- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT07934329
CCS Transitions to Adult Care
Novel Linkages and Navigation to Improve Childhood and Adolescent Cancer Survivors' Care Transitions: A Pilot Randomized Controlled Trial Across Three Health Care Systems
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).
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Tipo de estudo
Inscrição (Estimado)
Estágio
- Não aplicável
Contactos e Locais
Contato de estudo
- Nome: Study Coordinator
- Número de telefone: 214-648-1619
- E-mail: Leo.Gonzalez@UTSouthwestern.edu
Locais de estudo
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Texas
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Dallas, Texas, Estados Unidos, 75390
- University of Texas Southwestern Medical Center
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Contato:
- Study Coordinator
- Número de telefone: 214-648-1619
- E-mail: Leo.Gonzalez@UTSouthwestern.edu
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-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
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 informed consent document.
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
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
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 |
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. |
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Sem intervenção: 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 |
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Proportion of participants with who attend an adult onco-primary care visit
Prazo: Within 24 months after study enrollment
|
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) |
Within 24 months after study enrollment
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Proportion of participants with who schedule an adult onco-primary care visit
Prazo: Within 24 months after study enrollment
|
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) |
Within 24 months after study enrollment
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Change in transition readiness
Prazo: Assessed at baseline, after navigation appointment, and annually until study end
|
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) |
Assessed at baseline, after navigation appointment, and annually until study end
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Change in health care self-efficacy
Prazo: Assessed at baseline, after navigation appointment, and annually until study end
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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). |
Assessed at baseline, after navigation appointment, and annually until study end
|
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Proportion of participants with who attended a primary care visit
Prazo: Assessed at baseline, after navigation appointment, and annually until study end
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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). |
Assessed at baseline, after navigation appointment, and annually until study end
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Rebecca Eary, DO, MPH, University of Texas Southwestern Medical Center
- Investigador principal: Amy E Hughes, PhD, MPH, University of Texas Southwestern Medical Center
- Investigador principal: L. Aubree Shay, PhD, MSSW, The University of Texas Health Science Center, Houston
Publicações e links úteis
Publicações Gerais
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Estimado)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- STU20261556
- R01CA303339 (Concessão/Contrato do NIH dos EUA)
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