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

Part of paid clinical trials in Portland, Oregon.

Sponsor
OHSU Knight Cancer Institute
Study ID
NCT07660666
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Nov 1, 2026
Status verified
Jun 2026
Primary completion
Jun 1, 2029
Completion
Jun 1, 2029

Study Design

Enrollment
50 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE

Arms

  • 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.

Primary Outcome Measure

Proportion of eligible patients who consent to the study and begin the intervention (feasibility of study enrollment) [ Time Frame: At enrollment ]

Locations (1)

FacilityCityStateZIPSite coordinators
OHSU Knight Cancer InstitutePortlandOregon97239
Deanne Tibbitts
[email protected]
503-494-4361
Deanne Tibbitts (PRINCIPAL_INVESTIGATOR)

Find similar trials in Portland, OR

By condition
Melanoma
By specialty
OncologySkin cancerDermatology
By research site
OHSU Knight Cancer Institute· Portland, OR

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