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

N/ANot Yet RecruitingNCT07630831

Children's Hospital Los Angeles190 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

190

Conditions

Cancer Childhood

Interventions

Eligibility

Sex: ALLMin age: 20 YearsMax age: 29 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Proportion of participants with Transition to Adult-Focused Survivorship Care

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).

Time frame: Within 18 months following transition "launch" (study enrollment/baseline)

Secondary Outcomes

Change in HRSN score from baseline to each follow-up time point in each study arm.

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)