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CCS Transitions to Adult Care

6 november 2026 uppdaterad av: 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).

Studieöversikt

Studietyp

Interventionell

Inskrivning (Beräknad)

100

Fas

  • Inte tillämpbar

Kontakter och platser

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

Studiekontakt

Studieorter

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

18 år och äldre (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

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

Studieplan

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

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: 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.

Inget ingripande: 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

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Proportion of participants with who attend an adult onco-primary care visit
Tidsram: 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

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Proportion of participants with who schedule an adult onco-primary care visit
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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

Samarbetspartners och utredare

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

Utredare

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

Publikationer och användbara länkar

Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.

Allmänna publikationer

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 april 2027

Primärt slutförande (Beräknad)

31 augusti 2030

Avslutad studie (Beräknad)

31 augusti 2030

Studieregistreringsdatum

Först inskickad

6 november 2026

Först inskickad som uppfyllde QC-kriterierna

6 november 2026

Första postat (Faktisk)

12 november 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

12 november 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

6 november 2026

Senast verifierad

1 oktober 2026

Mer information

Termer relaterade till denna studie

Andra studie-ID-nummer

  • STU20261556
  • R01CA303339 (U.S.S. NIH-anslag/kontrakt)

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