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

Обзор

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.

Вмешательства

• Поведенческое Navigation
  Follow Up
• Поведенческое Control
  Standard of Care

Первичные конечные точки

• Proportion of participants with Transition to Adult-Focused Survivorship Care [Срок оценки: Within 18 months following transition "launch" (study enrollment/baseline)]

Вторичные конечные точки (7)

• Change in HRSN score from baseline to each follow-up time point in each study arm. [Срок оценки: Baseline to 18 months post-enrollment]
• Change in Global Health-Related Quality of Life Score using Likert scale [Срок оценки: Baseline to 18 months post-enrollment]
• Change in General Self-Efficacy using Likert scale [Срок оценки: 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) [Срок оценки: Baseline to 18 months post-enrollment]
• Change in count for barriers to care as measured by Likert scale barriers to care questionnaire [Срок оценки: Baseline to 18 months post-enrollment]
• Change in Emotional Social Support score using a Likert scale. [Срок оценки: Baseline to 18 months post-enrollment]
• Change in Informational Support score using a Likert scale. [Срок оценки: Baseline to 18 months post-enrollment]

Критерии участия

Критерии включения

• 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.

Критерии исключения

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 1 центр

• Children's Hospital Los Angeles — Los Angeles

Идентификаторы

NCT: NCT07630831 · CHLA-25-00386 · R01CA303651 · NCI-2025-09161

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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