An Investigation of Chemotherapy Induced Cognitive Impairments in Breast Cancer Survivors
2018年2月2日 更新者：NYU Langone Health
An Investigation of Chemotherapy Induced Cognitive Impairments in Breast Cancer
The main goal of this project is to identify and remediate the cognitive difficulties, including processing speed and attention deficits in individuals who have undergone chemotherapy treatment. Recent research has demonstrated objective cognitive deficits following chemotherapy and that it is not an emotional reaction to the cancer diagnosis as it was once considered. There are a large number of woman diagnosed and treated for breast cancer that experience chemotherapy induced cognitive deficits.
Subjects who participate in the study will be evaluated for cognitive abilities prior to chemotherapy treatment and after completion of chemotherapy. Participants will then have the option to participate in the second phase of the study, which involves the use of a computer-based Brain Fitness Program for 12 weeks. This is followed by another cognitive evaluation.
調査の概要
研究の種類
介入
入学 (実際)
11
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
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New York
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New York、New York、アメリカ、10016
- NYU Perlmutter Cancer Center
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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～70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
女性
説明
Inclusion Criteria:
- Diagnosis of breast cancer with adjuvant chemotherapy treatment
- all subjects will be between the ages of 18 and 70 years old
- free from significant psychiatric history
- free of current alcohol or drug abuse.
- All participants need to understand and read English and have the capacity to consent.
Exclusion Criteria:
- Individuals with pre-exiting neurological disorder (i.e. brain tumors, dementia, Parkinson's disease, multiple sclerosis, seizure disorder) or diagnosed with metastasis cancer.
- Individuals younger than 18 years old and older than 70 years old will also be excluded due to developmental changes that occur in those years.
- Individuals with a current substance use disorder will also be excluded.
- Individuals who lack the capacity to consent will be excluded from this study.
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 |
|---|---|
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実験的：Breast cancer patients receiving chemotherapy treatment
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The program is designed to improve processing speed of auditory information and attention.
The BFP is comprised of six computerized subtests that continuously adjust in the level of difficulty to maintain an 85% correct response rate.
The subtest exercises include discrimination of confusable syllables, recognition of sequences of syllables, matching pairs of confusable syllables, reconstruction of sequences of verbal instructions and identification of details in a verbally presented story.
Participants will participate in 40 one-hour training sessions over a 12 week period to complete all cognitive remediation training sessions.
Since this intervention is presented both visually and verbally, noise cancelling headphones will be provided to the participants.
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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 Wechsler Test of Adult Reading (WTAR)
時間枠：Difference from baseline to end of chemotherapy (approximately 4 months, depending on individual treatment); difference from end of chemotherapy to 12 weeks post-chemotherapy
|
The WTAR is a measure that reliably estimates levels of intelligence by asking the subject to read aloud the words on an established reading list.
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Difference from baseline to end of chemotherapy (approximately 4 months, depending on individual treatment); difference from end of chemotherapy to 12 weeks post-chemotherapy
|
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Change in Processing Speed (PS)
時間枠：Difference from baseline to end of chemotherapy (approximately 4 months, depending on individual treatment); difference from end of chemotherapy to 12 weeks post-chemotherapy
|
1) The Paced Auditory Serial Addition Test (PASAT), which assesses complex mental manipulation of verbally presented single digit numbers.
The task requires the participant to mentally add and verbally express the last two numbers presented.
There are 60 trials in each of the two sets of numbers that are presented at two different speeds; 2) Symbol-Digit Modality Test requires that the subject copies numbers that are paired with symbols within a specified time limit.
The coding subtest involves processing speed, short term visual memory, psychomotor speed, visual perception and visual scanning ability.
3) The Stroop Test has three parts to it: the first task requires the participant to respond to every word as quickly as possible that is presented on the computer screen.
The second task requires a response when the color word matches the meaning of the word.
The third task requires a response when the color of the word does not match the meaning of the word.
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Difference from baseline to end of chemotherapy (approximately 4 months, depending on individual treatment); difference from end of chemotherapy to 12 weeks post-chemotherapy
|
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Change in Executive Functions
時間枠：Difference from baseline to end of chemotherapy (approximately 4 months, depending on individual treatment); difference from end of chemotherapy to 12 weeks post-chemotherapy
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The Trail Making Test, Part A & B: are measures of visual search efficiency and set shifting while alternating between letters and numbers.
Additionally, the Verbal Fluency subtest of the Delis-Kaplan Executive Functioning Scale (D-KEFS) will be used to measure semantic and phonemic fluency through a task of word naming, where subjects are asked to list as many words as they can within 60-second time limit that begin with a specific letter (i.e., F, A, and S), and a task of category naming, where subjects are asked to list as many words as they can within 60-second time limit that fall within a specified category (i.e., animals and boy's names), respectfully.
This subtest also measures category switching ability via a task where subjects are asked to list as many words as they can within 60-second time that fall within two alternating categories (i.e., fruits/furniture).
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Difference from baseline to end of chemotherapy (approximately 4 months, depending on individual treatment); difference from end of chemotherapy to 12 weeks post-chemotherapy
|
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Change in Working Memory and Attention
時間枠：Difference from baseline to end of chemotherapy (approximately 4 months, depending on individual treatment); difference from end of chemotherapy to 12 weeks post-chemotherapy
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1) Digit-Span Task, this is a standardized measure of verbal working memory in which participants recall a string of numbers that are verbally presented.
