Study of Attention and Memory Treatments for Cancer Survivors
A Pilot Study of A Novel Cognitive Intervention for Cancer Survivors
調査の概要
状態
詳細な説明
PRIMARY OBJECTIVES:
I. Determine the recruitment and retention rates for both arms of this study. II. Determine the effect size for changes in cognitive function (i.e., Test of Variables of Attention (TOVA) [i.e. attention], Adaptive Cognitive Evaluation (ACE) [i.e. working memory]) in the intervention group compared to the control group following the 4-week study.
III. Evaluate adherence rates for and satisfaction with the interventions. IV. Evaluate for treatment-related adverse events (e.g., nausea, motion sickness).
SECONDARY OBJECTIVE:
I. To determine effect sizes for depression, fatigue, and sleep disturbance, by comparing changes in the intervention group to changes in the control group, following the 4-week study.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients play Endeavor over 25 minutes daily 5 days a week for 4 weeks.
ARM II: Patients play Words! over 25 minutes daily 5 days a week for 4 weeks.
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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California
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San Francisco、California、アメリカ、94143
- University of California San Francisco
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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:
- Attention Function Index (AFI) score of < 7.5
- Are able to read, write, and understand English
- Ability to understand an electronic informed consent document, and the willingness to sign it
- Have a Karnofsky performance status (KPS) score of >= 50
- Have access to WiFi connection
Exclusion Criteria:
- Receiving active treatment for cancer recurrence
- Have significant cognitive impairment
- Have sensory or motor deficits that prevent them from doing the assessment and using the application
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 |
---|---|
実験的:Arm I (Endeavor)
Patients play Endeavor over 25 minutes daily 5 days a week for 4 weeks.
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Endeavor application will be utilized by participant on iPad
他の名前:
Standardized QOL questionnaire will be administered at each study visit
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アクティブコンパレータ:Arm II (Words!)
Patients play Words! over 25 minutes daily 5 days a week for 4 weeks.
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Standardized QOL questionnaire will be administered at each study visit
Words! application will be utilized by participant on iPad
他の名前:
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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 |
---|---|---|
Percentage of participants who completed the study
時間枠:Up to 6 weeks
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Completion is defined as participants who completed all 4 weeks of intervention and final assessment.
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Up to 6 weeks
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Mean change in scores on the Test of Variables of Attention (TOVA) over time
時間枠:Up to 4 weeks
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The TOVA records responses to visual or auditory stimuli through the participants iPAD, with a unique, highly accurate +/1 millisecond (ms) microswitch.
The TOVA (Copyright 1991- 2021 by The TOVA Company) automatically calculates response time variability (consistency), response time (speed), commissions (impulsivity), and omissions (focus and vigilance).
Results are reported as standard scores (average = 100 with a standard deviation of 15) and are compared to a large normative sample stratified by gender and age.
Scores above 85 are within normal limits, 80-85 are borderline, and below 80 are not within normal limits.
The mean change in scores will be estimated as the norm-based standardized difference in means from enrollment (Week 1) to the last assessment (Week 4).
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Up to 4 weeks
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Percent change in scores on the TOVA over time
時間枠:Up to 4 weeks
|
The TOVA records responses to visual or auditory stimuli through the participants iPAD, with a unique, highly accurate +/1 millisecond (ms) microswitch.
The TOVA (Copyright 1991- 2021 by The TOVA Company) automatically calculates response time variability (consistency), response time (speed), commissions (impulsivity), and omissions (focus and vigilance).
Results are reported as standard scores (average = 100 with a standard deviation of 15) and are compared to a large normative sample stratified by gender and age.
Scores above 85 are within normal limits, 80-85 are borderline, and below 80 are not within normal limits.
Will be estimated as the standardized difference between the groups in the percent score change from enrollment (Week 1) to the last assessment (Week 4).
