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Cognitive Remediation Therapy (CRT) for Adults Treated for Cancer (CaCRT)

18 de octubre de 2018 actualizado por: Yale University

Cognitive Remediation Therapy (CRT) for Adults Treated for Cancer: A Single-arm Proof of Concept Study.

This study is to determine the safety, feasibility and acceptability of an 8-week cognitive remediation training (CRT) in patients treated for cancer. The secondary objective of the study is to estimate the effect size of CRT in improving neurocognitive functioning and quality of life. This is a single-arm proof of concept study. Patients treated for cancer with persistent cognitive complaints will be recruited from the outpatient clinic of the VA Comprehensive Cancer Center, West Haven, CT, Yale Medicine, and greater New Haven community.The active treatment phase will be followed by an assessment at the conclusion of treatment to evaluate changes in cognitive function and quality of life. Participants will be invited back to participate in a final follow-up assessment 2 months later.

Descripción general del estudio

Estado

Terminado

Condiciones

Intervención / Tratamiento

Descripción detallada

Objectives:

The primary objective of this study is to determine the safety, feasibility and acceptability of an 8-week cognitive training intervention in patients treated for cancer. The secondary objective of the study is to estimate the effect size of CRT in improving neurocognitive functioning and quality of life for three different populations of cancer patients.

Research Design:

This is a single-arm proof of concept study with three cancer groups. Patients treated for cancer with persistent cognitive complaints will be recruited from the outpatient clinic of the VA Comprehensive Cancer Center, West Haven, CT, Yale Medicine, and greater New Haven community. We intend to enroll approximately 30 participants, with approximately 10 from each of the following cancer treatment types (1) participants who are at least six months from completion of adjuvant chemotherapy or chemoradiation and are in remission; (2) participants who are receiving long-term chemotherapy (6 months or longer) with a diagnosis of Stage IV cancer and with stable medical condition; (3) participants who are receiving long-term (6 months or longer) hormone therapy (androgen deprivation therapy or anti-estrogen therapy). Patients in this group who received chemotherapy will be eligible if they completed chemotherapy at least 6 months prior to enrolling. There will be an eight-week intervention period and a two-month follow-up assessment.

Methodology:

Participants will participate in a pre-assessment to establish eligibility, baseline cognitive function, and quality of life. This will be followed by participation in a cognitive remediation program (Brain HQ) for eight weeks during which all participants receive up to 16 hours of computerized cognitive training and 16 45-minute Bridging groups where they learn cognitive skills for daily living. The active treatment phase will be followed by an assessment at the conclusion of treatment to evaluate changes in cognitive function and quality of life. Participants will be invited back to participate in a final follow-up assessment 2 months later.

Tipo de estudio

Intervencionista

Inscripción (Actual)

12

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

  • Estados Unidos
    • Connecticut
      • West Haven, Connecticut, Estados Unidos, 06516
        • VA Connecticut Healthcare System

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

18 años y mayores (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

Inclusion Criteria:

1.Participants who:

  1. are at least six months from completion of adjuvant chemotherapy or chemoradiation and are in remission or;
  2. are receiving long-term chemotherapy (6 months or longer) with a diagnosis of Stage IV cancer and with stable medical conditions or;
  3. are receiving long-term (6 months or longer) hormone therapy (androgen deprivation therapy or anti-estrogen therapy). Patients in this group who received chemotherapy will be eligible if they completed chemotherapy at least 6 months prior to enrolling.

2. Subjective reports of cognitive decline. 3. Report that they are interested in seeking treatment to address their cognitive concerns.

4. Age 18 or older. 5. Fluency in English and a 6th grade or higher reading level.

Exclusion Criteria:

  1. Does not meet one of the three participant categories
  2. Unstable medical condition.
  3. History of, or current symptoms of, serious psychiatric disorder requiring antipsychotic medications or hospitalization.
  4. Current substance abuse disorder.
  5. History of, or current central nervous system (CNS) malignancies, CNS radiation, intrathecal chemotherapy, or CNS-involved surgery.
  6. Current IQ estimate less than 80.
  7. Unable to give written informed consent.

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: N / A
  • Modelo Intervencionista: Asignación de un solo grupo
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: Cognitive Remediation Therapy
Cognitive Remediation Training is comprised of 8 weeks of active cognitive training using Brain HQ auditory and visual training tasks. Training is twice per week for up to 2 hours. Also included is a Bridging Group at each training session. The Bridging group provides information about cognitive training and compensatory strategies to generalize the benefits of training to daily life.
Conductual: Cognitive Remediation Therapy
Brain HQ is a computer based cognitive training that uses hierarchical adaptive technology to provide challenging and demanding training that is not too frustrating or discouraging. Training includes auditory and visual sensory training, memory and executive function exercises. The Bridging group is based on similar training programs that focus on self-regulation training, problem focused cognitive behavior therapy and compensatory cognitive strategies.
Otros nombres:
  • Cognitive Remediation Training

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Self-report of daily cognitive function
Periodo de tiempo: 8 weeks
Self-reported cognitive function includes symptoms of perceived cognitive impairments, perceived cognitive abilities, and overall quality of life. These are aggregated into a classification of overall degree of impairment and disability
8 weeks

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Neurocognitive function
Periodo de tiempo: 8 weeks
Neurocognitive assessments using neurocognitive tests of attention, processing speed, executive function and memory changes from baseline. Results are aggregated into an overall score reflecting neurocognitive change from baseline.
8 weeks

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Yale University

Investigadores

  • Investigador principal: Morris D Bell, Ph.D., Yale University

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio

1 de enero de 2017

Finalización primaria (Actual)

1 de agosto de 2017

Finalización del estudio (Actual)

1 de septiembre de 2017

Fechas de registro del estudio

Enviado por primera vez

10 de enero de 2017

Primero enviado que cumplió con los criterios de control de calidad

12 de septiembre de 2017

Publicado por primera vez (Actual)

15 de septiembre de 2017

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

22 de octubre de 2018

Última actualización enviada que cumplió con los criterios de control de calidad

18 de octubre de 2018

Última verificación

1 de octubre de 2018

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • MIRB 02072 MB0018

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

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. .

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