ClinicalTrials.gg
Not yet recruitingNCT07630831Updated Sep 3, 2026

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

An interventional study of Navigation and Control in Cancer Childhood, sponsored by Children's Hospital Los Angeles. Not yet recruiting at 1 site in United States. Open to participants aged 20 Years to 29 Years. Per ClinicalTrials.gov, last updated 2026-09-03.

Sponsored by Children's Hospital Los Angeles · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
190
Allocation
Randomized
Ages
20 Years to 29 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Cancer Childhood

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Keywords

  • Childhood Cancer
  • Transition of care
  • Health-related social needs
  • Patient Navigation
03

In context

Neoplasms

10,818 studies on the registry are indexed under Neoplasms; 2,324 are open to participants now.

This study's planned enrollment of 190 is above the median of 60 across 7,703 interventional studies indexed under Neoplasms.

Browse Neoplasms studies →

Lead sponsor

Children's Hospital Los Angeles is the lead sponsor of 152 studies on the registry; 46 are open to participants now.

Of its 9 completed or terminated interventional studies of FDA-regulated products, 6 (67%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 29 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 .

Exclusion criteria

Exclusion Criteria:

  • do not meet transition criteria
  • speak a language other than English or Spanish
  • are significantly impaired and cannot provide .
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
190 participants (estimated)

Study arms

  • Active comparator
    Control

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

    Behavioral: Control

  • 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

Interventions

  • BehavioralNavigation

    Follow Up

  • BehavioralControl

    Standard of Care

06

What researchers measure

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).

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

Secondary outcomes

  1. 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)

    Time frame: Baseline to 18 months post-enrollment

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

    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)

    Time frame: Baseline to 18 months post-enrollment

  3. Change in General Self-Efficacy using Likert scale

    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 )

    Time frame: Baseline to 18 months post-enrollment

  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)

    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)

    Time frame: Baseline to 18 months post-enrollment

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

    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.

    Time frame: Baseline to 18 months post-enrollment

  6. Change in Emotional Social Support score using a Likert scale.

    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.

    Time frame: Baseline to 18 months post-enrollment

  7. Change in Informational Support score using a Likert scale.

    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.

    Time frame: Baseline to 18 months post-enrollment

07

Study locations

1 site
  • Children's Hospital Los Angeles
    Los Angeles, California 90027, United States
    • David Freyer, DO, MS · Contact
    • David Freyer, DO, MS · Principal investigator
    • Kimberly Miller, PhD · Sub investigator
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Oct 2026; primary completion for Oct 2029, 36 months later.

Of 1,981 non-industry interventional studies with no phase under Neoplasms, half reached primary completion within 29 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 52. This study's planned 36 months is above that.

Counting every sponsor, half of 2,056 studies reached it within 29 months; a quarter within 13 and three quarters within 52.

Neoplasms covers many different conditions, not one, so the studies compared here vary widely. Read these figures as a rough guide.

How these figures are worked out, and which studies are left out of them.

Registered
Jun 2, 2026
First posted
Jun 5, 2026
StartEst.
Oct 1, 2026
Primary completionEst.
Oct 1, 2029
CompletionEst.
Sep 1, 2030
Last update
Sep 3, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 3, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07630831
Responsible party
David Freyer, DO, MS (Medical Staff/USC Faculty CWR, Children's Hospital Los Angeles) — Principal investigator
First posted
Jun 5, 2026
Start date
Oct 1, 2026 (estimated)
Primary completion
Oct 1, 2029 (estimated)
Completion
Sep 1, 2030 (estimated)
Last update
Sep 3, 2026

Study contacts

David Freyer, DO, MS
Contact
DFreyer@chla.usc.edu
(323) 361-6695
David Freyer, DO, MS
principal investigator · Children's Hospital Los Angeles
Kimberly Miller, PhD
principal investigator · Children's Hospital Los Angeles

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.

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