Cognitive Assessments in Patients With Cancer Undergoing Chemotherapy
Feasibility Study of a Cognitive Assessment Tool During Systemic Chemotherapy for Cancer Patients
調査の概要
詳細な説明
PRIMARY OBJECTIVES:
I. To assess the feasibility of administering a cognitive assessment battery in a medical oncology clinic.
SECONDARY OBJECTIVES:
I. To estimate the variability of the various cognitive tests and to assess changes in cognitive performance based on the results of cognitive assessments obtained prior to chemotherapy and at 6 to 8 weeks and 12 to 16 weeks after the initiation of chemotherapy.
II. To explore the association of cognitive performance with the Eastern Cooperative Oncology Group (ECOG) performance status as evaluated by the patient's oncology team.
III. To assess the association between cognitive performance and the occurrence of a serious adverse event during chemotherapy.
OUTLINE:
Patients complete cognitive assessments, comprising Hopkins Verbal Learning Test-Revised (HVLT-R), Trail Making Test Parts A & B (TMT-A, TMT-B), Digit Symbol Coding Test (DSC), Category Fluency Test (Animals), Montreal Cognitive Assessment (MoCA), and Digit Span Test (DST). Patients also complete the Beck Depression Inventory. Assessments are administered on day 1 of chemotherapy and at 6-8 weeks and 12-16 weeks after day 1 of chemotherapy.
研究の種類
入学 (実際)
連絡先と場所
研究場所
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North Carolina
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Winston-Salem、North Carolina、アメリカ、27157
- Wake Forest University Health Sciences
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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
サンプリング方法
調査対象母集団
説明
Inclusion Criteria:
- Patients must have histologically or cytologically confirmed cancer
- Patients are candidates for systemic chemotherapy for their cancer diagnosis
- Life expectancy must be greater than 6 months
- Ability to understand and the willingness to sign a written informed consent document
Exclusion Criteria:
- Patients who have had prior systemic chemotherapy in their lifetime
- Patients with known brain metastases should be excluded from this clinical trial because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events
- Patients may not be participating on any other study investigating cognitive function
- Patients who are non-English speaking are ineligible
- Patients with hematologic malignancies are ineligible
- Patients with primary central nervous system malignancies are ineligible
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
コホートと介入
グループ/コホート |
介入・治療 |
|---|---|
|
Supportive Care (cognitive assessment)
Patients complete cognitive assessments, comprising HVLT-R, TMT-A, TMT-B, DSC, Animals, MoCA, and DST.
Patients also complete the Beck Depression Inventory.
Assessments are administered on day 1 of chemotherapy and at 6-8 weeks and 12-16 weeks after day 1 of chemotherapy.
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補助研究
他の名前：
Given cognitive assessments
|
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 |
|---|---|---|
|
Operational and logistical feasibility of administering cognitive assessment battery in medical oncology clinic environment during administration of chemotherapy.
時間枠：Baseline to 16 weeks after the start of chemotherapy
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To determine whether cognitive assessment tools can be administered within the clinical and scheduling constraints of current chemotherapy administration practices.
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Baseline to 16 weeks after the start of chemotherapy
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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 |
|---|---|---|
|
Changes in cognition over time
時間枠：Baseline to 16 weeks after the start of chemotherapy
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As measured by cognitive assessment instruments
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Baseline to 16 weeks after the start of chemotherapy
|
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Association of cognitive performance with performance status and adverse events (AE)
時間枠：Baseline to 16 weeks after the start of chemotherapy
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Baseline to 16 weeks after the start of chemotherapy
|
協力者と研究者
捜査官
- 主任研究者：Heidi Klepin, MD、Wake Forest University Health Sciences
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 (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
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
- IRB00018421
- NCI-2011-03034 (レジストリ識別子：CTRP (Clinical Trial Reporting Program))
- CCCWFU 99611 (その他の識別子：Wake Forest University Health Sciences)
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
米国FDA規制機器製品の研究
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