The Effect of Education Brain Tumors (Education&BT)
The Effect of the Education for Brain Tumor Patients and Their Caregivers on the Quality of Life and Care Burden
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Patients with brain tumors often face physical, cognitive, emotional, and behavioral challenges that negatively impact their quality of life (Townsley, 2014). A review of the literature indicates that, unlike patients with other types of cancer, brain tumor patients' greater dependence on others for daily activities causes stress for caregivers, increases the burden of care, and reduces caregivers' quality of life (Özdingiş, 2020; Maşalacı, 2017; Schubart et al., 2007; Olver et al., 2020; Cashman et al., 2019).
Previous studies have noted that nursing interventions for patients with primary brain tumors are limited; however, it has been observed that such interventions improve patients' cognitive and emotional well-being and reduce the care burden on caregivers (Halkett et al. 2018; Langbecker and Janda, 2015; Tokunaga et al., 2024). A review of the national literature on education and counseling provided by nurses to patients revealed a limited number of studies, which emphasized the need to also provide education to family members during the disease adaptation process (Baksi Şimşek, 2013). It is anticipated that the results of this study will contribute to nursing practices and research.
Hypotheses:
H1: The quality of life of patients with primary brain tumors who receive structured education is higher than that of patients who receive routine/standard education.
H2: The severity of symptoms in patients with primary brain tumors who receive structured education is lower than that of patients who receive routine/standard education.
H3: The quality of life of caregivers for patients with primary brain tumors who receive structured education is higher than that of caregivers for patients who receive routine/standard education.
H4: The burden of care for caregivers of patients with primary brain tumors who receive structured education is lower than that of caregivers for patients who receive routine/standard education.
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Merve Nur Demiryürek, MSc Student
- Número de teléfono: +90 534 065 73 48
- Correo electrónico: mervenurdemir16@gmail.com
Copia de seguridad de contactos de estudio
- Nombre: Aylin Özakgül, Mrs.
- Número de teléfono: +90 532 065 51 70
- Correo electrónico: aylin.ozakgul@iuc.edu.tr
Ubicaciones de estudio
-
-
Istanbul
-
Istanbul, Istanbul, Turquía (Türkiye), 34480
- Reclutamiento
- Istanbul Basaksehir Cam and Sakura City Hospital
-
Investigador principal:
- Merve Nur Demiryürek, MSc Student
-
Contacto:
- Merve Nur N Demiryürek, MSc Student
- Número de teléfono: +90 534 065 73 48
- Correo electrónico: mervenurdemir16@gmail.com
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria
For Patients
- Aged >18 years
- Undergoing primary brain tumor surgery for the first time
- Glasgow Coma Scale score of 15
- Able to assess and express symptoms
- Literate in Turkish
- No psychiatric history
- Not using psychiatric medication
- Willing to participate and provide consent
For Caregivers
- Aged >18 years
- Primary caregiver providing care for at least 3 months
- Open to communication and cooperation
- No psychiatric history
- Not using psychiatric medication
- Willing to participate and provide consent
Exclusion Criteria
- Not meeting the inclusion criteria
- Intubated patients
- Patients with metastatic brain tumors
- Patients with pituitary tumors
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Cuidados de apoyo
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: Experimental: Intervention Group
Patients and caregivers in the experimental group will receive preoperative education structured according to the Nursing Life Model, which was developed based on the literature.The Roper-Logan-Tierney Nursing Model of Living is one of the most widely utilized frameworks in nursing practice.
The primary aim of the model is to guide nurses in providing care through the assessment of an individual's activities of living.
|
Patients and caregivers in the experimental group will receive preoperative education structured according to the Nursing Life Model, which was developed based on the literature.The Roper-Logan-Tierney Nursing Model of Living is one of the most widely utilized frameworks in nursing practice.
The primary aim of the model is to guide nurses in providing care through the assessment of an individual's activities of living.
|
|
Sin intervención: No Intervention: Control Group
Patients and caregivers in this group will not receive any education other than the routine discharge training routinely provided in the clinic.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Patient's and caregiver quality of life
Periodo de tiempo: before surgery, on the day 1 of discharge and 1 month after discharge
|
Quality of life will be assessed using the validated quality of life scales SF-12 and EQ-5D-5L.
