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NCT Number: NCT07630831

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

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.

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Key information

Conditions

Cancer Childhood Neoplasms

Age range

20 year–29 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Children's Hospital Los Angeles

Los Angeles, California, 90027, United States

Location contact

David Freyer, DO, MS

CONTACT

David Freyer, DO, MS

PRINCIPAL_INVESTIGATOR

Kimberly Miller, PhD

SUB_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Navigation

Behavioral

Follow Up

Control

Behavioral

Standard of Care

Primary outcomes

  1. 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).

Secondary outcomes

  1. 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)

  2. 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)

  3. 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 )

  4. 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)

  5. 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.

  6. 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.

  7. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

David Freyer, DO, MS

CONTACT

[email protected]

(323) 361-6695

Sponsors and collaborators

Lead sponsor

Children's Hospital Los Angeles

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Important dates

Study start
2026
Primary completion
2029
Study completion
2030
First posted
Jun 5, 2026
Registry last updated
Jun 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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