- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT03213431
Development of the Pediatric Neurocognitive Functioning Questionnaire
Assessing Patient-Reported Neurocognitive Functioning in Pediatric Oncology: A Pilot Study Toward Developing the Pediatric Neurocognitive Questionnaire (PNCQ)
This study will examine self-reported neurocognitive functioning in pediatric cancer survivors whose cancer therapy may have included cranial radiation, intrathecal chemotherapy, and high-dose intravenous antimetabolite chemotherapy. There is evidence that these therapies which are directed at the central nervous system (CNS) can lead to reduced volumes of normal-appearing white matter and neurocognitive dysfunction.
Neurocognitive deficits can significantly impact pediatric cancer survivors' academic success, daily functional status, and quality of life. Previous studies demonstrate the need for screening and treating neurocognitive dysfunction in childhood cancer patients and survivors.
This pilot study will conduct cognitive debriefing tests with childhood cancer survivors, 30 with and 10 without neurocognitive deficits, and their parents. The collected data will aid in developing a comprehensive patient-reported outcomes (PRO) toolkit consisting of generic and specific cognitive and behavioral domains that are content-appropriate and interface-friendly for pediatric cancer populations.
PRIMARY OBJECTIVE:
- To conduct cognitive debriefing tests with 30 pediatric cancer survivors who have global neurocognitive impairment (i.e., the impaired group) to understand the cognitive process of answering the extant pediatric PRO measures by different levels of general intelligence quotient (IQ). Additionally, 10 pediatric cancer survivors who have at least average general IQ (i.e., the unimpaired group) will be recruited for a comparison purpose.
SECONDARY OBJECTIVE:
- To conduct semi-structured interviews with 30 parents/legal guardians of individuals who have global cognitive impairment as described in the primary objective in order to explore the general concept of their child's neurocognitive functioning, to rank the relative importance of different neurocognitive functioning domains, to inform a strategy for communicating with children and adolescents with impaired neurocognitive functioning for PRO research, and to suggest a user-friendly interface to collect PRO data from cognitively impaired children and adolescents. Additionally, 10 parents/legal guardians of individuals at least average general IQ will be recruited for comparison.
Descripción general del estudio
Estado
Condiciones
Descripción detallada
Pediatric participants will undergo a 30-45 minute cognitive interview including three sections:
- Introduction to the study and warm-up debriefing exercise.
- Determination of participant's level of understanding by arranging circles of different sizes.
- Completion of individual surveys including the Child Health & Illness Profile-Child Edition/Child Report Form (CHIP-CE/CRF), the Applied Cognition scale of the Neuro-QOL, and the Pediatric Perceived Cognitive Function (PedPCF - Child).
For patient participants who have not had IQ testing within the prior 3 years, IQ testing may be repeated.
Semi-structured interviews will be conducted with parents/legal guardians of pediatric participants including:
- Open-ended questions to help researchers understand whether their child is able to complete the CHIP-CE/CRF, Applied Cognition scale of the Neuro-QOL, and the PedPCF - Child.
- Concerns they may have about cognitive functioning issues and its importance for their child. They will also be asked their thoughts on how to communicate and interact effectively with children and adolescents who have cognitive delays and their feedback about a user-friendly way to collect patient-reported health data.
- The pediatric participant responses will be compared with their parent/legal guardian responses to confirm the answers were accurate and to evaluate whether the child can recall appropriate information for a given time frame.
Interviews will be conducted primarily on the St. Jude campus, or via Skype video meeting as a secondary option.
Tipo de estudio
Inscripción (Actual)
Contactos y Ubicaciones
Ubicaciones de estudio
-
-
Tennessee
-
Memphis, Tennessee, Estados Unidos, 38105
- St. Jude Children's Research Hospital
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
Descripción
Inclusion Criteria:
- Cancer survivors who are off cancer therapies;
- Children/youth age 8-17.9 years and their parents/legal guardians (i.e. dyads);
- Impaired and unimpaired general IQs (IQ 40-89 for impaired and IQ ≥90 for unimpaired); AND
- English speaking participants.
Exclusion Criteria:
- Only the child/adolescent or the parent is able to participate (i.e. non-dyads);
- Severe/profound IQ deficits (IQ <40); AND
- Non-English speaking participants.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
---|
IQ of <90 and ≥40
Patient-Reported Outcomes (PRO) will be evaluated in a group of 30 childhood cancer survivors with global neurocognitive impairment classified by IQ of <90 and ≥40 and 30 of their parents.
|
IQ of ≥90
Patient-Reported Outcomes (PRO) will be evaluated in a group of 10 childhood cancer survivors with global neurocognitive unimpairment classified by IQ of ≥90 and 10 of their parents.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Number of participants who are capable of completing the survey
Periodo de tiempo: At completion of the survey, up to 6 months after study enrollment.
|
Capability will be defined as the number of participants who complete the survey based on comprehension for the content of survey items.
|
At completion of the survey, up to 6 months after study enrollment.
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: I-Chan Huang, PhD, St. Jude Children's Research Hospital
Publicaciones y enlaces útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
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
Otros números de identificación del estudio
- PNCQ-HPP22
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. .