Assessments will be conducted preoperatively with SF-12 and EQ-5D-5L; on the day of discharge with EQ-5D-5L; and one month after discharge with SF-12 and EQ-5D-5L.
|
before surgery, on the day 1 of discharge and 1 month after discharge
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Caregivers caregiver Burden
Periodo de tiempo: The patient will be evaluated before surgery, on the day 1 of discharge, and one month after discharge.
|
To assess changes following the training intervention, the caregiver's burden will be evaluated using the validated Caregiver Burden Scale.The scale, which can be completed either by the caregiver themselves or through an interviewer, consists of 22 items that determine the impact of caregiving on the caregiver's life. It uses a Likert-type response format ranging from 0 to 4, with options including never, rarely, sometimes, often, and nearly always. Studies have reported internal consistency reliability coefficients between 0.87 and 0.94, and test-retest reliability of 0.71. Scores on the scale range from 0 to 88, with higher scores indicating a greater level of burden experienced. The Turkish validity and reliability study was conducted by Erdem and İnci in 2008, with reliability coefficients between 0.71 and 0.86, demonstrating high reliability. |
The patient will be evaluated before surgery, on the day 1 of discharge, and one month after discharge.
|
|
Symptom burden
Periodo de tiempo: Measurements will be taken before surgery, on the day 1 of discharge, and one month after discharge.
|
Symptom burden will be assessed using the MD Anderson Symptom Inventory - Brain Tumor Module.
This validated tool measures the severity of brain tumor-related symptoms and their interference with daily activities.
The inventory was developed by Armstrong et al., and all validity and reliability analyses were completed in 2006, with a total internal consistency reliability coefficient (Cronbach's alpha) of .91.
The MDA-BT consists of two sections, seven subscales, and a total of 28 items, each rated individually on a Likert-type scale ranging from 0 to 10.
The validity and reliability of the inventory for the Turkish population were established by Baksi and Dicle, yielding a Cronbach's alpha coefficient of .90.
|
Measurements will be taken before surgery, on the day 1 of discharge, and one month after discharge.
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Merve Nur N Demiryürek, Istanbul University- Cerrahpasa Institute of Graduate Studies
Publicaciones y enlaces útiles
Publicaciones Generales
- Baksi Şimşek, A. (2013). An Examination of Adaptive and Maladaptive Behaviours in Patients with Primary Brain Tumours Using the Roy Adaptation Model, and the Effect of Education on Symptoms and Coping, PhD Thesis. Dokuz Eylül University Institute of Health Sciences.
- Tokunaga R, Sakaki M, Kashiwa S, Hayashi N. Rehabilitation nursing for brain tumor patients: a scoping review. BMC Med Educ. 2025 Jun 2;25(1):821. doi: 10.1186/s12909-025-07423-0.
- Langbecker D, Janda M. Systematic review of interventions to improve the provision of information for adults with primary brain tumors and their caregivers. Front Oncol. 2015 Jan 23;5:1. doi: 10.3389/fonc.2015.00001. eCollection 2015.
- Halkett GKB, Lobb EA, Miller L, Shaw T, Moorin R, Long A, King A, Clarke J, Fewster S, Nowak AK. Feasibility Testing and Refinement of a Supportive Educational Intervention for Carers of Patients with High-Grade Glioma - a Pilot Study. J Cancer Educ. 2018 Oct;33(5):967-975. doi: 10.1007/s13187-017-1175-x.
- Philip J, Collins A, Staker J, Murphy M. I-CoPE: A pilot study of structured supportive care delivery to people with newly diagnosed high-grade glioma and their carers. Neurooncol Pract. 2019 Jan;6(1):61-70. doi: 10.1093/nop/npy010. Epub 2018 May 19.
- Olver I, Keefe D, Herrstedt J, Warr D, Roila F, Ripamonti CI. Supportive care in cancer-a MASCC perspective. Support Care Cancer. 2020 Aug;28(8):3467-3475. doi: 10.1007/s00520-020-05447-4. Epub 2020 Apr 27.
- Maşalacı, E (2017). Symptom Assessment in Patients with Primary Brain Tumors, Master's Thesis. Gazi University Institute of Health Sciences, Ankara.
- Özdingiş, Ş.Ö. (2020). An Investigation of Factors Affecting Quality of Life in Patients with Brain Tumors Presenting to a Foundation University Hospital, Master's Thesis. Yeditepe University Institute of Health Sciences, Istanbul.
- Townsley, E. (2014). Evidence-Based Practice in Neurological Nursing. Translated by H. Kaya. Nobel Medical Publishers, Istanbul, 331-332
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
- Enfermedades Cerebrales
- Enfermedades del Sistema Nervioso Central
- Enfermedades del Sistema Nervioso
- Neoplasias por sitio
- Neoplasias
- Neoplasias del Sistema Nervioso
- Neoplasias del Sistema Nervioso Central
- Neoplasias Cerebrales
- Práctica profesional
- Organización y administración
- Administración de Servicios de Salud
- Enfermería
Otros números de identificación del estudio
- E-96317027-514.10-286508325 (Otro identificador: Istanbul University- Cerrahpasa)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
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. .