放射線治療を受けている頭頸部がん患者に対する神経認知検査とアンケートに関する研究
頭頸部がん患者における放射線関連神経認知機能のパイロット研究
The researchers are doing this study to collect more information about if, and how, neurocognitive function may be affected in people being treated with radiation therapy for head and neck cancer. Part of this study is to see if patients diagnosed with head and neck cancer who are undergoing radiation therapy are able to complete neurocognitive testing and questionnaires at 3 times over a period of 1 year.
調査の概要
研究の種類
入学 (推定)
連絡先と場所
研究連絡先
- 名前：Jonine Bernstein, PhD
- 電話番号：646-888-8241
- メール：bernstej@mskcc.org
研究連絡先のバックアップ
- 名前：Lawrence Dauer, PhD
- 電話番号：212-639-5372
研究場所
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New Jersey
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Basking Ridge、New Jersey、アメリカ、07920
- 募集
- Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)
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コンタクト：
- Jonine Bernstein, PhD
- 電話番号：646-888-8241
-
Middletown、New Jersey、アメリカ、07748
- 募集
- Memorial Sloan Kettering Monmouth (Limited Protocol Activities)
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コンタクト：
- Jonine Bernstein, MD
- 電話番号：646-888-8241
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Montvale、New Jersey、アメリカ、07645
- 募集
- Memorial Sloan Kettering Bergen (Limited Protocol Activities)
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コンタクト：
- Jonine Bernstein, PhD
- 電話番号：646-888-8241
-
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New York
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Commack、New York、アメリカ、11725
- 募集
- Memorial Sloan Kettering Suffolk- Commack (Limited Protocol Activities)
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コンタクト：
- Jonine Bernstein, PhD
- 電話番号：646-888-8241
-
Harrison、New York、アメリカ、10604
- 募集
- Memorial Sloan Kettering Westchester (Limited Protocol Activities)
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コンタクト：
- Jonine Bernstein, PhD
- 電話番号：646-888-8241
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New York、New York、アメリカ、10065
- 募集
- Memorial Sloan Kettering Cancer Center (All Protocol Activities)
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コンタクト：
- Jonine Bernstein, PhD
- 電話番号：646-888-8241
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主任研究者：
- Jonine Bernstein, PhD
-
コンタクト：
- Lawrence Dauer, PhD
- 電話番号：212-639-5372
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Rockville Centre、New York、アメリカ、11553
- 募集
- Memorial Sloan Kettering Nassau (Limited Protocol Activities)
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コンタクト：
- Jonine Bernstein, PhD
- 電話番号：646-888-8241
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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
MSK patients at any location, diagnosed with HNC (nasopharynx, maxillary sinus, tonsil, base of the tongue, oral cavity, and larynx/hypopharynx).
説明
Inclusion Criteria:
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Pathologically proven diagnosis of a head and neck cancer, specifically these subtypes: nasopharynx, maxillary sinus, tonsil, base of the tongue, oral cavity, or larynx/hypopharynx, oropharynx, cancer of unknown primary, or salivary gland.
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Ages ≥ 18 and <89 at time of diagnosis.
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Recently diagnosed with their initial head and neck cancer and able to be consented prior to OR within first week of starting standard of care radiation therapy.
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Baseline simulation whole-brain MRI or CT available as part of standard of care.
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Patients diagnosed with cancer, no distant metastases.
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Karnofsky Performance Status of >= 70 or comparable ECOG performance at enrollment.
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As per self-report, if currently taking psychoactive medications (excluding gabapentin and including but not limited to antidepressants, and anxiolytics) on a daily basis, dose must have been stable for at least two months prior to enrollment.
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English fluent as per self-reported fluency of "well' or "very well", and having a reasonable comprehension of the study conversation in the opinion of the research staff).** ** Language verification: Prior to enrollment, all patients will be asked the following two questions by the CRC to verify English fluency necessary for participation in the study:
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How well do you speak English?
Must respond "Well" or "Very well" when given the choices of:
Very well, Well, Not well, Not at all, Don't know, or Refused.
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What is your preferred language for healthcare? Must respond English.
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Exclusion Criteria:
- Patients with multiple primary head and neck cancers, carcinoma of unknown primary, or recurrence.
- Patients who previously received radiation therapy to the head and neck region as treatment for any prior cancer for any other non-cancerous condition.
