXPERIMENTAL

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: Electronic Health Record Review; Other: Internet-Based Intervention; Behavioral: Patient Navigation; Other: Survey Administration

Interventions

Electronic Health Record Review OTHER

Ancillary studies

Supportive care (ePRO monitoring and referrals)

Internet-Based Intervention OTHER

Receive access to ePRO tool

Supportive care (ePRO monitoring and referrals)

Patient Navigation BEHAVIORAL

Receive review of symptoms and referral if needed

Also known as: Patient Navigator Program

Supportive care (ePRO monitoring and referrals)

Survey Administration OTHER

Complete ePRO assessments

Supportive care (ePRO monitoring and referrals)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• OHSU Knight Cancer Institute: lead

Study Sites (1)

OHSU Knight Cancer Institute

Portland, Oregon, 97239, United States

Location

MeSH Terms

Conditions

Melanoma

Interventions

Patient Navigation

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Patient-Centered Care; Primary Health Care; Comprehensive Health Care; Patient Care Management; Health Services Administration

Study Officials

• Deanne Tibbitts

  OHSU Knight Cancer Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 11, 2026
• First Posted: June 22, 2026
• Study Start (Estimated): November 1, 2026
• Primary Completion (Estimated): June 1, 2029
• Study Completion (Estimated): June 1, 2029
• Last Updated: June 22, 2026

Record last verified: 2026-06

Locations

US (1)