Evaluation of Cognitive Education Activities in Breast Cancer Patients Receiving Chemotherapy

NCT07570251 | Completed

• 1 other identifier: Decision No. 2025/23
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Breast Cancer; Chemotherapy-related Cognitive Impairment

Keywords

breast cancer; chemotherapy; cognitive function; depression; Cognitive training; Olfactory function

Outcome Measures

Primary Outcomes (1)

• Change in Cognitive Function (Standardized Mini-Mental Test)

  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

Secondary Outcomes (3)

• Change in Subjective Cognitive Function (Functional Assessment of Cancer Therapy - Cognitive Function)

  From baseline to the end of the 12-week intervention period

• Change in Depression Level (Beck Depression Inventory)

  From baseline to the end of the 12-week intervention period

• Odor Recognition Ability

  From baseline to the end of the 12-week intervention period

Study Arms (2)

Control Group (Routine Care)

NO INTERVENTION

Participants in the control group received routine chemotherapy follow-up and standard care without any additional cognitive intervention during the study period.

Intervention Group (Cognitive Education)

EXPERIMENTAL

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.

Behavioral: Cognitive Function Training Activities

Interventions

Cognitive Function Training Activities BEHAVIORAL

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.

Intervention Group (Cognitive Education)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Saglik Bilimleri Universitesi: lead

Study Sites (1)

Health Sciences University Gulhane Training and Research Hospital

Ankara, Etlik, 06010, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Breast Neoplasms; Chemotherapy-Related Cognitive Impairment; Depression

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Drug-Related Side Effects and Adverse Reactions; Chemically-Induced Disorders; Cognitive Dysfunction; Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Study Officials

• Gizem Erdoğan, Hemşire

  Health Sciences University Gulhane Training and Research Hospital

  PRINCIPAL INVESTIGATOR

• Betülay Kılıç, Doçent Doktor

  Health Sciences University Gulhane Faculty of Nursing

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The randomization sequence was generated by an independent statistician using a computer-based randomization tool. Outcome assessors and data analysts were blinded to group allocation. Data were coded as Group A and Group B during analysis to ensure blinding, and group identities were revealed only after the completion of statistical analyses.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Nurse

Model Details: This study is a randomized controlled trial with a parallel-group design. Participants were randomly assigned to intervention and control groups. The intervention group received structured cognitive function activities prepared by the researcher, while the control group received routine care without any additional intervention. Outcomes were compared between groups over time.

Study Record Dates

• First Submitted: April 9, 2026
• First Posted: May 6, 2026
• Study Start: March 3, 2025
• Primary Completion: February 24, 2026
• Study Completion: March 2, 2026
• Last Updated: May 6, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)