Cognitive treatment for breast cancer survivors with cognitive impairments
Effectiveness of Cognitive Rehabilitation and the Unified Barlow Protocol (UP) in Cancer Survivors for Cognitive Impairments: a Randomized Controlled Trial
This study is testing a new emotional treatment to see if it helps breast cancer survivors with thinking problems feel better and improve their quality of life compared to standard therapy.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 123 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Universidad de Córdoba Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 2 sites (Córdoba and 1 other locations) |
| Trial ID | NCT05289258 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness of the Unified Protocol for Transdiagnostic Treatment of Emotional Disorders (UP) compared to traditional cognitive rehabilitation in alleviating cognitive deficits in breast cancer survivors. The study involves a three-arm randomized design with 123 participants who will be assigned to either the UP intervention, cognitive rehabilitation, or a waitlist control group. The primary goal is to assess improvements in cognitive function, anxiety, depression, and overall quality of life among the participants over time.
Who should consider this trial
Good fit: Ideal candidates are breast cancer survivors aged 18-70 who have experienced mild to moderate cognitive impairment after completing chemotherapy within the last 6 years.
Not a fit: Patients with stage IV cancer, severe cognitive impairment, or those currently receiving other psychological treatments may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could significantly improve cognitive function and emotional well-being in breast cancer survivors.
How similar studies have performed: Previous studies have shown promise in using cognitive rehabilitation and emotional disorder treatments for similar patient populations, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Córdoba and 1 other locations
- Hospital Universitario Reina Sofía — Córdoba, Spain (Not_yet_recruiting)
- Reina Sofía University Hospital — Córdoba, Spain (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.