Un estudio de pruebas y cuestionarios neurocognitivos para personas con cáncer de cabeza y cuello que se someten a radioterapia
Estudio piloto de la función neurocognitiva asociada a la radiación entre pacientes con cáncer de cabeza y cuello
The researchers are doing this study to collect more information about if, and how, neurocognitive function may be affected in people being treated with radiation therapy for head and neck cancer. Part of this study is to see if patients diagnosed with head and neck cancer who are undergoing radiation therapy are able to complete neurocognitive testing and questionnaires at 3 times over a period of 1 year.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Estimado)
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Jonine Bernstein, PhD
- Número de teléfono: 646-888-8241
- Correo electrónico: bernstej@mskcc.org
Copia de seguridad de contactos de estudio
- Nombre: Lawrence Dauer, PhD
- Número de teléfono: 212-639-5372
Ubicaciones de estudio
-
-
New Jersey
-
Basking Ridge, New Jersey, Estados Unidos, 07920
- Reclutamiento
- Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)
-
Contacto:
- Jonine Bernstein, PhD
- Número de teléfono: 646-888-8241
-
Middletown, New Jersey, Estados Unidos, 07748
- Reclutamiento
- Memorial Sloan Kettering Monmouth (Limited Protocol Activities)
-
Contacto:
- Jonine Bernstein, MD
- Número de teléfono: 646-888-8241
-
Montvale, New Jersey, Estados Unidos, 07645
- Reclutamiento
- Memorial Sloan Kettering Bergen (Limited Protocol Activities)
-
Contacto:
- Jonine Bernstein, PhD
- Número de teléfono: 646-888-8241
-
-
New York
-
Commack, New York, Estados Unidos, 11725
- Reclutamiento
- Memorial Sloan Kettering Suffolk- Commack (Limited Protocol Activities)
-
Contacto:
- Jonine Bernstein, PhD
- Número de teléfono: 646-888-8241
-
Harrison, New York, Estados Unidos, 10604
- Reclutamiento
- Memorial Sloan Kettering Westchester (Limited Protocol Activities)
-
Contacto:
- Jonine Bernstein, PhD
- Número de teléfono: 646-888-8241
-
New York, New York, Estados Unidos, 10065
- Reclutamiento
- Memorial Sloan Kettering Cancer Center (All Protocol Activities)
-
Contacto:
- Jonine Bernstein, PhD
- Número de teléfono: 646-888-8241
-
Investigador principal:
- Jonine Bernstein, PhD
-
Contacto:
- Lawrence Dauer, PhD
- Número de teléfono: 212-639-5372
-
Rockville Centre, New York, Estados Unidos, 11553
- Reclutamiento
- Memorial Sloan Kettering Nassau (Limited Protocol Activities)
-
Contacto:
- Jonine Bernstein, PhD
- Número de teléfono: 646-888-8241
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
MSK patients at any location, diagnosed with HNC (nasopharynx, maxillary sinus, tonsil, base of the tongue, oral cavity, and larynx/hypopharynx).
Descripción
Inclusion Criteria:
-
Pathologically proven diagnosis of a head and neck cancer, specifically these subtypes: nasopharynx, maxillary sinus, tonsil, base of the tongue, oral cavity, or larynx/hypopharynx, oropharynx, cancer of unknown primary, or salivary gland.
-
Ages ≥ 18 and <89 at time of diagnosis.
-
Recently diagnosed with their initial head and neck cancer and able to be consented prior to OR within first week of starting standard of care radiation therapy.
-
Baseline simulation whole-brain MRI or CT available as part of standard of care.
-
Patients diagnosed with cancer, no distant metastases.
-
Karnofsky Performance Status of >= 70 or comparable ECOG performance at enrollment.
-
As per self-report, if currently taking psychoactive medications (excluding gabapentin and including but not limited to antidepressants, and anxiolytics) on a daily basis, dose must have been stable for at least two months prior to enrollment.
-
English fluent as per self-reported fluency of "well' or "very well", and having a reasonable comprehension of the study conversation in the opinion of the research staff).** ** Language verification: Prior to enrollment, all patients will be asked the following two questions by the CRC to verify English fluency necessary for participation in the study:
-
How well do you speak English?
Must respond "Well" or "Very well" when given the choices of:
Very well, Well, Not well, Not at all, Don't know, or Refused.
-
What is your preferred language for healthcare? Must respond English.
-
Exclusion Criteria:
- Patients with multiple primary head and neck cancers, carcinoma of unknown primary, or recurrence.
- Patients who previously received radiation therapy to the head and neck region as treatment for any prior cancer for any other non-cancerous condition.
