- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg 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?
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
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Etlik
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Ankara, Etlik, Tyrkiet (Türkiye), 06010
- Health Sciences University Gulhane Training and Research Hospital
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Støttende pleje
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Ingen indgriben: 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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Eksperimentel: 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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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Change in Cognitive Function (Standardized Mini-Mental Test)
Tidsramme: 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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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Change in Subjective Cognitive Function (Functional Assessment of Cancer Therapy - Cognitive Function)
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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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Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: Gizem Erdoğan, Hemşire, Health Sciences University Gulhane Training and Research Hospital
- Studieleder: Betülay Kılıç, Doçent Doktor, Health Sciences University Gulhane Faculty of Nursing
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
- Psykiske lidelser
- Neoplasmer efter sted
- Neoplasmer
- Adfærdsmæssige symptomer
- Neurokognitive lidelser
- Kognitionsforstyrrelser
- Kemisk inducerede lidelser
- Hudsygdomme
- Brystsygdomme
- Lægemiddelrelaterede bivirkninger og uønskede reaktioner
- Kognitiv dysfunktion
- Opførsel
- Hud- og bindevævssygdomme
- Kemoterapi-relateret kognitiv svækkelse
- Depression
- Brystneoplasmer
Andre undersøgelses-id-numre
- Decision No. 2025/23
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
IPD-planbeskrivelse
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
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