Actively Recruiting
Unified Barlow Protocol (UP) in Cancer Survivors for Cognitive Impairments
Led by Universidad de Córdoba · Updated on 2026-05-05
123
Participants Needed
2
Research Sites
413 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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 a control group on the waiting list. The primary outcome is to observe a significant improvement in cognitive function and quality of life in both intervention groups and a significant decrease in emotional impairments in comparison with the waitlist group. These results will be maintained at six months of follow-up. Discussion: The aim of this work is to test the efficacy of the Unified Barlow Protocol in reducing cognitive deficits in breast cancer survivors. The results of this trial may be useful in reducing the presence of cognitive problems in survivors and improving their emotional state and quality of life.
CONDITIONS
Official Title
Unified Barlow Protocol (UP) in Cancer Survivors for Cognitive Impairments
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Cancer diagnosis at stages I-III
- Breast cancer type
- Last chemotherapy session was between 6 months and 6 years ago
- Mild to moderate cognitive impairment with MMSE score between 10 and 26
- Ability to speak Spanish fluently
- Not currently participating in another clinical trial
- Not currently receiving other psychological treatment
You will not qualify if you...
- Age over 70 years
- Cancer stage IV or other cancer types
- Last chemotherapy session less than 6 months ago or more than 6 years ago
- No cognitive impairment with MMSE score between 27 and 30
- Mental disorder diagnosis (including substance abuse) before cancer diagnosis
- Disease relapse after chemotherapy treatment
- Neurodevelopmental disorder diagnosis
- Diseases affecting cognitive function 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, traumatic brain injury, CNS cancer)
- Use of medications or substances that affect cognitive function including pregabalin, gabapentin, topiramate, tricyclic antidepressants, sodium valproate, anticholinergics, methylphenidate, typical antipsychotics
AI-Screening
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Trial Site Locations
Total: 2 locations
1
Hospital Universitario Reina Sofía
Córdoba, Spain, 14005
Not Yet Recruiting
2
Reina Sofía University Hospital
Córdoba, Spain
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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