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
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 220
- 试验地点
- 1
- 主要终点
- Subjetive Cognitive function
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Women with significant neurological conditions.
- •Women with psychiatric conditions.
- •Women with contraindications for physical exercise.
研究组 & 干预措施
Psychoeducational therapy after chemotherapy
Al list six months after the completion of chemotherapy.
干预措施: Psychoeducational therapy (Other)
Cognitive training + exercise group during chemotherapy
Al list two cycles of chemotherapy.
干预措施: Cognitive training (Other)
Cognitive training + exercise group after chemotherapy
Al list six months after the completion of chemotherapy.
干预措施: Cognitive training (Other)
Psychoeducational therapy during chemotherapy
Al list two cycles of chemotherapy.
干预措施: Psychoeducational therapy (Other)
结局指标
主要结局
Subjetive Cognitive function
时间窗: - 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
时间窗: - Baseline - 12 weeks for intervention group - 16 weeks for control group
It will be assessed with Near Infrared Spectroscopy (regional cerebral oxygen saturation).
次要结局
- Insomnia(- Baseline - 12 weeks for intervention group - 16 weeks for control group)
- Sleep quality(- Baseline - 12 weeks for intervention group - 16 weeks for control group)
- Quality of life (QoL)(- Baseline - 12 weeks for intervention group - 16 weeks for control group)
- Fatigue(- Baseline - 12 weeks for intervention group - 16 weeks for control group)
- Psychological distress(- Baseline - 12 weeks for intervention group - 16 weeks for control group)
- Upper body and back muscular strength(- Baseline - 12 weeks for intervention group)
- Lower body endurance(- Baseline - 12 weeks for intervention group)
- Functional exercise capacity(- Baseline - 12 weeks for intervention group)
- Abdominal flexor endurance(- Baseline - 12 weeks for intervention group)
- Perceived physical fitness(- Baseline - 12 weeks for intervention group)
- Perceived effort(- 12 weeks for intervention group)
研究者
Noelia Durán
Principal Investigator
Universidad de Extremadura