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Patient Navigation for Improving Transition Success Among Multiply Disadvantaged Young Adult Survivors of Childhood Cancer

1 september 2026 bijgewerkt door: David Freyer, DO, MS, Children's Hospital Los Angeles

The goal of this clinical trial is to improve the successful healthcare transition from pediatric to adult-focused care for childhood cancer survivors. The main questions it aims to answer are

  • Receipt of the intervention (vs. standard of care control) will increase the proportion of CCS achieving transition success to adult-focused survivorship care from 50% to 70%.
  • Receipt of the intervention (vs. standard of care control) will significantly reduce patients' unmet HRSN.
  • Intervention effectiveness will be moderated by sociodemographic factors (gender, race/ethnicity, insurance status), medical risk for late effects, HRSN burden, and patient-reported outcomes (quality of life, self-efficacy).

Researchers will compare those that receive intervention versus standard of care.

Patients are randomized to either an intervention group, receiving structured PN-led sessions and tailored support for care transitions, or a control group receiving standard follow-up by a nurse case manager. High-HRSN patients in the intervention arm get monthly check-ins and coordinated handoffs to adult care providers for continuity.

Studie Overzicht

Toestand

Nog niet aan het werven

Conditie

Interventie / Behandeling

Studietype

Ingrijpend

Inschrijving (Geschat)

190

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

  • Verenigde Staten
    • California
      • Los Angeles, California, Verenigde Staten, 90027
        • Children's Hospital Los Angeles
        • Hoofdonderzoeker:
          • David Freyer, DO, MS
        • Contact:
          • David Freyer, DO, MS
        • Onderonderzoeker:
          • Kimberly Miller, PhD

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

  • Volwassen

Accepteert gezonde vrijwilligers

Nee

Beschrijving

Inclusion Criteria:

  • diagnosed between the ages of 0-19 years with cancer or with any condition treated with cancer-like therapy.
  • currently in follow up at survivorship clinic or had a survivorship launch visit during the 12 months prior to study activation.
  • current age 20-29 (>95% of patients will be age 20-21)
  • meet LIFE Clinic transition readiness criteria, as clinically applied:
  • at least 5 years off treatment
  • medically stable
  • demonstrate a workable understanding of transition
  • have an identified primary care provider
  • able to speak and read English or Spanish
  • can provide informed consent.

Exclusion Criteria:

  • do not meet transition criteria
  • speak a language other than English or Spanish
  • are significantly impaired and cannot provide informed consent.

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
Actieve vergelijker: Control
Recontacting patients by a nurse case manager after transition launch to determine transition success.
Gedragsmatig: Control
Standard of Care
Experimenteel: Navigation
Patients in the intervention have phone or video session with patient navigator at enrollment, 6, 12 and 18 months, or more frequently as dictated by high-risk social needs.
Gedragsmatig: Navigation
Follow Up

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Proportion of participants with Transition to Adult-Focused Survivorship Care
Tijdsspanne: Within 18 months following transition "launch" (study enrollment/baseline)

The proportion of participants who complete a qualifying adult-focused survivorship care visit, defined as:

For higher-risk survivors: a visit to the designated adult survivorship clinic For lower-risk survivors: a visit to a primary care provider that includes discussion of cancer history and/or late effects

Transition success is:

Self-reported by participants and Validated by study staff through contact with the receiving provider

Participants without a cancer-focused component to the visit (e.g., urgent care, vaccination-only visits) will not be considered successful transitions.

The outcome will be analyzed as a binary proportion (success vs. no success).
Within 18 months following transition "launch" (study enrollment/baseline)

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Change in HRSN score from baseline to each follow-up time point in each study arm.
Tijdsspanne: Baseline to 18 months post-enrollment

Change in the number of unmet health-related social needs assessed using the CMS Accountable Health Communities (AHC) HRSN Screening Tool, including domains such as:

Housing instability, Food insecurity, Transportation barriers, Utility assistance needs, and Employment, education, mental health, and disability (supplemental items)

Count 6 (all social needs endorsed) to 0 (no social needs endorsed)
Baseline to 18 months post-enrollment
Change in Global Health-Related Quality of Life Score using Likert scale
Tijdsspanne: Baseline to 18 months post-enrollment

Change in patient-reported quality of life measured using the PROMIS Global Health Scale (10-item instrument), generating:

Physical health summary score Mental health summary score

0 (poor self reported health) -10 (best self reported health)
Baseline to 18 months post-enrollment
Change in General Self-Efficacy using Likert scale
Tijdsspanne: Baseline to 18 months post-enrollment

Change in perceived self-efficacy measured using the PROMIS General Self-Efficacy 10-item scale.

Scores reflect participants' confidence in managing health and behavior and are reported as standardized scores.

1 ( Lowest Confidence ) - 5 ( Highest Confidence )
Baseline to 18 months post-enrollment
Change in mean scores for Patient-Reported Access to and Experience with Healthcare as measures by CAHPS (Consumer Assessment of Healthcare Providers and Systems)
Tijdsspanne: Baseline to 18 months post-enrollment

Patient-reported measures derived from CAHPS (Consumer Assessment of Healthcare Providers and Systems) assessing:

Global rating of healthcare Access barriers Insurance-related difficulties

Outcomes reported as mean scores

Count 0 (Worst Possible Assessment) to 10 (Best Possible Assessment)
Baseline to 18 months post-enrollment
Change in count for barriers to care as measured by Likert scale barriers to care questionnaire
Tijdsspanne: Baseline to 18 months post-enrollment

39-item questionnaire that includes subscales of pragmatics, health knowledge and beliefs, expectations about care, skills, and marginalization.

Likert scale with 0-100 range, where 0 indicates the most barriers and 100 indicates no barriers.
Baseline to 18 months post-enrollment
Change in Emotional Social Support score using a Likert scale.
Tijdsspanne: Baseline to 18 months post-enrollment

Patient-reported social support measured using PROMIS short forms:

Emotional support (4 items each) Likert scale with 0-5 range, where 0 indicates the lowest social support and 5 indicates highest social support.
Baseline to 18 months post-enrollment
Change in Informational Support score using a Likert scale.
Tijdsspanne: Baseline to 18 months post-enrollment

Patient-reported social support measured using PROMIS short forms:

Informational support (4 items each)

Likert scale with 0-5 range, where 0 indicates the lowest social support and 5 indicates highest social support.
Baseline to 18 months post-enrollment

Medewerkers en onderzoekers

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

Sponsor

Children's Hospital Los Angeles

Medewerkers

National Cancer Institute (NCI)

Onderzoekers

  • Hoofdonderzoeker: David Freyer, DO, MS, Children's Hospital Los Angeles
  • Hoofdonderzoeker: Kimberly Miller, PhD, Children's Hospital Los Angeles

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 oktober 2026

Primaire voltooiing (Geschat)

1 oktober 2029

Studie voltooiing (Geschat)

1 september 2030

Studieregistratiedata

Eerst ingediend

2 juni 2026

Eerst ingediend dat voldeed aan de QC-criteria

2 juni 2026

Eerst geplaatst (Werkelijk)

5 juni 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

3 september 2026

Laatste update ingediend die voldeed aan QC-criteria

1 september 2026

Laatst geverifieerd

1 september 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • CHLA-25-00386
  • R01CA303651 (Subsidie/contract van de Amerikaanse NIH)
  • NCI-2025-09161 (Andere identificatie: CTRP)

Plan Individuele Deelnemersgegevens (IPD)

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

NEE

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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