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Cognitive Support Program for Patients With Brain Metastases

2019年4月15日 更新者：University Health Network, Toronto
This study evaluates the feasibility and preliminary efficacy of a brief cognitive-behavioural program designed to improve cognitive functioning in people with brain metastases.

調査の概要

状態

完了

条件

介入・治療

詳細な説明

Cognitive impairments (such as problems with attention, executive functions, memory and language abilities) are common in people with brain metastases as a result of disease and/or treatment effects. These impairments can significantly limit functional independence, participation in valued roles and activities, and overall quality of life.

Building on research in other cognitively-impaired populations, we designed a brief, structured, patient-centered Cognitive Support Program (CSP) for brain metastases patients, who have the option of participating with a caregiver. Program contents include supportive psychoeducation, mindfulness practice, and strategy training (e.g., strategies to improve memory or concentration). This prospective, single-arm study will enroll 24 brain metastases patients to evaluate the feasibility and preliminary efficacy of the CSP. A battery of outcome measures is administered (1) prior to intervention, (2) after completing the CSP, and (3) after an additional 3 months to evaluate longer-term outcomes. Feasibility assessment will include program retention and adherence. Reliable change analyses will examine treatment effects, with regression analyses to explore moderating effects of select patient, disease and treatment factors (e.g., severity of baseline cognitive impairment, number of brain lesions, cranial radiation dose and distribution). Results of this trial will inform further development and implementation of evidence-based supportive care for cognitively-impaired brain metastases patients.

研究の種類

介入

入学 (実際)

18

段階

  • 適用できない

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究場所

  • カナダ
    • Ontario
      • Toronto、Ontario、カナダ、M5S1W8
        • Princess Margaret Cancer Centre

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

18年～90年 (大人、高齢者)

健康ボランティアの受け入れ

いいえ

受講資格のある性別

全て

説明

Inclusion Criteria:

  • age 18 or older
  • able to provide informed consent to all procedures
  • diagnosis of one or more brain metastases, with primary cancer outside the CNS
  • indication of cognitive deficits from self-report and/or cognitive testing
  • interest in participating in a cognitive rehabilitation program
  • able to complete study activities

Exclusion Criteria:

  • concurrent non-cancer-related neurological or major psychiatric disorder or other medical condition suspected to influence cognition

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

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 Support Program
Three individual sessions of supportive psychoeducation, mindfulness practice, and strategy training (e.g., strategies to improve memory or concentration), with practice applying program content between sessions.
行動：Cognitive Support Program
Three individual sessions of supportive psychoeducation, mindfulness practice, and strategy training (e.g., strategies to improve memory or concentration), with practice applying program content between sessions.

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
Functional Assessment of Cancer Therapy - Cognitive
時間枠：Baseline; 2 months (0-2 weeks post-training); 5 months (3 months post-training)
Multi-domain cognitive symptom questionnaire completed at each time point. Raw scores are converted to z-scores (M = 0, SD = 1, higher scores = better functioning) according to published criteria, and change from baseline to post-training and to 3-month follow-up calculated by subtraction.
Baseline; 2 months (0-2 weeks post-training); 5 months (3 months post-training)

