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Symptom Trajectory Approaches to Research (STAR)

1. september 2026 opdateret af: 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.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Detaljeret 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.

Undersøgelsestype

Observationel

Tilmelding (Anslået)

228

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

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

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Barn
  • Voksen

Tager imod sunde frivillige

Ingen

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
Intervention / Behandling
Children with advanced cancer
Andet: Health surveys
Participants will complete several surveys about their quality of life and health.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
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
Foranstaltningsbeskrivelse
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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

University of Wisconsin, Madison

Samarbejdspartnere

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

Efterforskere

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

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

1. december 2026

Primær færdiggørelse (Anslået)

31. maj 2031

Studieafslutning (Anslået)

31. maj 2031

Datoer for studieregistrering

Først indsendt

1. september 2026

Først indsendt, der opfyldte QC-kriterier

1. september 2026

Først opslået (Faktiske)

4. september 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

4. september 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

1. september 2026

Sidst verificeret

1. august 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

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

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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