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

NCT07630831 | Not Yet Recruiting

• 3 other identifiers: CHLA-25-00386R01CA303651NCI-2025-09161
• Study Type: interventional
• Target: 190
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cancer Childhood

Keywords

Childhood Cancer; Transition of care; Health-related social needs; Patient Navigation

Outcome Measures

Primary Outcomes (1)

• 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).

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

Secondary Outcomes (7)

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

  Baseline to 18 months post-enrollment

• Change in Global Health-Related Quality of Life Score using Likert scale

  Baseline to 18 months post-enrollment

• Change in General Self-Efficacy using Likert scale

  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)

  Baseline to 18 months post-enrollment

• Change in count for barriers to care as measured by Likert scale barriers to care questionnaire

  Baseline to 18 months post-enrollment

Study Arms (2)

Control

ACTIVE COMPARATOR

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

Behavioral: Control

Navigation

EXPERIMENTAL

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.

Behavioral: Navigation

Interventions

Navigation BEHAVIORAL

Follow Up

Navigation

Control BEHAVIORAL

Standard of Care

Control

Eligibility Criteria

• Age: 20 Years - 29 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• National Cancer Institute (NCI): collaborator
• Children's Hospital Los Angeles: lead

Study Sites (1)

Children's Hospital Los Angeles

Los Angeles, California, 90027, United States

Location

MeSH Terms

Conditions

Neoplasms

Study Officials

• David Freyer, DO, MS

  Children's Hospital Los Angeles

  PRINCIPAL INVESTIGATOR

• Kimberly Miller, PhD

  Children's Hospital Los Angeles

  PRINCIPAL INVESTIGATOR

Central Study Contacts

David Freyer, DO, MS

CONTACT

(323) 361-6695; DFreyer@chla.usc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Staff/USC Faculty CWR

Study Record Dates

• First Submitted: June 2, 2026
• First Posted: June 5, 2026
• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): October 1, 2029
• Study Completion (Estimated): September 1, 2030
• Last Updated: June 5, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)