Status:
RECRUITING
Unified Barlow Protocol (UP) in Cancer Survivors for Cognitive Impairments
Lead Sponsor:
Universidad de Córdoba
Conditions:
Cancer, Breast
Eligibility:
All Genders
18-70 years
Phase:
NA
Brief Summary
Background: Cognitive impairment appears frequently in cancer survivors, negatively affecting the quality of life and emotional well-being of patients. This study compares the effectiveness of a well-...
Eligibility Criteria
Inclusion
- Cancer diagnosis, stages I-III.
- Cancer type: Breast.
- Have received the last chemotherapy session in the last 6 months and a maximum of 6 years of treatment completion.
- Probable or mild to moderate cognitive impairment (score between 26 and 10 points according to the MMSE).
- Ability to be fluent in Spanish.
- Not currently participating in another clinical trial.
- Not currently receiving other psychological treatment
Exclusion
- Men and women aged \> 70 years.
- Diagnosis of cancer, stage IV or other types of cancer.
- Last chemotherapy session \< 6 months or \> 6 years.
- No cognitive impairment (MMSE score between 30 and 27 points).
- Diagnosis of mental disorder (including substance abuse) prior to cancer diagnosis.
- Relapse in disease after chemotherapy treatment is completed.
- Neurodevelopmental Disorder Diagnosis.
- Diagnosis of diseases that affect cognitive performance such as: hypertension, cardiac diseases, epilepsy, dementias, multiple sclerosis, functional disorders (fibromyalgia, chronic fatigue syndrome, irritable bowel syndrome, post-concussion syndrome, whiplash syndrome), CNS infections (HIV, encephalitis), metabolic disorders (diabetes, B12 deficiency), obstructive sleep apnea, brain damage (stroke, TBI, CNS cancer) and use of medications / substances that interfere with cognitive function such as pregabalin, gabapentin, topiramate, antidepressants tricyclics, sodium valproate, anticholinergics, methylphenidate, typical antipsychotics.
Key Trial Info
Start Date :
January 25 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2028
Estimated Enrollment :
123 Patients enrolled
Trial Details
Trial ID
NCT05289258
Start Date
January 25 2021
End Date
December 31 2028
Last Update
March 28 2025
Active Locations (2)
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1
Hospital Universitario Reina Sofía
Córdoba, Córdoba, Spain, 14005
2
Reina Sofía University Hospital
Córdoba, Córdoba, Spain