Measuring Brain Changes Following Cognitive Intervention in Pediatric Patients With Brain Tumors
The goal of this study is to learn if an online computerized training program improves processing speed, attention, and working memory in children with a primary brain tumor during and after active cancer treatment. The main questions it aims to answer are:
- Is the cognitive intervention feasible to administer to children with brain tumors during and after cancer treatment?,
- Is the cognitive intervention acceptable to children and caregivers?, and
- Does the cognitive intervention improve neuropsychological functioning?
There is no comparison group for this study.
Participants will:
- Complete an online computerized cognitive training program for approximately 15 minutes per day, 5 days a week, for 8 weeks;
- Have weekly check-ins with the cognitive coach,
- Complete a survey at the end of the cognitive training program, and
- Complete pre- and post- neuropsychological testing.
調査の概要
状態
条件
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：Emily J Amsden, BS
- 電話番号：215-316-2343
- メール：amsden@kennedykrieger.org
研究場所
-
-
Maryland
-
Baltimore、Maryland、アメリカ、21205
- Kennedy Krieger Institute
-
コンタクト：
- Emily J Amsden, BS
- 電話番号：215-316-2343
- メール：amsden@kennedykriger.org
-
主任研究者：
- Rachel K Peterson, PhD
-
-
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:
- Diagnosis of a primary brain tumor,
- Children and young adults 5 to 25 years of age at the time of enrollment,
- Within five years of initial brain tumor diagnosis,
- Receiving care through the Johns Hopkins neuro-oncology program.
Exclusion Criteria:
- Significant visual, hearing, motor, or cognitive impairment that precludes participation in computerized cognitive training program;
- Acute medical status (e.g., significant risk for mortality within 3-months of diagnosis).
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：支持療法
- 割り当て：なし
- 介入モデル：単一グループの割り当て
- 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：Cognitive Intervention
Computerized cognitive training program focused on processing speed. |
This online cognitive training program aims to improve processing speed through computerized cognitive exercises. Participants will complete approximately 15 minutes of training, 5 days per week for 8 weeks. Weekly check-ins with a cognitive coach will assist with engagement and problem solve any barriers. |
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 |
|---|---|---|
|
Feasibility - Enrollment
時間枠：Up to 5 years after diagnosis.
|
Study enrollment rate. |
Up to 5 years after diagnosis.
|
|
Feasibility - Participant Retention
時間枠：8 weeks
|
Number of participants who complete the computerized brain training program. |
8 weeks
|
|
Feasibility - Intervention Adherence
時間枠：Through study completion, an average of 8 weeks.
|
Number of levels completed in the cognitive training program. Qualitative feedback regarding barriers and facilitators to engagement will also we collected to provide descriptive context. |
Through study completion, an average of 8 weeks.
|
|
Feasibility - Total Intervention Time
時間枠：8 weeks
|
Total time spent completing the cognitive training program exercises. |
8 weeks
|
|
Acceptability
時間枠：At the end of the 8-week intervention.
|
Parent and self-reported acceptability measured using a Likert-scale questionnaire administered at the end of the intervention. Mean total score will be reported. Qualitative feedback regarding participant experience will also be collected to provide descriptive context. |
At the end of the 8-week intervention.
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Cognitive Training Task-Based Performance
時間枠：Prior to the intervention, immediately following intervention, and 6 months after intervention completion.
|
Changes in neuropsychological functioning, as measured by the train-to-task activity. |
Prior to the intervention, immediately following intervention, and 6 months after intervention completion.
|
|
Processing Speed
時間枠：Prior to the intervention, immediately following intervention, and 6 months after intervention completion.
|
Changes in processing speed as measured by the NIH toolbox. |
Prior to the intervention, immediately following intervention, and 6 months after intervention completion.
|
|
Attention
時間枠：Prior to the intervention, immediately following intervention, and 6 months after intervention completion.
|
Changes in attention as measured by the NIH toolbox. |
Prior to the intervention, immediately following intervention, and 6 months after intervention completion.
|
|
Working Memory
時間枠：Prior to the intervention, immediately following intervention, and 6 months after intervention completion.
|
Changes in working memory as measured by the NIH toolbox. |
Prior to the intervention, immediately following intervention, and 6 months after intervention completion.
|
協力者と研究者
捜査官
- 主任研究者：Rachel K Peterson, PhD、Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
出版物と役立つリンク
一般刊行物
- Meneses K, Benz R, Bail JR, Vo JB, Triebel K, Fazeli P, Frank J, Vance DE. Speed of processing training in middle-aged and older breast cancer survivors (SOAR): results of a randomized controlled pilot. Breast Cancer Res Treat. 2018 Feb;168(1):259-267. doi: 10.1007/s10549-017-4564-2. Epub 2017 Nov 11.
- Maeir T, Makranz C, Peretz T, Odem E, Tsabari S, Nahum M, Gilboa Y. Cognitive Retraining and Functional Treatment (CRAFT) for adults with cancer related cognitive impairment: a preliminary efficacy study. Support Care Cancer. 2023 Feb 7;31(3):152. doi: 10.1007/s00520-023-07611-y.
- Jacola LM, Peterson RK, Oswald-McCloskey KA, Sekely A, Mabbott DJ, Edelstein K. Neuropsychological function in childhood cancer patients and adult survivors of childhood cancer. J Clin Exp Neuropsychol. 2025 Oct;47(8):788-805. doi: 10.1080/13803395.2025.2521018. Epub 2025 Jul 9.
- Areklett EW, Hagen BI, Stubberud J, Fagereng E, Andersson S, Lindemann K. Digital goal management training for cognitive impairment in cervical cancer survivors-a randomized comparison study. J Cancer Surviv. 2026 Jun;20(3):978-989. doi: 10.1007/s11764-024-01701-4. Epub 2024 Nov 22.
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
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。