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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 oppdatert av: 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.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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

Observasjonsmessig

Registrering (Faktiske)

86

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

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

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

21 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Prøvetakingsmetode

Ikke-sannsynlighetsprøve

Studiepopulasjon

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

Beskrivelse

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

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

Kohorter og intervensjoner

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

Hva måler studien?

Primære resultatmål

Resultatmål
Tidsramme
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
Tidsramme: Baseline and 3 months post-treatment
Baseline and 3 months post-treatment
Global neurocognitive functioning as measured by the Mini-Mental State Examination (MMSE)
Tidsramme: 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
Tidsramme: 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)
Tidsramme: Baseline, at each scheduled treatment visit, and at 3 months post-treatment
Baseline, at each scheduled treatment visit, and at 3 months post-treatment

Sekundære resultatmål

Resultatmål
Tidsramme
Alcohol, tobacco, and drug use as measured by the Alcohol Use Disorders Identification Test (AUDIT)
Tidsramme: Baseline
Baseline
Premorbid intellectual functioning as measured by the North American Adult Reading Test (NAART)
Tidsramme: Baseline
Baseline
Functional status measured by the Duke Older Americans Resources and Services (OARS) Activities of Daily Living Scale
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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
Tidsramme: Baseline and 3 months post-treatment
Baseline and 3 months post-treatment
Coping measured by the Mini-Mental Adjustment to Cancer Scale (Mini-MAC)
Tidsramme: Baseline and 3 months post-treatment
Baseline and 3 months post-treatment
Hospitalizations, emergency department visits, and unscheduled clinic visits
Tidsramme: 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
Tidsramme: At each scheduled treatment visit and 3 months post-treatment
At each scheduled treatment visit and 3 months post-treatment

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Vanderbilt University Medical Center

Samarbeidspartnere

National Cancer Institute (NCI)

Etterforskere

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

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. oktober 2007

Primær fullføring (Faktiske)

1. mai 2010

Studiet fullført (Faktiske)

1. juni 2013

Datoer for studieregistrering

Først innsendt

20. september 2007

Først innsendt som oppfylte QC-kriteriene

20. september 2007

Først lagt ut (Anslag)

24. september 2007

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

7. april 2017

Siste oppdatering sendt inn som oppfylte QC-kriteriene

5. april 2017

Sist bekreftet

1. april 2017

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • CDR0000565963
  • P30CA068485 (U.S. NIH-stipend/kontrakt)
  • VU-VICC-SUPP-0751

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