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CCS Transitions to Adult Care

6 november 2026 bijgewerkt door: Rebecca Eary, University of Texas Southwestern Medical Center

Novel Linkages and Navigation to Improve Childhood and Adolescent Cancer Survivors' Care Transitions: A Pilot Randomized Controlled Trial Across Three Health Care Systems

In response to RFA-CA-24-027: Addressing Barriers to Healthcare Transitions for Survivors of Childhood and Adolescent Cancers, this study targets barriers at multiple levels and stages in care transition. The study will use a pilot randomized controlled trial testing an interventiont to improve transitions to adult survivorship care among active childhood cancer survivors (CCS) who are newly adults.

Aim: Develop and test a multilevel intervention to improve rates of follow-up visit completion among CCS transitioning from pediatric survivorship care to one of three adult onco-primary care clinics.

Hypothesis: Adult CCS receiving nurse navigation, education, and electronic referral will be more likely to complete follow-up visits at an adult onco-primary care clinic than those on standard referral pathways (electronic referral only).

Studie Overzicht

Studietype

Ingrijpend

Inschrijving (Geschat)

100

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Locaties

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar en ouder (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

Inclusion Criteria:

  • Are scheduled for a final pediatric survivorship visit after the study's enrollment start (target: March 2027) but within 1 month of eligibility assessment date,
  • Completed cancer treatment >30 months prior to eligibility assessment date,
  • Are at least 18 years old at eligibility assessment date, and
  • Are able to independently understand, and willing to sign, a written informed consent document.

Exclusion Criteria:

  • Were treated for non-cancer diagnoses (e.g., received chemotherapy or radiation for another non-cancer condition, e.g., aplastic anemia), or
  • Do not want to attend onco-primary care at UTSW (i.e., have a different planned clinician or clinic for survivorship care).
  • Speak or write a language other than English or Spanish

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: Enhanced Referral Pathway (ERP)

Participants randomized to the ERP arm will receive the SRP, tailored patient education, and patient navigation mapped to the four components of patient navigation

A nurse navigator trained in patient navigation and motivational interviewing will contact CCS (childhood cancer survivor) randomized to the ERP arm and provide a brief introduction to the importance of survivorship care and schedule the patient for an appointment at an adult onco-primary care clinic. The nurse navigator will also schedule at an initial one-hour telehealth visit with the CCS for ~1 month after their last Pediatric ACE visit. During the initial telehealth visit, the navigator will provide tailored patient education and individualized navigation based on the baseline survey results for each adult CCS. The navigator will assess additional educational needs or barriers to determine whether additional visits are needed. Every CCS in the ERP arm will have at least one telehealth visit, but may have as many as five, as needed.

Geen tussenkomst: Standard Referral Pathway (SRP)

For the SRP, clinicians will send an electronic Care Everywhere referral to the adult onco-primary care program, via the ACE coordinator, an existing clinical staff member in onco-primary care. The coordinator will attempt to contact the adult participant 3 times by telephone or MyChart, which includes text messages. Once contact is made, the ACE coordinator will assess current insurance status and schedule a visit in one of the three onco-primary care clinics depending on patient preference, location, and insurance type

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Proportion of participants with who attend an adult onco-primary care visit
Tijdsspanne: Within 24 months after study enrollment

The proportion of participants in each arm who attend an onco-primary care visit.

Visit attendance will be assessed through clinic scheduling data.

The outcome will be analyzed as a binary proportion (attended vs. did not attend)

Within 24 months after study enrollment

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Proportion of participants with who schedule an adult onco-primary care visit
Tijdsspanne: Within 24 months after study enrollment

The proportion of participants in each arm who schedule an onco-primary care visit.

Visit scheduling will be assessed through clinic scheduling data.

The outcome will be analyzed as a binary proportion (scheduled vs. did not schedule)

Within 24 months after study enrollment
Change in transition readiness
Tijdsspanne: Assessed at baseline, after navigation appointment, and annually until study end

Change in score on the the Transition Readiness Assessment for Youth scale.

The scale includes twenty readiness items rated as No (0), I want to learn (1), or Yes (2).

The items will be summed and the outcome will be analyzed as a scale variable ranging from 0 (lowest readiness) to 40 (highest readiness)

Assessed at baseline, after navigation appointment, and annually until study end
Change in health care self-efficacy
Tijdsspanne: Assessed at baseline, after navigation appointment, and annually until study end

Assessed via the Healthcare Self-Efficacy Scale (3-item instrument).

The items are rated on a 3-point Likert-type scale: (1) not confident, (2) confident, (3) very confident.

The items will be averaged and the outcome will be anaylzed as scale variable ranging from 1 (least confident) to 3 (most confident).

Assessed at baseline, after navigation appointment, and annually until study end
Proportion of participants with who attended a primary care visit
Tijdsspanne: Assessed at baseline, after navigation appointment, and annually until study end

The proportion of participants who complete a qualifying primary care visit, defined as: a visit with any primary care or a visit to an onco-primary care clinic.

Self-reported by participants and assessed through onco-primary care clinic scheduling data.

The outcome will be analyzed as a binary proportion (attended primary care vs. did not attend primary care).

Assessed at baseline, after navigation appointment, and annually until study end

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Onderzoekers

  • Hoofdonderzoeker: Rebecca Eary, DO, MPH, University of Texas Southwestern Medical Center
  • Hoofdonderzoeker: Amy E Hughes, PhD, MPH, University of Texas Southwestern Medical Center
  • Hoofdonderzoeker: L. Aubree Shay, PhD, MSSW, The University of Texas Health Science Center, Houston

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Algemene publicaties

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Geschat)

1 april 2027

Primaire voltooiing (Geschat)

31 augustus 2030

Studie voltooiing (Geschat)

31 augustus 2030

Studieregistratiedata

Eerst ingediend

6 november 2026

Eerst ingediend dat voldeed aan de QC-criteria

6 november 2026

Eerst geplaatst (Werkelijk)

12 november 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

12 november 2026

Laatste update ingediend die voldeed aan QC-criteria

6 november 2026

Laatst geverifieerd

1 oktober 2026

Meer informatie

Termen gerelateerd aan deze studie

Andere studie-ID-nummers

  • STU20261556
  • R01CA303339 (Subsidie/contract van de Amerikaanse NIH)

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

ONBESLIST

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

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