Clinical trial NCT07017530: Cognitive Training and Exercise for Women With Breast Cancer and Cognitive Impairment
Official title: Combined Intervention of Cognitive Training and Supervised Physical Exercise for Women With Breast Cancer and Chemotherapy-Related Cognitive Impairment: Study Protocol for a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Breast Cancer
Keywords: Breast cancer
Chemotherapy-Related Cognitive Impairment
Cognitive Training
Exercise
Oncology Nursing
Lead sponsor: Universidad de Extremadura
Sponsor class: OTHER
First posted: 2025-06-12
Enrollment: 220
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Subjetive Cognitive function
timeFrame: - Baseline - 12 weeks for intervention group - 16 weeks for control group
measure: Objective Cognitive Function
timeFrame: - Baseline - 12 weeks for intervention group - 16 weeks for control group
Secondary outcomes:
measure: Fatigue
timeFrame: - Baseline - 12 weeks for intervention group - 16 weeks for control group
measure: Sleep quality
timeFrame: - Baseline - 12 weeks for intervention group - 16 weeks for control group
measure: Insomnia
timeFrame: - Baseline - 12 weeks for intervention group - 16 weeks for control group
measure: Psychological distress
timeFrame: - Baseline - 12 weeks for intervention group - 16 weeks for control group
measure: Quality of life (QoL)
timeFrame: - Baseline - 12 weeks for intervention group - 16 weeks for control group
measure: Abdominal flexor endurance
timeFrame: - Baseline - 12 weeks for intervention group
measure: Upper body and back muscular strength
timeFrame: - Baseline - 12 weeks for intervention group
measure: Lower body endurance
timeFrame: - Baseline - 12 weeks for intervention group
measure: Perceived physical fitness
timeFrame: - Baseline - 12 weeks for intervention group
measure: Functional exercise capacity
timeFrame: - Baseline - 12 weeks for intervention group
measure: Perceived effort
timeFrame: - 12 weeks for intervention group
Other outcomes:
Locations:
city: Badajoz
country: Spain
facility: Facultad de Medicina y Ciencias de la Salud
Study officials:
References: