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Neurocognitive Functioning in Patients With Newly Diagnosed Upper Aerodigestive Tract Cancer Receiving Treatment at Henry-Joyce Cancer Clinic

5 april 2017 bijgewerkt door: Vanderbilt University Medical Center

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.

Studie Overzicht

Toestand

Voltooid

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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.

Studietype

Observationeel

Inschrijving (Werkelijk)

86

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

  • Verenigde Staten
    • Tennessee
      • Nashville, Tennessee, Verenigde Staten, 37208
        • MBCCOP - Meharry Medical College - Nashville
      • Nashville, Tennessee, Verenigde Staten, 37232-6838
        • Vanderbilt-Ingram Cancer Center
      • Nashville, Tennessee, Verenigde Staten, 37064
        • Vanderbilt-Ingram Cancer Center - Cool Springs
      • Nashville, Tennessee, Verenigde Staten, 37064
        • Vanderbilt-Ingram Cancer Center at Franklin

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

21 jaar en ouder (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Bemonsteringsmethode

Niet-waarschijnlijkheidssteekproef

Studie Bevolking

Patients with newly diagnosed upper aerodigestive system cancers (head and neck, lung, and esophagus)

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

Cohorten en interventies

Groep / Cohort
Interventie / Behandeling
Treatment
Patients undergoing treatment for head and neck, lung, and esophagus cancers
Ander: Assessment of therapy complications
Assessment of neurocognitive function, functional status, symptom prevalence and distress, and mood alterations
Ander: Neurocognitive assessment
Assessment of neurocognitive domains: attention/concentration, executive function, verbal learning, verbal memory, verbal fluency
Ander: Quality-of-life assessment
Assessment of quality of life using Cantrill's Ladder at baseline and 3 months post-treatment

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Tijdsspanne
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
Tijdsspanne: Baseline and 3 months post-treatment
Baseline and 3 months post-treatment
Global neurocognitive functioning as measured by the Mini-Mental State Examination (MMSE)
Tijdsspanne: Baseline, at each scheduled treatment visit, and at 3 months post-treatment
Baseline, at each scheduled treatment visit, and at 3 months post-treatment
Self-reported neurocognitive symptoms as measured by the Alertness Behavior Subscale of the Sickness Impact Profile
Tijdsspanne: Baseline, at each scheduled treatment visit, and at 3 months post-treatment
Baseline, at each scheduled treatment visit, and at 3 months post-treatment
Delirium and delirium symptoms by the NEECHAM Confusion Scale and Confusion Assessment Method (CAM)
Tijdsspanne: Baseline, at each scheduled treatment visit, and at 3 months post-treatment
Baseline, at each scheduled treatment visit, and at 3 months post-treatment

Secundaire uitkomstmaten

Uitkomstmaat
Tijdsspanne
Alcohol, tobacco, and drug use as measured by the Alcohol Use Disorders Identification Test (AUDIT)
Tijdsspanne: Baseline
Baseline
Premorbid intellectual functioning as measured by the North American Adult Reading Test (NAART)
Tijdsspanne: Baseline
Baseline
Functional status measured by the Duke Older Americans Resources and Services (OARS) Activities of Daily Living Scale
Tijdsspanne: Baseline, at each scheduled treatment visit, and at 3 months post-treatment
Baseline, at each scheduled treatment visit, and at 3 months post-treatment
Symptom prevalence and distress measured using the short form of the Memorial Symptom Assessment Scale (MSASSF)
Tijdsspanne: Baseline, at each scheduled treatment visit, and at 3 months post-treatment
Baseline, at each scheduled treatment visit, and at 3 months post-treatment
Mood State measured by the Profile of Mood States (POMS-SF)
Tijdsspanne: Baseline, at each scheduled treatment visit, and at 3 months post-treatment
Baseline, at each scheduled treatment visit, and at 3 months post-treatment
Overall quality of life measured using Cantril's Ladder
Tijdsspanne: Baseline and 3 months post-treatment
Baseline and 3 months post-treatment
Coping measured by the Mini-Mental Adjustment to Cancer Scale (Mini-MAC)
Tijdsspanne: Baseline and 3 months post-treatment
Baseline and 3 months post-treatment
Hospitalizations, emergency department visits, and unscheduled clinic visits
Tijdsspanne: At each scheduled treatment visit and 3 months post-treatment
At each scheduled treatment visit and 3 months post-treatment
Falls, injuries, and other complications
Tijdsspanne: At each scheduled treatment visit and 3 months post-treatment
At each scheduled treatment visit and 3 months post-treatment

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Vanderbilt University Medical Center

Medewerkers

National Cancer Institute (NCI)

Onderzoekers

  • Studie stoel: Stewart M. Bond, PhD, RN, Vanderbilt-Ingram Cancer Center

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start

1 oktober 2007

Primaire voltooiing (Werkelijk)

1 mei 2010

Studie voltooiing (Werkelijk)

1 juni 2013

Studieregistratiedata

Eerst ingediend

20 september 2007

Eerst ingediend dat voldeed aan de QC-criteria

20 september 2007

Eerst geplaatst (Schatting)

24 september 2007

Updates van studierecords

Laatste update geplaatst (Werkelijk)

7 april 2017

Laatste update ingediend die voldeed aan QC-criteria

5 april 2017

Laatst geverifieerd

1 april 2017

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • CDR0000565963
  • P30CA068485 (Subsidie/contract van de Amerikaanse NIH)
  • VU-VICC-SUPP-0751

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