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Up to 4 weeks
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Mean changes in Adaptive Cognitive Evaluation (ACE)
時間枠:Up to 4 weeks
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The ACE is a mobile cognitive control assessment battery containing standard tests that assess different aspects of cognitive control (attention, working memory, and goal management), modified by incorporating adaptive algorithms, immersive graphics, video tutorials, motivating feedback, and a user-friendly interface.
The ACE is administered to all participants via iPad and the scores will be estimated as the standardized difference in means from enrollment (Week 1) to the last assessment (Week 4).
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Up to 4 weeks
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Percent change in scores on the ACE over time
時間枠:Up to 4 weeks
|
The ACE is a mobile cognitive control assessment battery containing standard tests that assess different aspects of cognitive control (attention, working memory, and goal management), modified by incorporating adaptive algorithms, immersive graphics, video tutorials, motivating feedback, and a user-friendly interface.
The ACE is administered to all participants via iPad and the scores will be estimated as the standardized difference between the groups in the percent score change from enrollment (Week 1) to the last assessment (Week 4).
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Up to 4 weeks
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Proportion of time using application
時間枠:Up to 4 weeks
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Adherence rate will be evaluated by comparing the amount of time the participant should have used the application to the actual amount of time the participant used the application.
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Up to 4 weeks
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Percentage of participants who experienced treatment-related adverse events
時間枠:Up to 6 weeks
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Safety analyses will involve examination of and comparison between groups for the percentage of participants by adverse event severity and type of treatment-related adverse events.
Comparisons of the frequencies between groups will be conducted using Chi-square or Fisher's exact test.
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Up to 6 weeks
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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 |
---|---|---|
Change in mean severity scores on the Center for Epidemiologic Studies - Depression Scale (CES-D)
時間枠:Up to 4 weeks
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The CES-D scale is a brief self-report scale designed to measure self-reported symptoms associated with depression experienced in the past week.
Responses are rated on a 5 point Likert scale with response option ranging 0="Rarely or none of the time (less than 1 day )" to 4='Most or all of the time (5-7 days)".
The scoring of positive items is reversed.
Possible range of scores is 0 to 60, with the higher scores indicating the presence of more symptomatology and will be estimated as the standardized difference in means of each measure at the last assessment from enrollment to the last assessment.
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Up to 4 weeks
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Change in mean severity scores on the Lee Fatigue Scale
時間枠:Up to 4 weeks
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The Lee Fatigue Scale is used to measure the impact of fatigue on a participants quality of life.
The scale consists of 18 items relating to the subjective experience of fatigue.
Each item is rated on a 0 to 10 numeric rating scale (e.g., from "not at all tired" to "extremely tired").
Scores can range from 0 to 10.
The instrument has two subscales: fatigue (items 1-5 and 11-18) and energy (items 6-10).
The fatigue subscale score is calculated as the mean of the 13 fatigue items and the energy subscale score is the mean of the 5 energy items.
Higher scores on the fatigue subscale represent greater fatigue severity, and higher scores on the energy subscale indicate higher levels of energy and will be estimated as the standardized difference in means of each measure at the last assessment from enrollment to the last assessment.
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Up to 4 weeks
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Change in severity scores on the General Sleep Disturbance Scale (GSDS)
時間枠:Up to 4 weeks
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The GSDS consists of 21 items related to frequency in the past month of difficulty getting to sleep when respondents were asked to think about the past month, and each response is on a 8-point Likert scale from 0 ("never") to 7 ("all the time").
Will be estimated as the standardized difference in means of each measure at the last assessment, and as the difference between the groups in the percent change from enrollment to the last assessment.
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Up to 4 weeks
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協力者と研究者
捜査官
- 主任研究者:Christine Miaskowski, RN, PhD、University of California, San Francisco
研究記録日
主要日程の研究
研究開始 (実際)
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 (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
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
- 19803
- NCI-2021-02024 (レジストリ識別子:CTRP (Clinical Trial Reporting Program))
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
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