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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 oppdatert 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.

Studieoversikt

Status

Har ikke rekruttert ennå

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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.

Studietype

Intervensjonell

Registrering (Antatt)

50

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Forente stater
    • Oregon
      • Portland, Oregon, Forente stater, 97239
        • OHSU Knight Cancer Institute
        • Ta kontakt med:
        • Hovedetterforsker:
          • Deanne Tibbitts

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Ja

Beskrivelse

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Støttende omsorg
  • Tildeling: N/A
  • Intervensjonsmodell: Enkeltgruppeoppdrag
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 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.
Annen: Undersøkelsesadministrasjon
Hjelpestudier
Annen: Gjennomgang av elektronisk helsejournal
Hjelpestudier
Annen: Internet-Based Intervention
Receive access to ePRO tool
Atferdsmessig: Patient Navigation
Receive review of symptoms and referral if needed
Andre navn:
  • Pasientnavigatorprogram
Annen: Survey Administration
Complete ePRO assessments

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Proportion of eligible patients who consent to the study and begin the intervention (feasibility of study enrollment)
Tidsramme: 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)
Tidsramme: From baseline to 6 months
From baseline to 6 months

Sekundære resultatmål

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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

OHSU Knight Cancer Institute

Etterforskere

  • Hovedetterforsker: Deanne Tibbitts, OHSU Knight Cancer Institute

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

1. november 2026

Primær fullføring (Antatt)

1. juni 2029

Studiet fullført (Antatt)

1. juni 2029

Datoer for studieregistrering

Først innsendt

11. juni 2026

Først innsendt som oppfylte QC-kriteriene

16. juni 2026

Først lagt ut (Faktiske)

22. juni 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

22. juni 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

16. juni 2026

Sist bekreftet

1. juni 2026

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • STUDY00029559 (Annen identifikator: OHSU Knight Cancer Institute)
  • HT9425261E218 (Annet stipend/finansieringsnummer: Department of Defense)
  • NCI-2026-03934 (Registeridentifikator: CTRP (Clinical Trial Reporting Program))

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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