Chemotherapy-related cognitive impairment is a prevalent and distressing condition among breast cancer survivors, adversely affecting memory, attention, and overall cognitive function, thereby diminishing quality of life. Emerging evidence suggests that multimodal interventions combining cognitive training and adapted physical exercise may mitigate these cognitive deficits and associated symptoms. This study aims to evaluate the efficacy of a 12-week structured intervention integrating cognitive training and supervised physical exercise in improving cognitive function, fatigue, sleep quality, psychological distress, and overall well-being in women with breast cancer. Furthermore, it seeks to determine the optimal timing for such interventions to maximize their effectiveness. A randomized controlled trial involving 220 participants will assess subjective and objective cognitive outcomes, brain activity, and physical performance. The findings from this research may contribute to the development of evidence-based rehabilitation strategies, enhancing cognitive health and quality of life in breast cancer patients.
Women aged 18 years or older who were diagnosed with stage 0 to IV breast cancer.
Women undergoing chemotherapy (at least two cycles) or having completed it at least six months earlier.
Cognitive impairment must be reported, with scores below 54 on the FACT-Cog scale
Women with significant neurological conditions.
Women with psychiatric conditions.
Women with contraindications for physical exercise.
Parallel
Cognitive training
Other interventionCombined Intervention of Cognitive Training and Supervised Physical Exercise
Psychoeducational therapy
Other interventionAccording to standard clinical practice
Subjetive Cognitive function
It will be assessed using subjective cognitive function measured by Functional Assessment of Cancer Therapy-Cognition (FACT-Cog) scale.
Objective Cognitive Function
It will be assessed with Near Infrared Spectroscopy (regional cerebral oxygen saturation).
Fatigue
It will be measured with the Fatigue Symptom Inventory (FSI), which assesses the frequency, severity, and perceived interference of fatigue in daily life over the past week
Sleep quality
It will be assessed using the Pittsburgh Sleep Quality Index (PSQI), a well-validated questionnaire that evaluates sleep across seven components, including latency, duration, efficiency, disturbances, and the use of sleep medications
Insomnia
It will be assessed using the Insomnia Severity Index (ISI). This validated questionnaire consists of seven items that evaluate difficulties with sleep onset, sleep maintenance, and early morning awakening, as well as satisfaction with sleep patterns, interference with daily functioning, perceived impairment, and distress caused by sleep problems
Psychological distress
Psychological distress will be assessed using the Hospital Anxiety and Depression Scale (HADS). The HADS consists of 14 items, each scored from 0 to 3, yielding subscale scores for anxiety (HADS-A) and depression (HADS-D) that each range from 0 to 21, with higher scores indicating greater psychological distress (worse outcome). The total score ranges from 0 to 42.
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