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Unified Barlow Protocol (UP) in Cancer Survivors for Cognitive Impairments

RecruitingNAAges 18 Years - 70 YearsAllUniversidad de Córdoba
NCT05289258 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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-established treatment (cognitive rehabilitation) with the Unified Protocol for Transdiagnostic Treatment of Emotional Disorders (UP) to alleviate these cognitive deficits and evaluate its effect on anxiety-depressive symptoms and the quality of life of survivors. Methods: A three-arm randomized superiority clinical trial, with a pre-post and follow-up repeated measures and intergroup design with a 1:1:1 allocation ratio will be carried out. A hundred and twenty-three breast cancer survivors with mild to moderate cognitive impairment will be randomly assigned to one of the interventions of the study: cognitive rehabilitation intervention group, an intervention group with UP intervention, or

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📋 Eligibility rules (as published)
Inclusion Criteria: * 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 Criteria: * 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.
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What it tests

  • Neuropsychological treatment
  • Unified Protocol for the Transdiagnostic Treatment of Emotional Disorders (PU).
  • Waitlist group
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Where

2 sites
Hospital Universitario Reina Sofía
Córdoba, Spain
Reina Sofía University Hospital
Córdoba, Spain
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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