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| ID | Type | Description | Link |
|---|---|---|---|
| R01CA303651 | U.S. NIH Grant/Contract | View source | |
| NCI-2025-09161 | Other Identifier | CTRP |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | Active Comparator | Recontacting patients by a nurse case manager after transition launch to determine transition success. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Navigation | Behavioral | Follow Up |
| |
| Control |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| David Freyer, DO, MS | Contact | (323) 361-6695 | DFreyer@chla.usc.edu |
| Name | Affiliation | Role |
|---|---|---|
| David Freyer, DO, MS | Children's Hospital Los Angeles | Principal Investigator |
| Kimberly Miller, PhD | Children's Hospital Los Angeles | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Hospital Los Angeles | Los Angeles | California | 90027 | United States |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
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| Behavioral |
Standard of Care |
|
| 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) | 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 ) | 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) | 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. | 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. | 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. | Baseline to 18 months post-enrollment |