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.
연구 개요
상태
상세 설명
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.
연구 유형
등록 (실제)
연락처 및 위치
연구 장소
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Tennessee
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Nashville, Tennessee, 미국, 37208
- MBCCOP - Meharry Medical College - Nashville
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Nashville, Tennessee, 미국, 37232-6838
- Vanderbilt-Ingram Cancer Center
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Nashville, Tennessee, 미국, 37064
- Vanderbilt-Ingram Cancer Center - Cool Springs
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Nashville, Tennessee, 미국, 37064
- Vanderbilt-Ingram Cancer Center at Franklin
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
개입 / 치료 |
|---|---|
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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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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
|---|---|
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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
기간: 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)
기간: 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
기간: 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)
기간: 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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2차 결과 측정
결과 측정 |
기간 |
|---|---|
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Alcohol, tobacco, and drug use as measured by the Alcohol Use Disorders Identification Test (AUDIT)
기간: Baseline
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Baseline
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Premorbid intellectual functioning as measured by the North American Adult Reading Test (NAART)
기간: 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
기간: 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)
기간: 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)
기간: 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
기간: 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)
기간: 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
기간: 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
기간: 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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공동 작업자 및 조사자
수사관
- 연구 의자: Stewart M. Bond, PhD, RN, Vanderbilt-Ingram Cancer Center
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
키워드
추가 관련 MeSH 약관
기타 연구 ID 번호
- CDR0000565963
- P30CA068485 (미국 NIH 보조금/계약)
- VU-VICC-SUPP-0751
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