Patient Navigation for Improving Transition Success Among Multiply Disadvantaged Young Adult Survivors of Childhood Cancer
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.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: David Freyer, DO, MS
- Número de teléfono: (323) 361-6695
- Correo electrónico: DFreyer@chla.usc.edu
Ubicaciones de estudio
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California
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Los Angeles, California, Estados Unidos, 90027
- Children's Hospital Los Angeles
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Investigador principal:
- David Freyer, DO, MS
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Contacto:
- David Freyer, DO, MS
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Sub-Investigador:
- Kimberly Miller, PhD
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
Acepta Voluntarios Saludables
Descripción
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.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Comparador activo: Control
Recontacting patients by a nurse case manager after transition launch to determine transition success.
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Standard of Care
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Experimental: 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.
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Follow Up
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Proportion of participants with Transition to Adult-Focused Survivorship Care
Periodo de tiempo: Within 18 months following transition "launch" (study enrollment/baseline)
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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)
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Change in HRSN score from baseline to each follow-up time point in each study arm.
Periodo de tiempo: Baseline to 18 months post-enrollment
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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
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Change in Global Health-Related Quality of Life Score using Likert scale
Periodo de tiempo: Baseline to 18 months post-enrollment
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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
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Change in General Self-Efficacy using Likert scale
Periodo de tiempo: Baseline to 18 months post-enrollment
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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
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Change in mean scores for Patient-Reported Access to and Experience with Healthcare as measures by CAHPS (Consumer Assessment of Healthcare Providers and Systems)
Periodo de tiempo: Baseline to 18 months post-enrollment
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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
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Change in count for barriers to care as measured by Likert scale barriers to care questionnaire
Periodo de tiempo: Baseline to 18 months post-enrollment
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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
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Change in Emotional Social Support score using a Likert scale.
Periodo de tiempo: Baseline to 18 months post-enrollment
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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
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Change in Informational Support score using a Likert scale.
Periodo de tiempo: Baseline to 18 months post-enrollment
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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
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: David Freyer, DO, MS, Children's Hospital Los Angeles
- Investigador principal: Kimberly Miller, PhD, Children's Hospital Los Angeles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- CHLA-25-00386
- R01CA303651 (Subvención/contrato del NIH de EE. UU.)
- NCI-2025-09161 (Otro identificador: CTRP)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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