- Patients who had chemotherapy within two years prior to their recent diagnosis of head and neck cancer, such as patients who received chemotherapy as treatment for any other type of cancer or received neoadjuvant chemotherapy prior to surgery to treat their recent head and neck diagnosis. Patients who receive induction chemotherapy just prior to the start of their radiation therapy or receive concurrent chemotherapy to treat their recent head and neck diagnosis are allowed
- At the discretion of the clinician, patients who are unable to comfortably speak due to symptoms of their cancer or treatment, such as surgery.
- Pre-existing diagnosis of neurodegenerative disorder that affects cognitive function (e.g. Alzheimer's disease, Parkinson's disease, Multiple Sclerosis, Dementia, Seizure Disorders, etc.).
- As per medical record or self-report, history of stroke or head injury requiring medical care, confirmed structural lesion on neuroimaging, and persistent cognitive difficulties impacting work or daily life or required cognitive rehabilitation.
- Pre-existing diagnosis of a Schizophrenia Spectrum Disorder, substance use disorder, Bipolar Disorder or Schizotypal personality disorder. Schizophrenia Spectrum Disorders include Schizophrenia, Schizophreniform disorder, Schizoaffective disorder, Delusional disorder, Brief psychotic disorder, and Attenuated Psychotic Disorder.
- Pre-existing visual or auditory impairment that would preclude ability to complete the assessments (e.g. history of significant macular degeneration or being unable to correct hearing with hearing aids)
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
- 観測モデル：COHORT
- 時間の展望：PROSPECTIVE
コホートと介入
グループ/コホート |
介入・治療 |
|---|---|
|
Phase I: Neurocognitive Tests and Questionnaires
The performance-based measures will be administered with a total completion time estimated to be 90 minutes. The neurocognitive battery is similar in content and duration to multiple previous and ongoing studies being conducted by the Neurocognitive Research Lab. |
Baseline only: WRAT Reading Test, WMS-IV Logical Memory Subtest, Hopkins Verbal Learning Test (HVLT), Oral Trailmaking - Part A and B, NAB Digit Span, Category Fluency Test, Oral Symbol Digit Modalities Test, Brief Test of Attention, FAS - Controlled Oral Word Association Test (COWAT), Verbal Naming, Enformia Cogsuite Battery Sociodemographics, Computerized Cognitive Training Programs Questionnaire, CDC Behavioral Risk Factor (Smoking Assessment), Alcohol Consumption CDC, Current Health Rating (KPS), OARS Physical Health section, COVID Medical History, Hospital Anxiety and Depression Scale (HADS), Fatigue Symptom Inventory (FSI), Functional Assessment of Cancer Therapy-General (FACT-G V4), Functional Assessment of Cancer Therapy-Cognition (FACT-Cog V3), Sensory Gating Inventory (SGI) |
|
Phase II: Neurocognitive Tests and Questionnaires
The performance-based measures will be administered with a total completion time estimated to be 90 minutes. The neurocognitive battery is similar in content and duration to multiple previous and ongoing studies being conducted by the Neurocognitive Research Lab. |
Baseline only: WRAT Reading Test, WMS-IV Logical Memory Subtest, Hopkins Verbal Learning Test (HVLT), Oral Trailmaking - Part A and B, NAB Digit Span, Category Fluency Test, Oral Symbol Digit Modalities Test, Brief Test of Attention, FAS - Controlled Oral Word Association Test (COWAT), Verbal Naming, Enformia Cogsuite Battery Sociodemographics, Computerized Cognitive Training Programs Questionnaire, CDC Behavioral Risk Factor (Smoking Assessment), Alcohol Consumption CDC, Current Health Rating (KPS), OARS Physical Health section, COVID Medical History, Hospital Anxiety and Depression Scale (HADS), Fatigue Symptom Inventory (FSI), Functional Assessment of Cancer Therapy-General (FACT-G V4), Functional Assessment of Cancer Therapy-Cognition (FACT-Cog V3), Sensory Gating Inventory (SGI) |
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 |
|---|---|---|
|
Number of newly diagnosed head and neck cancer patients recruited and retained on study
時間枠：1 year
|
have complete the neurocognitive testing |
1 year
|
協力者と研究者
捜査官
- 主任研究者：Jonine Bernstein, PhD、Memorial Sloan Kettering Cancer Center
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 (実際)
一次修了 (推定)
研究の完了 (推定)
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
- 21-498
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?
IPD プランの説明
Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.
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
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。