Neurocognitive Functioning in Patients With Newly Diagnosed Upper Aerodigestive Tract Cancer Receiving Treatment at Henry-Joyce Cancer Clinic
Neurocognitive Functioning in Adults With Upper Aerodigestive System Cancers
RATIONALE: Gathering information about how often problems with neurocognitive functioning occur in patients with newly diagnosed upper aerodigestive tract cancers may help doctors learn more about the disease.
PURPOSE: This clinical trial is studying neurocognitive functioning in patients with newly diagnosed upper aerodigestive tract cancers receiving treatment at Henry-Joyce Cancer Clinic.
調査の概要
状態
詳細な説明
OBJECTIVES:
Primary
- To establish an estimate of the prevalence of baseline neurocognitive impairment prior to initiation of outpatient cancer treatment.
- To establish an estimate of the incidence of neurocognitive impairment during outpatient cancer treatment.
- To describe how neurocognitive functioning changes over time during cancer treatment.
Secondary
- To identify sociodemographic and clinical factors associated with neurocognitive impairment.
- To examine health-related outcomes associated with neurocognitive impairment.
OUTLINE: Patients undergo interview to complete measures of domain-specific neurocognitive functioning, global neurocognitive functioning, subjective neurocognitive functioning, delirium, physical functioning, symptom prevalence and distress, mood states, and medications at baseline before initiation of cancer treatment, at scheduled treatment visits, and at the follow-up visit 3 months after completion of cancer treatment.
Measures of comorbidity, alcohol use, sensory functioning (vision and hearing), and sociodemographic are completed at baseline only. Cancer-related information (diagnosis, staging, and sites of metastasis, if applicable), treatment-related information (planned treatment regimen - chemotherapy and/or radiation therapy), and current medications are obtained at baseline by medical record review.
Health service use and complications are assessed at each scheduled treatment visit and at the 3-month post-treatment follow-up visit. Measures of domain-specific neurocognitive functioning, coping, and quality of life are completed at baseline and at the 3-month follow-up visit.
研究の種類
入学 (実際)
連絡先と場所
研究場所
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Tennessee
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Nashville、Tennessee、アメリカ、37208
- MBCCOP - Meharry Medical College - Nashville
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Nashville、Tennessee、アメリカ、37232-6838
- Vanderbilt-Ingram Cancer Center
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Nashville、Tennessee、アメリカ、37064
- Vanderbilt-Ingram Cancer Center - Cool Springs
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Nashville、Tennessee、アメリカ、37064
- Vanderbilt-Ingram Cancer Center at Franklin
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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
DISEASE CHARACTERISTICS:
- Newly diagnosed solid tumors of the upper aerodigestive system, including cancers of the head and neck, esophagus, or lung
- Receiving treatment at the Henry-Joyce Cancer Clinic at the Vanderbilt-Ingram Cancer Center
- No known brain metastasis
PATIENT CHARACTERISTICS:
- Able to hear, speak, and understand English
- No prior diagnosis of other cancer except basal cell carcinoma
PRIOR CONCURRENT THERAPY:
- No treatment plans including prophylactic cranial irradiation
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 |
|---|---|
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Treatment
Patients undergoing treatment for head and neck, lung, and esophagus cancers
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Assessment of neurocognitive function, functional status, symptom prevalence and distress, and mood alterations
Assessment of neurocognitive domains: attention/concentration, executive function, verbal learning, verbal memory, verbal fluency
Assessment of quality of life using Cantrill's Ladder at baseline and 3 months post-treatment
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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 |
時間枠 |
|---|---|
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Domain-Specific Neurocognitive Functioning measuring attention, executive functioning, mental processing speed, verbal memory, language, and visuospatial construction at baseline and 3 months after completion of treatment
時間枠：Baseline and 3 months post-treatment
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Baseline and 3 months post-treatment
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Global neurocognitive functioning as measured by the Mini-Mental State Examination (MMSE)
時間枠：Baseline, at each scheduled treatment visit, and at 3 months post-treatment
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Baseline, at each scheduled treatment visit, and at 3 months post-treatment
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Self-reported neurocognitive symptoms as measured by the Alertness Behavior Subscale of the Sickness Impact Profile
時間枠：Baseline, at each scheduled treatment visit, and at 3 months post-treatment
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Baseline, at each scheduled treatment visit, and at 3 months post-treatment
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Delirium and delirium symptoms by the NEECHAM Confusion Scale and Confusion Assessment Method (CAM)
時間枠：Baseline, at each scheduled treatment visit, and at 3 months post-treatment
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Baseline, at each scheduled treatment visit, and at 3 months post-treatment
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二次結果の測定
結果測定 |
時間枠 |
|---|---|
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Alcohol, tobacco, and drug use as measured by the Alcohol Use Disorders Identification Test (AUDIT)
時間枠：Baseline
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Baseline
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Premorbid intellectual functioning as measured by the North American Adult Reading Test (NAART)
時間枠：Baseline
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Baseline
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Functional status measured by the Duke Older Americans Resources and Services (OARS) Activities of Daily Living Scale
時間枠：Baseline, at each scheduled treatment visit, and at 3 months post-treatment
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Baseline, at each scheduled treatment visit, and at 3 months post-treatment
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Symptom prevalence and distress measured using the short form of the Memorial Symptom Assessment Scale (MSASSF)
時間枠：Baseline, at each scheduled treatment visit, and at 3 months post-treatment
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Baseline, at each scheduled treatment visit, and at 3 months post-treatment
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Mood State measured by the Profile of Mood States (POMS-SF)
時間枠：Baseline, at each scheduled treatment visit, and at 3 months post-treatment
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Baseline, at each scheduled treatment visit, and at 3 months post-treatment
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Overall quality of life measured using Cantril's Ladder
時間枠：Baseline and 3 months post-treatment
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Baseline and 3 months post-treatment
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Coping measured by the Mini-Mental Adjustment to Cancer Scale (Mini-MAC)
時間枠：Baseline and 3 months post-treatment
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Baseline and 3 months post-treatment
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Hospitalizations, emergency department visits, and unscheduled clinic visits
時間枠：At each scheduled treatment visit and 3 months post-treatment
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At each scheduled treatment visit and 3 months post-treatment
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Falls, injuries, and other complications
時間枠：At each scheduled treatment visit and 3 months post-treatment
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At each scheduled treatment visit and 3 months post-treatment
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協力者と研究者
捜査官
- スタディチェア：Stewart M. Bond, PhD, RN、Vanderbilt-Ingram Cancer Center
研究記録日
主要日程の研究
研究開始
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
キーワード
追加の関連 MeSH 用語
その他の研究ID番号
- CDR0000565963
- P30CA068485 (米国 NIH グラント/契約)
- VU-VICC-SUPP-0751
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。
せん妄の臨床試験
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Bozok University募集術後合併症 | 小児患者 | 術前不安（Ameliyat Öncesi Anksiyete） | Emergence Delirium (覚醒時せん妄)トルコ（Türkiye）
Assessment of therapy complicationsの臨床試験
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Vyaire Medicalまだ募集していません
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Massachusetts General HospitalPatient-Centered Outcomes Research Institute; Dartmouth-Hitchcock Medical Center; Griffin Hospital と他の協力者募集