Improving Side Effect Management for Melanoma Patients on Immunotherapy

This study is looking at a new way to help patients with melanoma manage side effects while receiving immune checkpoint inhibitors (a type of immunotherapy that helps your body's immune system fight cancer). These medications can cause immune-related adverse events (irAEs), which are side effects that can affect different parts of your body. The study will test if using an online tool to report your symptoms, combined with quick referrals to specialists, can help manage these side effects better. You can join if you are 18 or older, have melanoma, and are starting an immune checkpoint inhibitor. The study aims to see how many eligible patients join and how often specialists can evaluate side effects within 14 days. The current recruitment status is unclear.

Study design
This interventional study plans to enroll 50 participants. It is not specified if it is randomized or blinded.
What's involved
You would complete weekly online symptom assessments for 6 months. If you report moderate or severe symptoms, a care provider would be notified, and you might be referred to a specialist within 14 days.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for 6 months to assess the feasibility of the intervention delivery.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07660666

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

Not Yet Recruiting
NAAges 18+InterventionalSupportive care
OHSU Knight Cancer Institute
~50 participants
Updated 2026-06-22 on ClinicalTrials.gov
What's tested:Electronic Health Record ReviewInternet-Based InterventionPatient NavigationSurvey Administration

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Proportion of eligible patients who consent to the study and begin the intervention (feasibility of study enrollment)
Measured over At enrollment
+1 more outcome measured
Melanoma
1 sites across 1 states
Oregon1
  • Deanne Tibbitts · PRINCIPAL_INVESTIGATOR · OHSU Knight Cancer Institute

Opens a ready-to-send draft in your own email app — review before sending.

Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime
Eligibility criteria

Inclusion

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

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