Computerized Intervention for Amelioration of Cognitive Late Effects Among Childhood Cancer Survivors
調査の概要
状態
条件
詳細な説明
Participants randomized to the intervention arm will complete the computerized working memory training program. This computer-based training program is completed in the home and requires approximately 30 minutes every weekday for five weeks. The program software guides the child through eight rotating exercises each day, with increasing difficulty based on the child's level of performance. Exercises train both visuospatial and verbal WM using child-friendly activities. A research team member will serve as a coach who monitors weekly progress online and offers support through weekly phone calls with the study participants and their caregivers. This individual will not complete post-intervention assessments to maintain study blind. A home computer with internet connection and speakers is required. A laptop computer and/or wireless internet access will be provided to families whose only obstacle to participation is lack of computer access or internet connectivity in the home setting. Families randomized to the WM intervention will complete a tutorial with study staff that provides instruction in using a computer, the internet and the WM training software.
The objective of this study is to investigate the benefits of this working memory intervention in a sample of childhood cancer survivors and look at brain-based changes that may occur as the result of working memory intervention. To achieve this goal, we plan to study childhood cancer survivors randomly assigned to the working memory intervention or a passive waitlist. Both groups will participate in cognitive testing pre-, post-, and six months post intervention. Intervention participants will also partake in neuroimaging exams before and after the intervention. Findings from this study have direct potential to support a nonpharmaceutical cognitive intervention for cancer survivors that is a safe and effective alternative to stimulant medications with great promise for improving quality of life.
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
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Tennessee
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Memphis、Tennessee、アメリカ、38105
- St. Jude Children's Research Hospital
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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 for Screening Phase:
- Received CNS-directed treatment (intrathecal chemotherapy or cranial irradiation) for a BT or ALL
- Infratentorial tumor location (for the BT cohort)
- Off treatment for at least one year with no evidence of recurrent or progressive disease
- Age 8-16 years inclusive at the time of enrollment
- English as the primary language
- Research participant and one parent willing to participate and provide consent/assent according to institutional guidelines
Exclusion Criteria for Screening Phase
- Significant impairment in global intellectual functioning (estimated or full scale IQ < 70 based on standardized testing routinely conducted on primary treatment protocols)
- History of CNS injury/disease predating or unrelated to cancer diagnosis
- Documented ADHD predating cancer diagnosis
- Treatment with psychostimulant or psychotropic medication within two weeks of study participation
- Major sensory or motor impairment that would preclude valid cognitive testing secondary to inability to complete study procedures (e.g., blindness, paresis, poorly controlled seizures/photosensitive epilepsy, psychosis)
Inclusion Criteria for Intervention Phase
- Signed screening consents and has undergone screening
- Fully evaluable psychological testing results (including IQ > or = 70)
- Age-scaled score on Digit Span, Letter-Number Sequencing or Spatial Span < 7 OR at least one standard deviation below IQ score
- Training aide is available to participate in required sessions
- Participant and training aide demonstrate computer proficiency
- Participant has access to or will be provided a laptop or home computer with internet connection and speakers
- Participant willing to participate in required aspects of computerized intervention
- Participant is able to take part in fMRI without sedation
Exclusion Criteria for Intervention Phase
- Major psychological condition that would preclude completion of protocol intervention (e.g., significant oppositionality, autism spectrum disorder, severe anxiety or depressive symptoms)
- Orthodontic appliances that cause MRI distortion or signal loss outside the mouth and sinus area
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：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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他の：Intervention Group
Children treated for a brain tumor (BT) or acute lymphoblastic leukemia (ALL) will complete the computerized working memory training program (intervention).
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A computer-based training program will be completed in the home.
This program requires approximately 30 minutes every weekday for five weeks.
The program software guides the child through eight rotating exercises each day, with increasing difficulty based on the child's level of performance.
Exercises train both visuospatial and verbal WM using child-friendly activities.
A research team member will serve as a coach who monitors weekly progress online and offers support through weekly phone calls with the study participants and their caregivers).
Intervention participants will also partake in neuroimaging exams before and after the intervention
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他の：Control Group
Children treated for a brain tumor (BT) or acute lymphoblastic leukemia (ALL) will complete the computerized working memory training program (control).
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Participants randomized to the control group will not complete any intervention during the intervention time period and will not partake in neuroimaging exams.
They will complete an immediate and six month post follow-up cognitive assessment.
Following completion of these assessments, they will be provided the opportunity to complete the computer-based training program off study.
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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 |
|---|---|---|
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This study will measure working memory, attention and executive functions
時間枠：Baseline, 10 weeks, and 6 months
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Participants in the working memory intervention will demonstrate significantly greater improvement from pre- to immediate post-intervention on performance- and rater-based measures of working memory relative to childhood cancer survivors placed on an intervention waitlist.
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Baseline, 10 weeks, and 6 months
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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The study will measure the maintenance of improvements on measures of working memory, attention and executive functions
時間枠：6 months.
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The improvements will be evaluated at six months following participation in the computer-based intervention program.
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6 months.
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This study will examine the neural correlates of working memory before and immediately after intervention
時間枠：Baseline and 10 weeks.
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This objective will use fMRI to examine the neural correlates of working memory before and immediately after intervention.
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Baseline and 10 weeks.
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協力者と研究者
捜査官
- 主任研究者：Heather M Conklin, Ph.D、St. Jude Children's Research Hospital
出版物と役立つリンク
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了 (実際)
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 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
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
その他の研究ID番号
- COGTRN
- 120421-RSGPB-11-009-01-CPPB (その他の助成金/資金番号：American Cancer Society)
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。