Motor-cognitive Training Effects on Cognition in Breast Cancer Survivors: the BRAINonFIT Study (B… (NCT06073717) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Motor-cognitive Training Effects on Cognition in Breast Cancer Survivors: the BRAINonFIT Study (BRAINonFIT).
Spain108 participantsStarted 2024-10-01
Plain-language summary
The goal of this interventional study is to assess the effects of either physical exercise program or combined with cognitive training (dual motor and cognitive training program) on breast cancer survivors. The main questions it aims to answer are:
* Analyze the effectiveness of a supervised dual-task training program or a physical exercise program on the executive functions of the participants.
* Evaluate the impact of both interventions on physical function, emotional aspects, and important biomarkers related to muscle-brain crosstalk.
Participants will perform a 20-week supervised and controlled program, three times a week, along with weekly calorie and step challenges.
Researchers will compare the dual-task training group, with the physical exercise group, and with a control group, which will perform the guideline recommendations of physical activity (non-supervised) to see how these intervention approaches can impact cognitive functions, physical functions, emotional aspects, and biomarkers related to muscle-brain crosstalk.
Assessments will take place at three-time points: at baseline, after the intervention (20 weeks post-baseline) and after a 12-week follow-up period (32 weeks post-baseline).
Who can participate
Age range
25 Years – 65 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Diagnosed with stage I-IIIA breast cancer
* Completed primary treatment, including surgery, radiotherapy and/or chemotherapy
* Scheduled to receive adjuvant endocrine therapy, or currently receiving adjuvant endocrine therapy
* Without functional limitations or other illnesses that condition and prevent them from practising intense physical exercise
* FACT-Cog questionnaire score ≥ 10th percentile considering age groups
* Fluency in Spanish (spoken and written)
Exclusion Criteria:
* Undergoing radiotherapy and/or chemotherapy
* FACT-Cog questionnaire score ≤ 10th percentile considering age groups
* Congenital heart disease
* Chronic lung disease
* Severe psychiatric disorders
* History of substance abuse, or dependence (other than tobacco)
* Mood disorders require treatment (anxiety or depression)
* Relapses (2-3 months before the study start)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Executive Function (Cognitive Flexibility and Processing Speed)
Timeframe: Baseline (week 0); Post-intervention (25 weeks post-baseline); and Post-follow up (32 weeks post-baseline)