An interventional study of Cognitive training and Psychoeducational therapy in Breast Cancer, sponsored by Universidad de Extremadura. Not yet recruiting at 1 site in Spain. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-06-12.
Sponsored by Universidad de Extremadura · Not applicable, Interventional, and Treatment
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.
14,825 studies on the registry are indexed under Breast Neoplasms; 3,319 are open to participants now.
This study's planned enrollment of 220 is above the median of 72 across 10,896 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →Universidad de Extremadura is the lead sponsor of 39 studies on the registry; 3 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Al list two cycles of chemotherapy.
Other: Cognitive training
Al list six months after the completion of chemotherapy.
Other: Cognitive training
Al list two cycles of chemotherapy.
Other: Psychoeducational therapy
Al list six months after the completion of chemotherapy.
Other: Psychoeducational therapy
Combined Intervention of Cognitive Training and Supervised Physical Exercise
Also known as: Adapted physical activity
According 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.
Time frame: - Baseline - 12 weeks for intervention group - 16 weeks for control group
Objective Cognitive Function
It will be assessed with Near Infrared Spectroscopy (regional cerebral oxygen saturation).
Time frame: - Baseline - 12 weeks for intervention group - 16 weeks for control group
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
Time frame: - Baseline - 12 weeks for intervention group - 16 weeks for control group
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
Time frame: - Baseline - 12 weeks for intervention group - 16 weeks for control group
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
Time frame: - Baseline - 12 weeks for intervention group - 16 weeks for control group
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.
Time frame: - Baseline - 12 weeks for intervention group - 16 weeks for control group
Quality of life (QoL)
It will be measured using the European Organization for Research and Treatment of Cancer Quality of Life Core Questionnaire (EORTC QLQ-C30)
Time frame: - Baseline - 12 weeks for intervention group - 16 weeks for control group
Abdominal flexor endurance
It will be assessed using the McQuade Test (seconds)
Time frame: - Baseline - 12 weeks for intervention group
Upper body and back muscular strength
It will be assessed using trunk dynamometry (kg)
Time frame: - Baseline - 12 weeks for intervention group
Lower body endurance
It will be assessed using the 30-second sit-to-stand test (number of repetitions). The outcome is the number of repetitions completed, with a higher score indicating better lower limb strength and endurance.
Time frame: - Baseline - 12 weeks for intervention group
Perceived physical fitness
It will be assessed using the International Fitness Scale (IFIS). It comprises 5 items that evaluate overall fitness, cardiorespiratory fitness, muscular strength, speed-agility, and flexibility. Each item is rated on a 5-point Likert scale ranging from 1 (very poor) to 5 (very good). Higher scores indicate better perceived physical fitness.
Time frame: - Baseline - 12 weeks for intervention group
Functional exercise capacity
It will be assessed using the Six-Minute Walk Test (6MWT) (metres)
Time frame: - Baseline - 12 weeks for intervention group
Perceived effort
It will be assessed using the Borg Scale of Perceived Exertion.
Time frame: - 12 weeks for intervention group
Plan to share: No
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Universidad de Extremadura