二次結果の測定

結果測定
メジャーの説明
時間枠
Frontal Systems Behavior Scale
時間枠：Baseline; 2 months (0-2 weeks post-training); 5 months (3 months post-training)
Executive cognitive symptom questionnaire completed at each time point. Raw scores are converted to z-scores (M = 0, SD = 1, higher scores = better functioning) according to published criteria, and change from baseline to post-training and to 3-month follow-up calculated by subtraction.
Baseline; 2 months (0-2 weeks post-training); 5 months (3 months post-training)
Hopkins Verbal Learning Test - Revised
時間枠：Baseline; 2 months (0-2 weeks post-training); 5 months (3 months post-training)
Neurocognitive test of memory completed at each time point. Raw scores are converted to z-scores (M = 0, SD = 1, higher scores = better functioning) according to published criteria, and change from baseline to post-training and to 3-month follow-up calculated by subtraction.
Baseline; 2 months (0-2 weeks post-training); 5 months (3 months post-training)
Trail Making Test
時間枠：Baseline; 2 months (0-2 weeks post-training); 5 months (3 months post-training)
Neurocognitive test of processing speed and executive function completed at each time point. Raw scores are converted to z-scores (M = 0, SD = 1, higher scores = better functioning) according to published criteria, and change from baseline to post-training and to 3-month follow-up calculated by subtraction.
Baseline; 2 months (0-2 weeks post-training); 5 months (3 months post-training)
Wechsler Digit Span Test
時間枠：Baseline; 2 months (0-2 weeks post-training); 5 months (3 months post-training)
Neurocognitive test of working memory completed at each time point. Raw scores are converted to z-scores (M = 0, SD = 1, higher scores = better functioning) according to published criteria, and change from baseline to post-training and to 3-month follow-up calculated by subtraction.
Baseline; 2 months (0-2 weeks post-training); 5 months (3 months post-training)
BADS Zoo Map Test
時間枠：Baseline; 2 months (0-2 weeks post-training); 5 months (3 months post-training)
Neurocognitive test of executive function completed at each time point. Raw scores are converted to z-scores (M = 0, SD = 1, higher scores = better functioning) according to published criteria, and change from baseline to post-training and to 3-month follow-up calculated by subtraction.
Baseline; 2 months (0-2 weeks post-training); 5 months (3 months post-training)
Controlled Oral Word Association Test
時間枠：Baseline; 2 months (0-2 weeks post-training); 5 months (3 months post-training)
Neurocognitive test of verbal fluency completed at each time point. Raw scores are converted to z-scores (M = 0, SD = 1, higher scores = better functioning) according to published criteria, and change from baseline to post-training and to 3-month follow-up calculated by subtraction.
Baseline; 2 months (0-2 weeks post-training); 5 months (3 months post-training)
Functional Assessment of Cancer Therapy - Brain
時間枠：Baseline; 2 months (0-2 weeks post-training); 5 months (3 months post-training)
Health-related quality of life questionnaire completed at each time point. Raw scores are converted to z-scores (M = 0, SD = 1, higher scores = better functioning) according to published criteria, and change from baseline to post-training and to 3-month follow-up calculated by subtraction.
Baseline; 2 months (0-2 weeks post-training); 5 months (3 months post-training)
Positive and Negative Affect Schedule
時間枠：Baseline; 2 months (0-2 weeks post-training); 5 months (3 months post-training)
Quality of life (well-being) questionnaire completed at each time point. Raw scores are converted to z-scores (M = 0, SD = 1, higher scores = better functioning) according to published criteria, and change from baseline to post-training and to 3-month follow-up calculated by subtraction.
Baseline; 2 months (0-2 weeks post-training); 5 months (3 months post-training)
Hospital Anxiety and Depression Scale
時間枠：Baseline; 2 months (0-2 weeks post-training); 5 months (3 months post-training)
Quality of life (psychological distress) questionnaire completed at each time point. Raw scores are converted to z-scores (M = 0, SD = 1, higher scores = better functioning) according to published criteria, and change from baseline to post-training and to 3-month follow-up calculated by subtraction.
Baseline; 2 months (0-2 weeks post-training); 5 months (3 months post-training)
Illness Intrusiveness Rating Scale
時間枠：Baseline; 2 months (0-2 weeks post-training); 5 months (3 months post-training)
Quality of life (activity participation) questionnaire completed at each time point. Raw scores are converted to z-scores (M = 0, SD = 1, higher scores = better functioning) according to published criteria, and change from baseline to post-training and to 3-month follow-up calculated by subtraction.
Baseline; 2 months (0-2 weeks post-training); 5 months (3 months post-training)

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

University Health Network, Toronto

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2017年7月1日

一次修了 (実際)

2018年11月28日

研究の完了 (実際)

2018年11月28日

試験登録日

最初に提出

2018年4月21日

QC基準を満たした最初の提出物

2018年5月15日

最初の投稿 (実際)

2018年5月25日

学習記録の更新

投稿された最後の更新 (実際)

2019年4月17日

QC基準を満たした最後の更新が送信されました

2019年4月15日

最終確認日

2019年4月1日

詳しくは

本研究に関する用語

追加の関連 MeSH 用語

その他の研究ID番号

  • 16-6056

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いいえ

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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。

Metastases, CNSの臨床試験

Cognitive Support Programの臨床試験

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