Breast CancerCHEMO-CogExNCT07017530
Cognitive Training and Exercise for Women With Breast Cancer and Cognitive Impairment
A study testing Cognitive training and Psychoeducational therapy in people with Breast Cancer, run by Universidad de Extremadura at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Cognitive training and Psychoeducational therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 220 participants
- Where
- 1 siteSpain
- Study dates
- 1 Sep 2025to 31 Aug 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Women with significant neurological conditions.
- Women with psychiatric conditions.
- Women with contraindications for physical exercise.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site
Facultad de Medicina y Ciencias de la Salud
Badajoz, Badajoz, 06006
Noelia Durán-Gómez, +34924289466, nduran@unex.es
About this study
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
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.
- Conditions
- Breast Cancer
- Being tested
- Cognitive training, Psychoeducational therapy
- Keywords
- Breast cancer, Chemotherapy-Related Cognitive Impairment, Cognitive Training, Exercise, Oncology Nursing
- Medical subject headings
- Breast Neoplasms, Chemotherapy-Related Cognitive Impairment, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive trainingOther
Also called Adapted physical activity
Combined Intervention of Cognitive Training and Supervised Physical Exercise
Psychoeducational therapyOther
According to standard clinical practice
| Study group | Role | What they receive |
|---|---|---|
| Cognitive training + exercise group during chemotherapy | Experimental | Al list two cycles of chemotherapy. Receives: Other: Cognitive training |
| Cognitive training + exercise group after chemotherapy | Experimental | Al list six months after the completion of chemotherapy. Receives: Other: Cognitive training |
| Psychoeducational therapy during chemotherapy | Active comparator | Al list two cycles of chemotherapy. Receives: Other: Psychoeducational therapy |
| Psychoeducational therapy after chemotherapy | Active comparator | Al list six months after the completion of chemotherapy. Receives: Other: Psychoeducational therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Subjetive Cognitive function
It will be assessed using subjective cognitive function measured by Functional Assessment of Cancer Therapy-Cognition (FACT-Cog) scale.
Measured: - Baseline - 12 weeks for intervention group - 16 weeks for control group
Objective Cognitive Function
It will be assessed with Near Infrared Spectroscopy (regional cerebral oxygen saturation).
Measured: - Baseline - 12 weeks for intervention group - 16 weeks for control group
Secondary outcomes (11)
Fatigue
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
Measured: - Baseline - 12 weeks for intervention group - 16 weeks for control group
Sleep quality
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
Measured: - Baseline - 12 weeks for intervention group - 16 weeks for control group
Insomnia
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
Measured: - Baseline - 12 weeks for intervention group - 16 weeks for control group
Psychological distress
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.
Measured: - Baseline - 12 weeks for intervention group - 16 weeks for control group
Quality of life (QoL)
It will be measured using the European Organization for Research and Treatment of Cancer Quality of Life Core Questionnaire (EORTC QLQ-C30)
Measured: - Baseline - 12 weeks for intervention group - 16 weeks for control group
Abdominal flexor endurance
It will be assessed using the McQuade Test (seconds)
Measured: - Baseline - 12 weeks for intervention group
Upper body and back muscular strength
It will be assessed using trunk dynamometry (kg)
Measured: - Baseline - 12 weeks for intervention group
Lower body endurance
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.
Measured: - Baseline - 12 weeks for intervention group
Perceived physical fitness
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.
Measured: - Baseline - 12 weeks for intervention group
Functional exercise capacity
It will be assessed using the Six-Minute Walk Test (6MWT) (metres)
Measured: - Baseline - 12 weeks for intervention group
Perceived effort
It will be assessed using the Borg Scale of Perceived Exertion.
Measured: - 12 weeks for intervention group
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2025
- Study start1 Sep 2025 (estimated)
- Primary completionSep 2026 (estimated)
- Study completion31 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 220 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad de Extremadura
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Noelia Durán, Universidad de Extremadura
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07017530
- Sponsor's protocol ID
- CEI 044/23
- Acronym
- CHEMO-CogEx
- Status last verified
- Jun 2025
- First submitted
- 14 May 2025
- Last updated
- 12 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07017530
- Acronym / sponsor ID
- CHEMO-CogEx / CEI 044/23
- Conditions
- Breast Cancer
- Keywords
- Breast cancer, Chemotherapy-Related Cognitive Impairment, Cognitive Training, Exercise, Oncology Nursing
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 220 participants (estimated)
- Lead sponsor
- Universidad de ExtremaduraUniversity, hospital or other
- Study start
- 1 Sep 2025 (estimated)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- 31 Aug 2028 (estimated)
- First posted
- 12 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Cognitive training + exercise group during chemotherapy | Experimental | Other: Cognitive trainingAl list two cycles of chemotherapy. |
| Cognitive training + exercise group after chemotherapy | Experimental | Other: Cognitive trainingAl list six months after the completion of chemotherapy. |
| Psychoeducational therapy during chemotherapy | Active comparator | Other: Psychoeducational therapyAl list two cycles of chemotherapy. |
| Psychoeducational therapy after chemotherapy | Active comparator | Other: Psychoeducational therapyAl list six months after the completion of chemotherapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- Women with significant neurological conditions.
- Women with psychiatric conditions.
- Women with contraindications for physical exercise.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive trainingAlso: Adapted physical activityCombined Intervention of Cognitive Training and Supervised Physical Exercise | Other | Cognitive training + exercise group after chemotherapy, Cognitive training + exercise group during chemotherapy |
| Psychoeducational therapyAccording to standard clinical practice | Other | Psychoeducational therapy after chemotherapy, Psychoeducational therapy during chemotherapy |
Primary outcome
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.
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).
11 secondary outcomes
Fatigue
Time frame: - Baseline - 12 weeks for intervention group - 16 weeks for control group
Sleep quality
Time frame: - Baseline - 12 weeks for intervention group - 16 weeks for control group
Insomnia
Time frame: - Baseline - 12 weeks for intervention group - 16 weeks for control group
Psychological distress
Time frame: - Baseline - 12 weeks for intervention group - 16 weeks for control group
Quality of life (QoL)
Time frame: - Baseline - 12 weeks for intervention group - 16 weeks for control group
Abdominal flexor endurance
Time frame: - Baseline - 12 weeks for intervention group
Upper body and back muscular strength
Time frame: - Baseline - 12 weeks for intervention group
Lower body endurance
Time frame: - Baseline - 12 weeks for intervention group
Perceived physical fitness
Time frame: - Baseline - 12 weeks for intervention group
Functional exercise capacity
Time frame: - Baseline - 12 weeks for intervention group
Perceived effort
Time frame: - 12 weeks for intervention group
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive training and Psychoeducational therapy in people with Breast Cancer, run by Universidad de Extremadura at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 12 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Noelia Durán-Gómez, PhD (+34924289466, nduran@unex.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Subjetive Cognitive function (time frame: - Baseline - 12 weeks for intervention group - 16 weeks for control group). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2025.