ClinicalTrials.gg
Not yet recruitingNCT07934329Updated Nov 12, 2026

CCS Transitions to Adult Care

An interventional study of Nurse navigation and patient education in Childhood Cancer Survivors, Adolescent and Young Adult Cancer Survivors and Primary Care, sponsored by University of Texas Southwestern Medical Center. Not yet recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-12.

Sponsored by University of Texas Southwestern Medical Center · Not applicable, Interventional, and Treatment

Updated Nov 12, 2026Newly registeredGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

In response to RFA-CA-24-027: Addressing Barriers to Healthcare Transitions for Survivors of Childhood and Adolescent Cancers, this study targets barriers at multiple levels and stages in care transition. The study will use a pilot randomized controlled trial testing an interventiont to improve transitions to adult survivorship care among active childhood cancer survivors (CCS) who are newly adults.

Aim: Develop and test a multilevel intervention to improve rates of follow-up visit completion among CCS transitioning from pediatric survivorship care to one of three adult onco-primary care clinics.

Hypothesis: Adult CCS receiving nurse navigation, education, and electronic referral will be more likely to complete follow-up visits at an adult onco-primary care clinic than those on standard referral pathways (electronic referral only).

02

Conditions studied

  • Childhood Cancer Survivors
  • Adolescent and Young Adult Cancer Survivors
  • Primary Care

Keywords

  • nurse navigation
  • transition
03

In context

Lead sponsor

University of Texas Southwestern Medical Center is the lead sponsor of 1,012 studies on the registry; 201 are open to participants now.

Of its 139 completed or terminated interventional studies of FDA-regulated products, 105 (76%) have results posted.

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

04

Who can participate

Ages eligible
18 Years and older
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

  • Are scheduled for a final pediatric survivorship visit after the study's enrollment start (target: March 2027) but within 1 month of eligibility assessment date,
  • Completed cancer treatment >30 months prior to eligibility assessment date,
  • Are at least 18 years old at eligibility assessment date, and
  • Are able to independently understand, and willing to sign, a written document.

Exclusion criteria

Exclusion Criteria:

  • Were treated for non-cancer diagnoses (e.g., received chemotherapy or radiation for another non-cancer condition, e.g., aplastic anemia), or
  • Do not want to attend onco-primary care at UTSW (i.e., have a different planned clinician or clinic for survivorship care).
  • Speak or write a language other than English or Spanish
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
100 participants (estimated)

Study arms

  • Experimental
    Enhanced Referral Pathway (ERP)

    Participants randomized to the ERP arm will receive the SRP, tailored patient education, and patient navigation mapped to the four components of patient navigation

    Behavioral: Nurse navigation and patient education

  • No intervention
    Standard Referral Pathway (SRP)

    For the SRP, clinicians will send an electronic Care Everywhere referral to the adult onco-primary care program, via the ACE coordinator, an existing clinical staff member in onco-primary care. The coordinator will attempt to contact the adult participant 3 times by telephone or MyChart, which includes text messages. Once contact is made, the ACE coordinator will assess current insurance status and schedule a visit in one of the three onco-primary care clinics depending on patient preference, location, and insurance type

Interventions

  • BehavioralNurse navigation and patient education

    A nurse navigator trained in patient navigation and motivational interviewing will contact CCS (childhood cancer survivor) randomized to the ERP arm and provide a brief introduction to the importance of survivorship care and schedule the patient for an appointment at an adult onco-primary care clinic. The nurse navigator will also schedule at an initial one-hour telehealth visit with the CCS for \~1 month after their last Pediatric ACE visit. During the initial telehealth visit, the navigator will provide tailored patient education and individualized navigation based on the baseline survey results for each adult CCS. The navigator will assess additional educational needs or barriers to determine whether additional visits are needed. Every CCS in the ERP arm will have at least one telehealth visit, but may have as many as five, as needed.

06

What researchers measure

Primary outcomes

  1. Proportion of participants with who attend an adult onco-primary care visit

    The proportion of participants in each arm who attend an onco-primary care visit. Visit attendance will be assessed through clinic scheduling data. The outcome will be analyzed as a binary proportion (attended vs. did not attend)

    Time frame: Within 24 months after study enrollment

Secondary outcomes

  1. Proportion of participants with who schedule an adult onco-primary care visit

    The proportion of participants in each arm who schedule an onco-primary care visit. Visit scheduling will be assessed through clinic scheduling data. The outcome will be analyzed as a binary proportion (scheduled vs. did not schedule)

    Time frame: Within 24 months after study enrollment

  2. Change in transition readiness

    Change in score on the the Transition Readiness Assessment for Youth scale. The scale includes twenty readiness items rated as No (0), I want to learn (1), or Yes (2). The items will be summed and the outcome will be analyzed as a scale variable ranging from 0 (lowest readiness) to 40 (highest readiness)

    Time frame: Assessed at baseline, after navigation appointment, and annually until study end

  3. Change in health care self-efficacy

    Assessed via the Healthcare Self-Efficacy Scale (3-item instrument). The items are rated on a 3-point Likert-type scale: (1) not confident, (2) confident, (3) very confident. The items will be averaged and the outcome will be anaylzed as scale variable ranging from 1 (least confident) to 3 (most confident).

    Time frame: Assessed at baseline, after navigation appointment, and annually until study end

  4. Proportion of participants with who attended a primary care visit

    The proportion of participants who complete a qualifying primary care visit, defined as: a visit with any primary care or a visit to an onco-primary care clinic. Self-reported by participants and assessed through onco-primary care clinic scheduling data. The outcome will be analyzed as a binary proportion (attended primary care vs. did not attend primary care).

