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

5 avril 2017 mis à jour par: 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.

Aperçu de l'étude

Statut

Complété

Les conditions

Intervention / Traitement

Description détaillée

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.

Type d'étude

Observationnel

Inscription (Réel)

86

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

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

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

21 ans et plus (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

Méthode d'échantillonnage

Échantillon non probabiliste

Population étudiée

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

La description

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

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

Cohortes et interventions

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

Que mesure l'étude ?

Principaux critères de jugement

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

Mesures de résultats secondaires

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

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Vanderbilt University Medical Center

Collaborateurs

National Cancer Institute (NCI)

Les enquêteurs

  • Chaise d'étude: Stewart M. Bond, PhD, RN, Vanderbilt-Ingram Cancer Center

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude

1 octobre 2007

Achèvement primaire (Réel)

1 mai 2010

Achèvement de l'étude (Réel)

1 juin 2013

Dates d'inscription aux études

Première soumission

20 septembre 2007

Première soumission répondant aux critères de contrôle qualité

20 septembre 2007

Première publication (Estimation)

24 septembre 2007

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

7 avril 2017

Dernière mise à jour soumise répondant aux critères de contrôle qualité

5 avril 2017

Dernière vérification

1 avril 2017

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • CDR0000565963
  • P30CA068485 (Subvention/contrat des NIH des États-Unis)
  • VU-VICC-SUPP-0751

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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