- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07570251
Evaluation of Cognitive Education Activities in Breast Cancer Patients Receiving Chemotherapy
Evaluation of Cognitive Education Activities Provided to Breast Cancer Patients Receiving Chemotherapy
Breast cancer is one of the most common cancer types worldwide and accounts for approximately 31% of all cancers in women. The global incidence of breast cancer is increasing, making it a significant public health problem. Advances in breast cancer management, including surgery, chemotherapy, radiotherapy, and hormone therapy, have contributed to reduced mortality rates. However, despite these positive developments, chemotherapy-related cognitive impairment, commonly referred to as "chemobrain," may occur.
Chemotherapy-induced cognitive impairment may manifest as deficits in memory, learning, attention, motor functions, executive functions, visual-spatial abilities, and information processing speed. These impairments negatively affect patients' quality of life and daily functioning.
In this study, cognitive education activities were designed and implemented to address these impairments. These activities aimed to support attention, memory, and executive functions and to minimize cognitive deficits. The purpose of this study was to examine the effects of cognitive activities applied to breast cancer patients receiving chemotherapy on cognitive functions, depression levels, and odor recognition abilities.
The study sought to answer the following research questions:
- What is the effect of cognitive education activities on odor recognition ability in breast cancer patients receiving chemotherapy?
- What is the effect of cognitive education activities on cognitive functions in breast cancer patients receiving chemotherapy?
- What is the effect of cognitive education activities on depression levels in these patients?
Descripción general del estudio
Estado
Intervención / Tratamiento
Descripción detallada
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Etlik
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Ankara, Etlik, Turquía (Türkiye), 06010
- Health Sciences University Gulhane Training and Research Hospital
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria:
Participants were eligible if they met all of the following criteria:
- Aged between 18 and 65 years
- Literate
- Diagnosed with breast cancer
- Had received at least one cycle of chemotherapy and were currently undergoing chemotherapy
- Had a Standardized Mini-Mental Test (SMMT) score of 24 or below
- Had no diagnosed cognitive, neurological, or psychiatric disorder prior to chemotherapy
Exclusion Criteria:
Participants were excluded if they met any of the following criteria:
- Age over 65 years
- SMMT score above 24
- Presence of brain metastases
- Presence of neurological or medical conditions affecting cognitive function
- Diagnosed psychiatric disorder
- Current use of central nervous system depressants, stimulants, or psychiatric medications
- History of alcohol or substance abuse
Withdrawal Criteria:
Participants were withdrawn from the study if any of the following occurred:
- Discontinuation of chemotherapy treatment
- Inability to attend follow-up visits regularly
- Failure to complete the cognitive activity booklet tasks
- Loss of contact or inability to reach the participant
- Voluntary withdrawal from the study
- Death during the study period
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Cuidados de apoyo
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Sin intervención: Control Group (Routine Care)
Participants in the control group received routine chemotherapy follow-up and standard care without any additional cognitive intervention during the study period.
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Experimental: Intervention Group (Cognitive Education)
Participants in the intervention group received structured cognitive function training activities in addition to routine care.
The intervention was delivered using printed activity booklets designed to support cognitive function.
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Participants received structured cognitive training through printed activity booklets designed to support attention, memory, executive functions, and language skills.
The booklets included activities such as puzzles, word derivation, sentence completion, pattern recognition, coloring, reading comprehension, and sudoku.
Four booklets with progressively increasing difficulty levels were provided over a 12-week period.
Each booklet was designed to be completed over three weeks.
The intervention was supported by face-to-face sessions and weekly telephone follow-ups to enhance adherence.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Change in Cognitive Function (Standardized Mini-Mental Test)
Periodo de tiempo: From baseline to the end of the 12-week intervention period
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Cognitive function was assessed using the Standardized Mini-Mental State Examination (SMMSE/SMMT).
The scale evaluates global cognitive status across domains including orientation, registration, attention and calculation, recall, and language.
Scores range from 0 to 30, where 30 represents maximum cognitive function and scores below 24 may indicate cognitive impairment.
Higher scores indicate better cognitive performance.
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From baseline to the end of the 12-week intervention period
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Change in Subjective Cognitive Function (Functional Assessment of Cancer Therapy - Cognitive Function)
Periodo de tiempo: From baseline to the end of the 12-week intervention period
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Subjective cognitive function was assessed using the Functional Assessment of Cancer Therapy - Cognitive Function (FACT-Cog) Version 3.
This self-report scale consists of 37 items categorised into four subscales: Perceived Cognitive Impairment, Comments from Others, Perceived Cognitive Abilities, and Impact of Cognitive Impairment on Quality of Life.
Each item is rated on a 5-point Likert scale (0=Not at all to 4=Very much), with higher total scores indicating better perceived cognitive health and fewer cognitive complaints.
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From baseline to the end of the 12-week intervention period
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Change in Depression Level (Beck Depression Inventory)
Periodo de tiempo: From baseline to the end of the 12-week intervention period
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Depression levels were assessed using the Beck Depression Inventory (BDI), a 21-item self-report scale evaluating the severity of depressive symptoms.
Total scores range from 0 to 63, with higher scores indicating more severe depressive symptoms.
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From baseline to the end of the 12-week intervention period
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Odor Recognition Ability
Periodo de tiempo: From baseline to the end of the 12-week intervention period
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Odor recognition ability was assessed using a structured odor identification test consisting of 8 common odors presented in opaque (non-transparent) containers.
Participants were asked to smell each container and indicate whether they could correctly recognize the odor.
The assessment was based on whether each odor was correctly identified or not, rather than a numerical scoring system.
The odors included familiar scents such as coffee, lavender, lemon, orange, onion, rose water, cinnamon, and mint.
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From baseline to the end of the 12-week intervention period
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Gizem Erdoğan, Hemşire, Health Sciences University Gulhane Training and Research Hospital
- Director de estudio: Betülay Kılıç, Doçent Doktor, Health Sciences University Gülhane Faculty of Nursing
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
- Desordenes mentales
- Neoplasias por sitio
- Neoplasias
- Síntomas de comportamiento
- Trastornos neurocognitivos
- Trastornos cognitivos
- Trastornos inducidos químicamente
- Enfermedades de la piel
- Enfermedades de los senos
- Efectos secundarios y reacciones adversas relacionados con los medicamentos
- Disfunción congnitiva
- Comportamiento
- Enfermedades de la piel y del tejido conectivo
- Deterioro cognitivo relacionado con la quimioterapia
- Depresión
- Neoplasias de mama
Otros números de identificación del estudio
- Decision No. 2025/23
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.
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