Cancer ChildhoodNCT07630831
Patient Navigation for Improving Transition Success Among Multiply Disadvantaged Young Adult Survivors of Childhood Cancer
A study testing Navigation in people with Cancer Childhood, run by Children's Hospital Los Angeles at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 29 years
- Conditions the study is for
- Cancer Childhood
- What is being tested?
- Navigation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 190 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2026to 1 Sep 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 29 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Show all 10Show fewer
- demonstrate a workable understanding of transition
- have an identified primary care provider
- able to speak and read English or Spanish
- can provide informed consent.
Who cannot join
- do not meet transition criteria
- speak a language other than English or Spanish
- are significantly impaired and cannot provide informed consent.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Children's Hospital Los Angeles
Los Angeles, California, 90027
David Freyer, DO, MS
David Freyer, DO, MS
About this study
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).
Read more
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
- Being tested
- Navigation, Control
- Keywords
- Childhood Cancer, Transition of care, Health-related social needs, Patient Navigation
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NavigationBehavioural
Follow Up
ControlBehavioural
Standard of Care
| Study group | Role | What they receive |
|---|---|---|
| Control | Active comparator | Recontacting patients by a nurse case manager after transition launch to determine transition success. Receives: 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. Receives: Behavioral: Navigation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
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)
Measured: Baseline to 18 months post-enrollment
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)
Measured: Baseline to 18 months post-enrollment
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 )
Measured: 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)
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)
Measured: Baseline to 18 months post-enrollment
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.
Measured: Baseline to 18 months post-enrollment
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.
Measured: Baseline to 18 months post-enrollment
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.
Measured: Baseline to 18 months post-enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2026
- Study start1 Oct 2026 (estimated)
- Primary completion1 Oct 2029 (estimated)
- Study completion1 Sep 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cancer ChildhoodStudies of the same condition, open and under way.
- More trials run by Children's Hospital Los AngelesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 190 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Children's Hospital Los Angeles
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, David Freyer, DO, MS, Children's Hospital Los Angeles
- Investigators
- David Freyer, DO, MS, Principal investigator, Children's Hospital Los AngelesKimberly Miller, PhD, Principal investigator, Children's Hospital Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07630831
- Sponsor's protocol ID
- CHLA-25-00386
- Other IDs
- R01CA303651, NCI-2025-09161
- Status last verified
- Sep 2026
- First submitted
- 2 Jun 2026
- Last updated
- 3 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient Navigation for Improving Transition Success Among Multiply Disadvantaged Young Adult Survivors of Childhood Cancer
- ClinicalTrials.gov ID
- NCT07630831
- Acronym / sponsor ID
- CHLA-25-00386
- Conditions
- Cancer Childhood
- Keywords
- Childhood Cancer, Transition of care, Health-related social needs, Patient Navigation
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 190 participants (estimated)
- Lead sponsor
- Children's Hospital Los AngelesUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- 1 Oct 2029 (estimated)
- Study completion
- 1 Sep 2030 (estimated)
- First posted
- 5 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Active comparator | Behavioral: ControlRecontacting patients by a nurse case manager after transition launch to determine transition success. |
| Navigation | Experimental | Behavioral: NavigationPatients 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. |
Who may qualify
- Ages
- 20 to 29 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (3 listed)
- do not meet transition criteria
- speak a language other than English or Spanish
- are significantly impaired and cannot provide informed consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NavigationFollow Up | Behavioural | Navigation |
| ControlStandard of Care | Behavioural | Control |
Primary outcome
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).
7 secondary outcomes
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 Global Health-Related Quality of Life Score using Likert scale
Time frame: Baseline to 18 months post-enrollment
Change in General Self-Efficacy using Likert scale
Time frame: 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
Change in count for barriers to care as measured by Likert scale barriers to care questionnaire
Time frame: Baseline to 18 months post-enrollment
Change in Emotional Social Support score using a Likert scale.
Time frame: Baseline to 18 months post-enrollment
Change in Informational Support score using a Likert scale.
Time frame: Baseline to 18 months post-enrollment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
David Freyer, DO, MS principal investigator
Children's Hospital Los Angeles
Kimberly Miller, PhD principal investigator
Children's Hospital Los Angeles
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Navigation in people with Cancer Childhood, run by Children's Hospital Los Angeles at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 3 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact David Freyer, DO, MS ((323) 361-6695, DFreyer@chla.usc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of participants with Transition to Adult-Focused Survivorship Care (time frame: Within 18 months following transition "launch" (study enrollment/baseline)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2026; AzTrials last refreshed its copy on 6 Nov 2026.