2) The Continuous Performance subtest of the CNS Vital Signs neurocognitive battery.
The Continuous Performance test assesses sustained attention and reaction time to targets presented on the computer by requiring the participant to respond only when a specific designated letter is presented during a 5 minute trial.
3) The Shifting Attention subtest of the CNS- Vital Signs neurocognitive battery will be administered to assess the participant's ability to maintain attention while switching between sets of target.
4) Four-Parts Continuous performance subtest of the CNS Vital Signs neurocognitive battery, which is a measure of working memory and sustained attention.
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Difference from baseline to end of chemotherapy (approximately 4 months, depending on individual treatment); difference from end of chemotherapy to 12 weeks post-chemotherapy
|
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Change in Visual and Verbal Memory
時間枠：Difference from baseline to end of chemotherapy (approximately 4 months, depending on individual treatment); difference from end of chemotherapy to 12 weeks post-chemotherapy
|
Verbal memory will be assessed with the California Verbal Learning Test (CVLT-II) which assesses learning and rote memory of verbal material.
Subjects are verbally presented with a list of words that are assessed immediately and after a 20-minute delay with and without cues.
The short form version of this test will be used.
The Visual Memory subtest of the CNS- Vital Signs neurocognitive battery will be administered to assess non-verbal memory of immediate and delayed recall.
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Difference from baseline to end of chemotherapy (approximately 4 months, depending on individual treatment); difference from end of chemotherapy to 12 weeks post-chemotherapy
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Change in Depression
時間枠：Difference from baseline to end of chemotherapy (approximately 4 months, depending on individual treatment); difference from end of chemotherapy to 12 weeks post-chemotherapy
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Beck Depression Inventory -II: This is a standardized instrument for the assessment of depression with a self-report questionnaire.
Participants will endorse the level of disturbance which best describe their mood over 21 items that are characteristic of depression.
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Difference from baseline to end of chemotherapy (approximately 4 months, depending on individual treatment); difference from end of chemotherapy to 12 weeks post-chemotherapy
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Change in Anxiety
時間枠：Difference from baseline to end of chemotherapy (approximately 4 months, depending on individual treatment); difference from end of chemotherapy to 12 weeks post-chemotherapy
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Beck Anxiety Inventory (BAI): The BAI is a self-report instrument for the assessment of anxiety.
The BAI consists of 21 items, each describing a common symptom of anxiety on which the respondent rates how much they have been bothered by the symptoms over the last week.
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Difference from baseline to end of chemotherapy (approximately 4 months, depending on individual treatment); difference from end of chemotherapy to 12 weeks post-chemotherapy
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Change in Frontal Systems Behavior Scale (FRSBE)
時間枠：Difference from baseline to end of chemotherapy (approximately 4 months, depending on individual treatment); difference from end of chemotherapy to 12 weeks post-chemotherapy
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A validated self-report of three frontal systems behavioral syndromes: apathy, disinhibition, and executive dysfunction.
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Difference from baseline to end of chemotherapy (approximately 4 months, depending on individual treatment); difference from end of chemotherapy to 12 weeks post-chemotherapy
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Change in Cognitive Self-Report Questionnaire (CSRQ)
時間枠：Difference from baseline to end of chemotherapy (approximately 4 months, depending on individual treatment); difference from end of chemotherapy to 12 weeks post-chemotherapy
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A validated self-report questionnaire that assesses perceptions of cognition and mood related to everyday experiences for the past two weeks
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Difference from baseline to end of chemotherapy (approximately 4 months, depending on individual treatment); difference from end of chemotherapy to 12 weeks post-chemotherapy
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Change in Functional Assessment of Cancer Therapy-Cognitive Scale (FACT-Cog)
時間枠：Difference from baseline to end of chemotherapy (approximately 4 months, depending on individual treatment); difference from end of chemotherapy to 12 weeks post-chemotherapy
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Measures patient's perceived cognitive functioning as a result of their diagnosis and cancer therapy.
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Difference from baseline to end of chemotherapy (approximately 4 months, depending on individual treatment); difference from end of chemotherapy to 12 weeks post-chemotherapy
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Change in Functional Assessment of Cancer Therapy - Fatigue scale (FACIT-F)
時間枠：Difference from baseline to end of chemotherapy (approximately 4 months, depending on individual treatment); difference from end of chemotherapy to 12 weeks post-chemotherapy
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A measure of one's perception of their level of Fatigue as a result to cancer therapy.
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Difference from baseline to end of chemotherapy (approximately 4 months, depending on individual treatment); difference from end of chemotherapy to 12 weeks post-chemotherapy
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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
捜査官
- 主任研究者：Gerald Voelbel, PhD、New York University
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)
2013年9月1日
一次修了 (実際)
2016年8月1日
研究の完了 (実際)
2018年1月1日
試験登録日
最初に提出
2015年7月28日
QC基準を満たした最初の提出物
2015年8月3日
最初の投稿 (見積もり)
2015年8月4日
学習記録の更新
投稿された最後の更新 (実際)
2018年2月6日
QC基準を満たした最後の更新が送信されました
2018年2月2日
最終確認日
2018年2月1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。
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