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Symptom Trajectory Approaches to Research (STAR)

1. september 2026 oppdatert av: University of Wisconsin, Madison

Defining Symptom Trajectories to Inform Risk-Stratified Approaches to Symptom Management in Children With Advanced Cancer

The goal of this observational study is to understand how cancer makes children feel over time. The main things the researchers hope to learn are:

  • When and how often do children have different feelings or sickness;
  • Why do these feelings happen; and,
  • How these feelings change a child's overall health.

Participants will answer simple surveys about their health.

Studieoversikt

Status

Har ikke rekruttert ennå

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

The use of conventional and novel therapeutics to treat children with advanced cancer leads to burdensome physical and psychological symptoms. Advanced cancer is metastatic upon initial diagnosis, relapsed, progressed, or refractory to treatment, resulting in an uncertain and prolonged disease course. Symptom burden and associated suffering are amplified for these children due to disease burden, intense therapy, and often lengthy treatment. Symptom patterns (trajectories) have been identified in children diagnosed with early-stage cancer, but research characterizing symptom patterns over time in the understudied patient population of children with advanced cancer is sparse.

Studietype

Observasjonsmessig

Registrering (Antatt)

228

Kontakter og plasseringer

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

Studiekontakt

Studiesteder

  • Forente stater
    • California
      • Los Angeles, California, Forente stater, 90027
        • Children's Hospital Los Angeles
    • New York
      • New York, New York, Forente stater, 10032
        • New York -Presbyterian Morgan Stanley Children's Hospital
    • Ohio
      • Columbus, Ohio, Forente stater, 43205
        • Nationwide Children's Hospital
    • Oregon
      • Portland, Oregon, Forente stater, 97239
        • OHSU Doernbecher Children's Hospital
    • Wisconsin
      • Madison, Wisconsin, Forente stater, 53705
        • American Family Children's Hospital

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

  • Barn
  • Voksen

Tar imot friske frivillige

Nei

Prøvetakingsmetode

Ikke-sannsynlighetsprøve

Studiepopulasjon

Potential participants will be identified through the pediatric hematology/oncology research team and/or clinicians.

Beskrivelse

Inclusion Criteria - Children:

  • Aged 8-18 years
  • Diagnosis of advanced cancer of any type made by the hematology, oncology, or cellular therapy team
  • Undergoing cancer treatment or comfort care
  • Be English or Spanish literate

Inclusion Criteria - Caregivers:

  • Aged >18
  • Caregiver of a child diagnosed with advanced cancer
  • English or Spanish literate
  • Identified as being substantially involved in caring for the child

Exclusion Criteria:

  • Any condition that would prevent participants from completing surveys

Studieplan

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

Hvordan er studiet utformet?

Designdetaljer

Kohorter og intervensjoner

Gruppe / Kohort
Intervensjon / Behandling
Children with advanced cancer
Annen: Health surveys
Participants will complete several surveys about their quality of life and health.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Change in Pediatric Patient-Reported Outcome Common Terminology Criteria for Adverse Events (Ped-PRO-CTCAE)
Tidsramme: Baseline, bi-weekly for 4 months
Ped-PRO-CTCAE evaluates pediatric cancer symptoms using patient or caregiver reports scored on a 0-to-3 scale across attributes like frequency, severity, and interference. 38 items are scored 0-3, where 0 = never (or equivalent) and 3 = all the time (or equivalent). Scores range from 0 to 114, with higher scores indicating worse symptoms. This score will be used to measure the trajectory of symptoms over time.
Baseline, bi-weekly for 4 months

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Change in PROMIS Pediatric Global Health 7
Tidsramme: Baseline, bi-weekly for 4 months
PROMIS Pediatric Global Health 7 is a 7-item survey used to measure overall physical, mental, and social health in children and adolescents. It is scored using a 5-point Likert scale, where 1 = poor and 5 = excellent. Scores range from 7 to 35, with higher scores indicating better global health.
Baseline, bi-weekly for 4 months
Change in PROMIS Pediatric Mobility - Short Form 7a
Tidsramme: Baseline, bi-weekly for 4 months
PROMIS Pediatric Mobility is a 7-item questionnaire that evaluates self-perceived physical mobility and functioning in children and adolescents. It uses a 5-point Likert scale ranging from "Without no trouble" to "Not able to do". Raw scores range from 7 to 35. Raw scores are translated into normalized T-scores with a US population-level mean of 50 and a standard deviation (SD) of 10. A T-score of 50 represents average mobility for the general population. Scores above 50 mean better-than-average mobility, while scores below 50 indicate greater impairment.
Baseline, bi-weekly for 4 months
Change in PROMIS Pediatric Physical Stress Experiences - Short Form 8a
Tidsramme: Baseline, bi-weekly for 4 months
PROMIS Physical Stress Experiences is an 8-item questionnaire designed to measure physical symptoms of stress in children and adolescents. It is scored by summing the raw item responses (ranging from 8 to 40) and converting that total into a standardized T-score. The raw score maps to a standardized T-score with a mean of 50 and a standard deviation (SD) of 10 for the general population. Higher T-scores reflect a greater level of physical stress.
Baseline, bi-weekly for 4 months

Samarbeidspartnere og etterforskere

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

Sponsor

University of Wisconsin, Madison

Samarbeidspartnere

National Cancer Institute (NCI)
Columbia University
Oregon Health and Science University
Nationwide Children's Hospital
New York Presbyterian Hospital
Children's Hospital Los Angeles
OHSU Doernbecher Children's Hospital

Etterforskere

  • Hovedetterforsker: Kathleen (Kitty) Montgomery, PhD, RN, PCNS-BC, University of Wisconsin, Madison
  • Hovedetterforsker: Kristine Kwekkeboom, PhD, RN, FAAN, University of Wisconsin, Madison
  • Hovedetterforsker: Roger Brown, PhD, University of Wisconsin, Madison

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. desember 2026

Primær fullføring (Antatt)

31. mai 2031

Studiet fullført (Antatt)

31. mai 2031

Datoer for studieregistrering

Først innsendt

1. september 2026

Først innsendt som oppfylte QC-kriteriene

1. september 2026

Først lagt ut (Faktiske)

4. september 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

4. september 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

1. september 2026

Sist bekreftet

1. august 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • 2026-0259
  • UWMSN | Nursing | Administrati (Annen identifikator: UW Madison)
  • 1R01CA307143 (U.S. NIH-stipend/kontrakt)
  • Protocol Version 2/11/26 (Annen identifikator: UW Madison)

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

JA

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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