NCT05289258 Unified Barlow Protocol (UP) in Cancer Survivors for Cognitive Impairments
| NCT ID | NCT05289258 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Universidad de Córdoba |
| Condition | Cancer, Breast |
| Study Type | INTERVENTIONAL |
| Enrollment | 123 participants |
| Start Date | 2021-01-25 |
| Primary Completion | 2026-12-30 |
Eligibility & Interventions
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 123 participants in total. It began in 2021-01-25 with a primary completion date of 2026-12-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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-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.
Eligibility Criteria
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.
Frequently Asked Questions
Who can join the NCT05289258 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 70 Years, studying Cancer, Breast. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05289258 currently recruiting?
Yes, NCT05289258 is actively recruiting participants. Visit ClinicalTrials.gov or contact Universidad de Córdoba to inquire about joining.
Where is the NCT05289258 trial being conducted?
This trial is being conducted at Córdoba, Spain, Córdoba, Spain.
Who is sponsoring the NCT05289258 clinical trial?
NCT05289258 is sponsored by Universidad de Córdoba. The trial plans to enroll 123 participants.
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