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Evaluation of Cognitive Education Activities in Breast Cancer Patients Receiving Chemotherapy

29 aprile 2026 aggiornato da: Gizem Erdoğan, Saglik Bilimleri Universitesi

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:

  1. What is the effect of cognitive education activities on odor recognition ability in breast cancer patients receiving chemotherapy?
  2. What is the effect of cognitive education activities on cognitive functions in breast cancer patients receiving chemotherapy?
  3. What is the effect of cognitive education activities on depression levels in these patients?

Panoramica dello studio

Descrizione dettagliata

This randomized controlled trial was conducted between March 2025 and February 2026 at the oncology outpatient clinic and chemotherapy unit of Gulhane Training and Research Hospital. The study aimed to evaluate the effects of cognitive education activities on cognitive function, depression levels, and odor recognition ability in breast cancer patients receiving chemotherapy. A total of 120 patients who met the inclusion criteria were enrolled in the study. Eligible participants were between 18 and 65 years of age, literate, diagnosed with breast cancer, had received at least one cycle of chemotherapy, were continuing treatment, and had no diagnosed neurological or cognitive disorder before or during chemotherapy. In addition, participants had a Standardized Mini-Mental Test (SMMT) score of 24 or below. Participants were randomly assigned to intervention (n=60) and control (n=60) groups using a computer-generated randomization method. During the study, 12 participants withdrew for various reasons, and the study was completed with 108 participants (54 in each group). The study was designed as a single-blind, pre-test/post-test randomized controlled trial. The intervention group received structured cognitive education through printed booklets, face-to-face sessions, and weekly telephone counseling. The cognitive activity program was designed to stimulate attention, memory, executive functions, and language skills. Four cognitive activity booklets with progressively increasing difficulty levels were developed. Since chemotherapy sessions were scheduled every three weeks according to the hospital protocol, each booklet was structured to be completed over a three-week period. Face-to-face sessions were conducted every three weeks, resulting in a total of five sessions over a 12-week period. During these sessions, participants completed structured cognitive activities included in the activity booklets, such as sudoku, puzzles, sentence completion, pattern recognition, word derivation, coloring, and reading comprehension exercises, all of which were designed to support cognitive functions. Weekly telephone follow-ups were conducted to enhance adherence to the intervention. To assess olfactory function, odor identification tasks were performed using non-transparent containers. Familiar scents such as lavender, coffee, lemon, orange, onion, rose water, and cinnamon were used. The control group received routine care without any cognitive intervention during the study period. After completion of the study, the control group was also provided with cognitive activity training and the educational materials used in the intervention. Data were collected using a sociodemographic data form, an odor identification test, the Standardized Mini-Mental Test (SMMT), the Functional Assessment of Cancer Therapy - Cognitive Function (FACT-Cog) scale (Version 3), and the Beck Depression Inventory (BDI). Measurements were conducted at baseline and at 12 weeks following the initial assessment.

Tipo di studio

Interventistico

Iscrizione (Effettivo)

108

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

    • Etlik
      • Ankara, Etlik, Turchia (Türkiye), 06010
        • Health Sciences University Gulhane Training and Research Hospital

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Terapia di supporto
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Separare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Nessun intervento: 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.
Sperimentale: 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.
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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change in Cognitive Function (Standardized Mini-Mental Test)
Lasso di tempo: From baseline to the end of the 12-week intervention period
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.
From baseline to the end of the 12-week intervention period

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change in Subjective Cognitive Function (Functional Assessment of Cancer Therapy - Cognitive Function)
Lasso di tempo: From baseline to the end of the 12-week intervention period
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.
From baseline to the end of the 12-week intervention period
Change in Depression Level (Beck Depression Inventory)
Lasso di tempo: From baseline to the end of the 12-week intervention period
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.
From baseline to the end of the 12-week intervention period
Odor Recognition Ability
Lasso di tempo: From baseline to the end of the 12-week intervention period
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.
From baseline to the end of the 12-week intervention period

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Investigatori

  • Investigatore principale: Gizem Erdoğan, Hemşire, Health Sciences University Gulhane Training and Research Hospital
  • Direttore dello studio: Betülay Kılıç, Doçent Doktor, Health Sciences University Gulhane Faculty of Nursing

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

3 marzo 2025

Completamento primario (Effettivo)

24 febbraio 2026

Completamento dello studio (Effettivo)

2 marzo 2026

Date di iscrizione allo studio

Primo inviato

9 aprile 2026

Primo inviato che soddisfa i criteri di controllo qualità

29 aprile 2026

Primo Inserito (Effettivo)

6 maggio 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

6 maggio 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

29 aprile 2026

Ultimo verificato

1 aprile 2026

Maggiori informazioni

Termini relativi a questo studio

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Descrizione del piano IPD

Individual participant data will not be shared publicly. The data were collected as part of a single-center randomized controlled trial conducted for academic thesis purposes and will not be made available for external use.

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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