Cognitive Intervention After a Brain Tumor
調査の概要
詳細な説明
Cognitive impairments (including problems with attention, memory or executive functions) are common in people with brain tumors, as a result of the disease and/or treatment effects. These deficits, even when relatively mild, can interfere with interpersonal relationships, occupational activities, functional independence, and quality of life. They may also contribute to caregiver burden.
Building on research in other cognitively-impaired populations, in this study we compare two behavioural interventions. The Brain Training (BT) and Brain Health (BH) interventions each offer a structured yet client-centered program through 8 weekly individual treatment sessions and between-session exercises. Contents include mindfulness practice, strategy training, and supportive psychoeducation including counseling around lifestyle factors to promote brain functioning.
Using a prospective randomized controlled design, 54 brain tumor patients are being enrolled in one of three study arms: BT, BH, or standard care (wait-list control). A battery of outcome measures is being administered (1) prior to intervention, (2) after the 8-week behavioural intervention (or wait-list) period, and (3) after an additional 4 months to evaluate longer-term outcomes. Analyses of variance will examine treatment effects, with regression analyses to explore moderating effects of participant demographics, severity of baseline cognitive impairment, and tumor and treatment factors (e.g., tumor location, radiation dose and distribution). Results of this trial will lay the groundwork for implementation of evidence-based supportive care to reduce and manage cognitive impairments following a brain tumor.
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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Ontario
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Toronto、Ontario、カナダ、M5S1W8
- Princess Margaret Cancer Centre
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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:
- age 18 or older
- fluent in English
- able to provide informed consent to all procedures
- diagnosis of a brain tumor
- indication of lasting post-treatment cognitive deficits (e.g., from clinical presentation, prior neuropsychological assessment, and/or self-report)
- sufficient motor and sensory functioning to complete study activities
- availability to complete all study activities
- for patients treated with cranial radiation, at least 3 months post-radiation
Exclusion Criteria:
(1) comorbid neurological or psychiatric disorder or other medical condition suspected to influence cognition
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：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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実験的：Brain Training
8-session cognitive training program
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実験的：Brain Health
8-session cognitive education program
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介入なし：コントロール
待機リスト コントロール グループ
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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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Change in cognitive composite score
時間枠：baseline, 2 months (0-2 weeks post-training), 6 months (4 months post-training)
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Summation of standardized change scores on neuropsychological tests
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baseline, 2 months (0-2 weeks post-training), 6 months (4 months post-training)
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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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Change in functional composite score
時間枠：baseline, 2 months (0-2 weeks post-training), 6 months (4 months post-training)
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Summation of standardized change scores on measures of occupational functioning
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baseline, 2 months (0-2 weeks post-training), 6 months (4 months post-training)
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Change in quality of life composite score
時間枠：baseline, 2 months (0-2 weeks post-training), 6 months (4 months post-training)
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Summation of standardized change scores on measures of affect, perceived self-efficacy, and illness burden
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baseline, 2 months (0-2 weeks post-training), 6 months (4 months post-training)
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Change in caregiver quality of life composite score
時間枠：baseline, 2 months (0-2 weeks post-training), 6 months (4 months post-training)
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Summation of standardized change scores on measures of affect and caregiver burden
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baseline, 2 months (0-2 weeks post-training), 6 months (4 months post-training)
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協力者と研究者
捜査官
- 主任研究者：Kim Edelstein, PhD、Princess Margaret Cancer Centre, University Health Network
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 (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。
Brain Training Programの臨床試験
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Children's Hospital Los AngelesRobert Wood Johnson Foundation募集
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Mental Health Services in the Capital Region, DenmarkCopenhagen Trial Unit, Center for Clinical Intervention Research; Center for Clinical Intervention...完了
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University of MinnesotaNational Institute of Mental Health (NIMH)募集精神病性障害 | 統合失調症 | 統合失調症スペクトラムおよびその他の精神病性障害 | 統合失調感情障害 | 精神病 | 統合失調感情障害 | 統合失調症性障害 | 精神病、感情的 | 精神性気分障害 | 精神病患者番号/その他アメリカ
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VA Office of Research and Development募集
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Beijing Pins Medical Co., LtdBeijing Tiantan Hospitalわからない