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

Children's Hospital Los Angeles

Status: Begins enrollment this month

Conditions: Cancer Childhood

Treatments: Behavioral: Control; Behavioral: Navigation

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT07630831

NCI-2025-09161 (Other Identifier)

CHLA-25-00386

R01CA303651 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment: 190 estimated patients

Sex: All

Ages: 20 to 29 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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190 participants in 2 patient groups

Control

Active Comparator group

Description:

Recontacting patients by a nurse case manager after transition launch to determine transition success.

Treatment:

Behavioral: Control

Navigation

Experimental group

Description:

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.

Treatment:

Behavioral: Navigation