Breast Cancer
Conditions
Keywords
Breast cancer, Chemotherapy-Related Cognitive Impairment, Cognitive Training, Exercise, Oncology Nursing
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.
Interventions
OTHERCognitive training
Combined Intervention of Cognitive Training and Supervised Physical Exercise
OTHERPsychoeducational therapy
According to standard clinical practice
Sponsors
Universidad de Extremadura
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
| 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. |
| 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) |
| 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. |
| Upper body and back muscular strength | - Baseline - 12 weeks for intervention group | It will be assessed using trunk dynamometry (kg) |
| 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. |
| Functional exercise capacity | - Baseline - 12 weeks for intervention group | It will be assessed using the Six-Minute Walk Test (6MWT) (metres) |
| 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) |
| 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 |
Countries
Spain
Contacts
Primary ContactNoelia Durán-Gómez, PhD
Outcome results
None listed