    Time frame: Assessed at baseline, after navigation appointment, and annually until study end

07

Study locations

1 site
08

References and documents

Publications

  • Shay LA, Parsons HM, Vernon SW. Survivorship Care Planning and Unmet Information and Service Needs Among Adolescent and Young Adult Cancer Survivors. J Adolesc Young Adult Oncol. 2017 Jun;6(2):327-332. doi: 10.1089/jayao.2016.0053. Epub 2017 Jan 19. PubMed 28103126 ↗
  • Balasubramanian BA, Booker QS, Berry A, Zhu H, Ward R, Eary R, Sadeghi N, Lee SC. (Not) Lost in Transition-Enhancing Patient-Reported Care Coordination by Bridging Oncology and Primary Care for Breast and Colorectal Cancer Survivors. JCO Oncol Pract. 2026 May 19:OP2501275. doi: 10.1200/OP-25-01275. Online ahead of print. PubMed 42155068 ↗
  • Millett ME, Malthaner LQ, McCallister K, Craig DW, Eary R, Valerio-Shewmaker MA, Shay LA, Rajan SS, Ma HY, Ghosh S, Crabtree BF, Lee SJC, Balasubramanian BA. Community and Academic Synergy for Cancer Survivorship Care Delivery Enhancement (Project CASCADE): a study protocol for a pragmatic, stepped-wedge, cluster-randomized trial in Texas primary care community health centers. BMC Prim Care. 2025 Dec 27;27(1):18. doi: 10.1186/s12875-025-03108-1. PubMed 41454266 ↗
  • Betts AC, Jacobs A, Overholt N, Russell J, Shear D, Smith McGuire E, Shi M, Harbison B, Eary R, Rodriguez SA, Hall B. "I felt so seen": Perspectives on age-appropriate, needs-based survivorship care among young adult survivors of childhood, adolescent, or young adult cancers (CAYA). Support Care Cancer. 2026 Feb 17;34(3):215. doi: 10.1007/s00520-026-10369-8. PubMed 41703300 ↗
  • Booker Q, Eary R, Gonzalez V, Muquith M, Dev P, Lee SJC, Balasubramanian BA. Patient history of cancer in primary care: a closer look among cancer survivors with chronic conditions in federally qualified health centers. BMC Prim Care. 2025 Feb 12;26(1):39. doi: 10.1186/s12875-025-02727-y. PubMed 39939910 ↗
  • Eary R, Betts AC, Hughes A, Lawrence S, Shliakhtsitsava K, Thakur B, Ho E, Balasubramanian BA, Woods S, Shay LA, Hall B. Age-appropriate needs-based care in an onco-primary care survivorship program for survivors of childhood, adolescent and young adult, and adult cancers. J Cancer Surviv. 2026 Oct;20(5):2318-2328. doi: 10.1007/s11764-025-01919-w. Epub 2025 Nov 20. PubMed 41264205 ↗
  • Betts AC, Eary R, Thakur B, Hughes A, Booker QS, Shay LA, Lee SC, Bowers DC, Balasubramanian BA. Lack of Routine Health Care Among Adult Survivors of Childhood, Adolescent, and Young Adult Cancers (CAYA): A Nationally Representative Study of 4300 Survivors. Cancer Med. 2025 May;14(9):e70924. doi: 10.1002/cam4.70924. PubMed 40331733 ↗
  • Hong AS, Hughes A, Courtney DM, Fullington H, Craddock Lee SJ, Sweetenham JW, Sadeghi N, Zhang S, Bazzell A, Halm EA. Characteristics of self-triaged emergency department visits by adults with cancer. Am J Manag Care. 2023 Sep 1;29(9):e267-e273. doi: 10.37765/ajmc.2023.89429. PubMed 37729532 ↗
  • Shliakhtsitsava K, Eary R, Hughes A, Betts AC, Cochran C, Eshelman-Kent D, Lawrence S, McCaskill T, Packard C, Bowers DC. The Development of a Dynamic Electronic Health Records Database for Childhood Cancer Survivors at a Single Institution: 30 Years of Data for Clinical and Research Applications. Pediatr Blood Cancer. 2025 Oct;72(10):e31882. doi: 10.1002/pbc.31882. Epub 2025 Jul 8. PubMed 40629666 ↗

Individual participant data

Plan to share: Undecided

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Apr 2027; primary completion for Aug 2030, 40 months later.

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

Registered
Nov 6, 2026
First posted
Nov 12, 2026
StartEst.
Apr 1, 2027
Primary completionEst.
Aug 31, 2030
CompletionEst.
Aug 31, 2030
Last update
Nov 12, 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.
Registered
First appeared on the registry. No changes since
Nov 12, 2026
Show all 1 update
  1. Nov 12, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07934329
Responsible party
Rebecca Eary (Associate Professor, University of Texas Southwestern Medical Center) — Principal investigator
First posted
Nov 12, 2026
Start date
Apr 1, 2027 (estimated)
Primary completion
Aug 31, 2030 (estimated)
Completion
Aug 31, 2030 (estimated)
Last update
Nov 12, 2026

Study contacts

Study Coordinator
Contact
Leo.Gonzalez@UTSouthwestern.edu
214-648-1619
Rebecca Eary, DO, MPH
principal investigator · University of Texas Southwestern Medical Center
Amy E Hughes, PhD, MPH
principal investigator · University of Texas Southwestern Medical Center
L. Aubree Shay, PhD, MSSW
principal investigator · The University of Texas Health Science Center, Houston

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 Oct 2026. You cannot join it, but the record below documents what was studied.

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