- Patients who had chemotherapy within two years prior to their recent diagnosis of head and neck cancer, such as patients who received chemotherapy as treatment for any other type of cancer or received neoadjuvant chemotherapy prior to surgery to treat their recent head and neck diagnosis. Patients who receive induction chemotherapy just prior to the start of their radiation therapy or receive concurrent chemotherapy to treat their recent head and neck diagnosis are allowed
- At the discretion of the clinician, patients who are unable to comfortably speak due to symptoms of their cancer or treatment, such as surgery.
- Pre-existing diagnosis of neurodegenerative disorder that affects cognitive function (e.g. Alzheimer's disease, Parkinson's disease, Multiple Sclerosis, Dementia, Seizure Disorders, etc.).
- As per medical record or self-report, history of stroke or head injury requiring medical care, confirmed structural lesion on neuroimaging, and persistent cognitive difficulties impacting work or daily life or required cognitive rehabilitation.
- Pre-existing diagnosis of a Schizophrenia Spectrum Disorder, substance use disorder, Bipolar Disorder or Schizotypal personality disorder. Schizophrenia Spectrum Disorders include Schizophrenia, Schizophreniform disorder, Schizoaffective disorder, Delusional disorder, Brief psychotic disorder, and Attenuated Psychotic Disorder.
- Pre-existing visual or auditory impairment that would preclude ability to complete the assessments (e.g. history of significant macular degeneration or being unable to correct hearing with hearing aids)
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Modelos observacionales: COHORT
- Perspectivas temporales: PROSPECTIVE
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
|---|---|
|
Phase I: Neurocognitive Tests and Questionnaires
The performance-based measures will be administered with a total completion time estimated to be 90 minutes. The neurocognitive battery is similar in content and duration to multiple previous and ongoing studies being conducted by the Neurocognitive Research Lab. |
Baseline only: WRAT Reading Test, WMS-IV Logical Memory Subtest, Hopkins Verbal Learning Test (HVLT), Oral Trailmaking - Part A and B, NAB Digit Span, Category Fluency Test, Oral Symbol Digit Modalities Test, Brief Test of Attention, FAS - Controlled Oral Word Association Test (COWAT), Verbal Naming, Enformia Cogsuite Battery Sociodemographics, Computerized Cognitive Training Programs Questionnaire, CDC Behavioral Risk Factor (Smoking Assessment), Alcohol Consumption CDC, Current Health Rating (KPS), OARS Physical Health section, COVID Medical History, Hospital Anxiety and Depression Scale (HADS), Fatigue Symptom Inventory (FSI), Functional Assessment of Cancer Therapy-General (FACT-G V4), Functional Assessment of Cancer Therapy-Cognition (FACT-Cog V3), Sensory Gating Inventory (SGI) |
|
Phase II: Neurocognitive Tests and Questionnaires
The performance-based measures will be administered with a total completion time estimated to be 90 minutes. The neurocognitive battery is similar in content and duration to multiple previous and ongoing studies being conducted by the Neurocognitive Research Lab. |
Baseline only: WRAT Reading Test, WMS-IV Logical Memory Subtest, Hopkins Verbal Learning Test (HVLT), Oral Trailmaking - Part A and B, NAB Digit Span, Category Fluency Test, Oral Symbol Digit Modalities Test, Brief Test of Attention, FAS - Controlled Oral Word Association Test (COWAT), Verbal Naming, Enformia Cogsuite Battery Sociodemographics, Computerized Cognitive Training Programs Questionnaire, CDC Behavioral Risk Factor (Smoking Assessment), Alcohol Consumption CDC, Current Health Rating (KPS), OARS Physical Health section, COVID Medical History, Hospital Anxiety and Depression Scale (HADS), Fatigue Symptom Inventory (FSI), Functional Assessment of Cancer Therapy-General (FACT-G V4), Functional Assessment of Cancer Therapy-Cognition (FACT-Cog V3), Sensory Gating Inventory (SGI) |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Number of newly diagnosed head and neck cancer patients recruited and retained on study
Periodo de tiempo: 1 year
|
have complete the neurocognitive testing |
1 year
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Jonine Bernstein, PhD, Memorial Sloan Kettering Cancer Center
Publicaciones y enlaces útiles
Enlaces Útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Neoplasias por sitio
- Neoplasias
- Neoplasias de Cabeza y Cuello
- Calidad, acceso y evaluación de la atención médica
- Técnicas de investigación
- Métodos epidemiológicos
- Recopilación de datos
- Mecanismos de evaluación de atención médica
- Calidad de la atención médica
- Salud pública
- Medio ambiente y salud pública
- Disciplinas y actividades de comportamiento
- Pruebas psicológicas
- Pruebas neuropsicológicas
- Encuestas y cuestionarios
- Estado mental y pruebas de demencia
Otros números de identificación del estudio
- 21-498
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .