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).
調査の概要
状態
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前:Study Coordinator
- 電話番号:214-648-1619
- メール:Leo.Gonzalez@UTSouthwestern.edu
研究場所
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Texas
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Dallas、Texas、アメリカ、75390
- University of Texas Southwestern Medical Center
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コンタクト:
- Study Coordinator
- 電話番号:214-648-1619
- メール:Leo.Gonzalez@UTSouthwestern.edu
-
-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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
研究計画
研究はどのように設計されていますか?
デザインの詳細
- 主な目的:処理
- 割り当て:ランダム化
- 介入モデル:並列代入
- マスキング:なし(オープンラベル)
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的: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. |
|
介入なし: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 |
この研究は何を測定していますか?
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Proportion of participants with who attend an adult onco-primary care visit
時間枠:Within 24 months after study enrollment
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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
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Proportion of participants with who schedule an adult onco-primary care visit
時間枠: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
|
|
Change in transition readiness
時間枠: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
|
|
Change in health care self-efficacy
時間枠:Assessed at baseline, after navigation appointment, and annually until study end
|
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
|
|
Proportion of participants with who attended a primary care visit
時間枠: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
|
協力者と研究者
捜査官
- 主任研究者:Rebecca Eary, DO, MPH、University of Texas Southwestern Medical Center
- 主任研究者:Amy E Hughes, PhD, MPH、University of Texas Southwestern Medical Center
- 主任研究者:L. Aubree Shay, PhD, MSSW、The University of Texas Health Science Center, Houston
出版物と役立つリンク
一般刊行物
- 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.
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
キーワード
追加の関連 MeSH 用語
その他の研究ID番号
- STU20261556
- R01CA303339 (米国 NIH グラント/契約)
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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