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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

16 juni 2026 uppdaterad av: Deanne Tibbitts, OHSU Knight Cancer Institute

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.

Studieöversikt

Status

Har inte rekryterat ännu

Betingelser

Intervention / Behandling

Detaljerad beskrivning

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.

Studietyp

Interventionell

Inskrivning (Beräknad)

50

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

  • Förenta staterna
    • Oregon
      • Portland, Oregon, Förenta staterna, 97239
        • OHSU Knight Cancer Institute
        • Kontakt:
        • Huvudutredare:
          • Deanne Tibbitts

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

  • Vuxen
  • Äldre vuxen

Tar emot friska volontärer

Ja

Beskrivning

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

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Stödjande vård
  • Tilldelning: N/A
  • Interventionsmodell: Enskild gruppuppgift
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: 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.
Övrig: Undersökningsadministration
Sidostudier
Övrig: Genomgång av elektroniska journaler
Sidostudier
Övrig: Internet-Based Intervention
Receive access to ePRO tool
Beteende: Patient Navigation
Receive review of symptoms and referral if needed
Andra namn:
  • Patientnavigatorprogram
Övrig: Survey Administration
Complete ePRO assessments

Vad mäter studien?

Primära resultatmått

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

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Proportion of patients who complete data collection at 6 months (retention)
Tidsram: At month 6
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)
Tidsram: From baseline to 6 months
From baseline to 6 months
Proportion of participants rating the study as acceptable (acceptability)
Tidsram: At 6 months
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)
Tidsram: At 6 months
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)
Tidsram: At end of the study, up to 3 years
Assessed via clinician experience measure.
At end of the study, up to 3 years

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

OHSU Knight Cancer Institute

Utredare

  • Huvudutredare: Deanne Tibbitts, OHSU Knight Cancer Institute

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Beräknad)

1 november 2026

Primärt slutförande (Beräknad)

1 juni 2029

Avslutad studie (Beräknad)

1 juni 2029

Studieregistreringsdatum

Först inskickad

11 juni 2026

Först inskickad som uppfyllde QC-kriterierna

16 juni 2026

Första postat (Faktisk)

22 juni 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

22 juni 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

16 juni 2026

Senast verifierad

1 juni 2026

Mer information

Termer relaterade till denna studie

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • STUDY00029559 (Annan identifierare: OHSU Knight Cancer Institute)
  • HT9425261E218 (Annat bidrag/finansieringsnummer: Department of Defense)
  • NCI-2026-03934 (Registeridentifierare: CTRP (Clinical Trial Reporting Program))

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Nej

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

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