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NCT Number: NCT07017530

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

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.

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Key information

Conditions

Breast Cancer Behavior Breast Diseases Breast Neoplasms Chemically-Induced Disorders Chemotherapy-Related Cognitive Impairment Cognition Disorders Cognitive Dysfunction Drug-Related Side Effects and Adverse Reactions Mental Disorders Motor Activity Neoplasms Neoplasms by Site Neurocognitive Disorders Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Cognitive Training

Other

Combined Intervention of Cognitive Training and Supervised Physical Exercise

Other names: Adapted physical activity

Psychoeducational therapy

Other

According to standard clinical practice

Primary outcomes

  1. Subjetive Cognitive function

    Time frame: - 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.

  2. Objective Cognitive Function

    Time frame: - Baseline - 12 weeks for intervention group - 16 weeks for control group

    It will be assessed with Near Infrared Spectroscopy (regional cerebral oxygen saturation).

Secondary outcomes

  1. Fatigue

    Time frame: - 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

  2. Sleep quality

    Time frame: - 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

  3. Insomnia

    Time frame: - 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

  4. Psychological distress

    Time frame: - 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.

  5. Quality of life (QoL)

    Time frame: - 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)

  6. Abdominal flexor endurance

    Time frame: - Baseline - 12 weeks for intervention group

    It will be assessed using the McQuade Test (seconds)

  7. Upper body and back muscular strength

    Time frame: - Baseline - 12 weeks for intervention group

    It will be assessed using trunk dynamometry (kg)

  8. Lower body endurance

    Time frame: - 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.

  9. Perceived physical fitness

    Time frame: - 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.

  10. Functional exercise capacity

    Time frame: - Baseline - 12 weeks for intervention group

    It will be assessed using the Six-Minute Walk Test (6MWT) (metres)

  11. Perceived effort

    Time frame: - 12 weeks for intervention group

    It will be assessed using the Borg Scale of Perceived Exertion.

Study contacts

Contact information is provided by the study sponsor or research team.

Noelia Durán-Gómez, PhD

CONTACT

[email protected]

+34924289466

Sponsors and collaborators

Lead sponsor

Universidad de Extremadura

Other

Registry information

Official study 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

Acronym: CHEMO-CogEx

Important dates

Study start
2025
Primary completion
2026
Study completion
2028
First posted
Jun 12, 2025
Registry last updated
Jun 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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