Набор скоро начнётся NCT07017530

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

Без фазы С лечением Breast Cancer

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: Cognitive training, Psychoeducational therapy.
Кому может быть актуально: Состояния в реестре: Breast Cancer. Базовые параметры: от 18 лет · Женщины.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: Испания
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

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

Обзор

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.

Вмешательства

Другое Cognitive training
Combined Intervention of Cognitive Training and Supervised Physical Exercise
Другое Psychoeducational therapy
According to standard clinical practice

Первичные конечные точки

Subjetive Cognitive function [Срок оценки: - Baseline - 12 weeks for intervention group - 16 weeks for control group]
Objective Cognitive Function [Срок оценки: - Baseline - 12 weeks for intervention group - 16 weeks for control group]

Вторичные конечные точки (11)

Fatigue [Срок оценки: - Baseline - 12 weeks for intervention group - 16 weeks for control group]
Sleep quality [Срок оценки: - Baseline - 12 weeks for intervention group - 16 weeks for control group]
Insomnia [Срок оценки: - Baseline - 12 weeks for intervention group - 16 weeks for control group]
Psychological distress [Срок оценки: - Baseline - 12 weeks for intervention group - 16 weeks for control group]
Quality of life (QoL) [Срок оценки: - Baseline - 12 weeks for intervention group - 16 weeks for control group]
Abdominal flexor endurance [Срок оценки: - Baseline - 12 weeks for intervention group]
Upper body and back muscular strength [Срок оценки: - Baseline - 12 weeks for intervention group]
Lower body endurance [Срок оценки: - Baseline - 12 weeks for intervention group]
Perceived physical fitness [Срок оценки: - Baseline - 12 weeks for intervention group]
Functional exercise capacity [Срок оценки: - Baseline - 12 weeks for intervention group]
Perceived effort [Срок оценки: - 12 weeks for intervention group]

Критерии участия

Критерии включения

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