Cognitive Training and Exercise for Women With Breast Cancer and Cognitive Impairment

Not Applicable

Not yet recruiting

• Conditions: Breast Cancer

• Registration Number: NCT07017530
• Lead Sponsor: Universidad de Extremadura

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-05-14
• Status Verified: 2025-06
• Study First Submitted QC: 2025-06-03
• Last Update Submitted: 2025-06-03
• Study First Posted: 2025-06-12
• Last Update Posted: 2025-06-12
• Study Start: 2025-09-01
• Primary Completion: 2026-09
• Study Completion: 2028-08-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 220

Inclusion Criteria

• 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

Exclusion Criteria

• Women with significant neurological conditions.
• Women with psychiatric conditions.
• Women with contraindications for physical exercise.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Subjetive Cognitive function	- Baseline - 12 weeks for intervention group - 16 weeks for control group	It will be assessed using subjective cognitive function measured by Functional Assessment of Cancer Therapy-Cognition (FACT-Cog) scale.
Objective Cognitive Function	- Baseline - 12 weeks for intervention group - 16 weeks for control group	It will be assessed with Near Infrared Spectroscopy (regional cerebral oxygen saturation).

Secondary Outcome Measures

Name	Time	Method
Insomnia	- Baseline - 12 weeks for intervention group - 16 weeks for control group	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
Sleep quality	- Baseline - 12 weeks for intervention group - 16 weeks for control group	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
Quality of life (QoL)	- Baseline - 12 weeks for intervention group - 16 weeks for control group	It will be measured using the European Organization for Research and Treatment of Cancer Quality of Life Core Questionnaire (EORTC QLQ-C30)
Fatigue	- Baseline - 12 weeks for intervention group - 16 weeks for control group	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
Psychological distress	- Baseline - 12 weeks for intervention group - 16 weeks for control group	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.
Upper body and back muscular strength	- Baseline - 12 weeks for intervention group	It will be assessed using trunk dynamometry (kg)
Lower body endurance	- Baseline - 12 weeks for intervention group	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.
Functional exercise capacity	- Baseline - 12 weeks for intervention group	It will be assessed using the Six-Minute Walk Test (6MWT) (metres)
Perceived physical fitness	- Baseline - 12 weeks for intervention group	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.
Perceived effort	- 12 weeks for intervention group	It will be assessed using the Borg Scale of Perceived Exertion.
Abdominal flexor endurance	- Baseline - 12 weeks for intervention group	It will be assessed using the McQuade Test (seconds)

Trial Locations

Locations (1)

Facultad de Medicina y Ciencias de la Salud; 🇪🇸 Badajoz, Spain