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

June 2, 2026 updated by: David Freyer, DO, MS, Children's Hospital Los Angeles

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 Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

190

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90027
        • Children's Hospital Los Angeles
        • Principal Investigator:
          • David Freyer, DO, MS
        • Contact:
          • David Freyer, DO, MS
        • Sub-Investigator:
          • Kimberly Miller, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Control
Recontacting patients by a nurse case manager after transition launch to determine transition success.
Behavioral: Control
Standard of Care
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.
Behavioral: Navigation
Follow Up

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of participants with Transition to Adult-Focused Survivorship Care
Time Frame: Within 18 months following transition "launch" (study enrollment/baseline)

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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in HRSN score from baseline to each follow-up time point in each study arm.
Time Frame: Baseline to 18 months post-enrollment

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
Change in Global Health-Related Quality of Life Score using Likert scale
Time Frame: Baseline to 18 months post-enrollment

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
Change in General Self-Efficacy using Likert scale
Time Frame: Baseline to 18 months post-enrollment

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
Change in mean scores for Patient-Reported Access to and Experience with Healthcare as measures by CAHPS (Consumer Assessment of Healthcare Providers and Systems)
Time Frame: Baseline to 18 months post-enrollment

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
Change in count for barriers to care as measured by Likert scale barriers to care questionnaire
Time Frame: Baseline to 18 months post-enrollment

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
Change in Emotional Social Support score using a Likert scale.
Time Frame: Baseline to 18 months post-enrollment

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
Change in Informational Support score using a Likert scale.
Time Frame: Baseline to 18 months post-enrollment

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Children's Hospital Los Angeles

Collaborators

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: David Freyer, DO, MS, Children's Hospital Los Angeles
  • Principal Investigator: Kimberly Miller, PhD, Children's Hospital Los Angeles

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

July 1, 2026

Primary Completion (Estimated)

October 1, 2029

Study Completion (Estimated)

September 1, 2030

Study Registration Dates

First Submitted

June 2, 2026

First Submitted That Met QC Criteria

June 2, 2026

First Posted (Actual)

June 5, 2026

Study Record Updates

Last Update Posted (Actual)

June 5, 2026

Last Update Submitted That Met QC Criteria

June 2, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHLA-25-00386
  • R01CA303651 (U.S. NIH Grant/Contract)
  • NCI-2025-09161 (Other Identifier: CTRP)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Cancer Childhood

Clinical Trials on Control

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Pakistan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe