Clinical trial NCT05289258: Unified Barlow Protocol (UP) in Cancer Survivors for Cognitive Impairments
Official title: Effectiveness of Cognitive Rehabilitation and the Unified Barlow Protocol (UP) in Cancer Survivors for Cognitive Impairments: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cancer, Breast
Keywords: Unified Protocol for Transdiagnostic Treatment of Emotional Disorders (UP)
cognitive impairments
quality of life
anxiety and depression.
Lead sponsor: Universidad de Córdoba
Sponsor class: OTHER
First posted: 2022-03-21
Enrollment: 123
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This study is a three-arm randomized clinical trial, with a pre-post-follow-up repeated measures intergroup design.
Primary purpose: TREATMENT

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.

Primary outcomes:
measure: Functional assessment of Cancer Therapy-Cognitive Function, version 3. (FACT-Cog).
timeFrame: Change of mean scores from baseline to immediately after intervention
measure: Memory Failures Everyday (MFE-30).
timeFrame: Change of mean scores from baseline to immediately after intervention
measure: Hopkins Verbal Learning Test-Revised (HVLT-R).
timeFrame: Change of mean scores from baseline to immediately after intervention
measure: Trail Making Test (TMT).
timeFrame: Change of mean scores from baseline to immediately after intervention
measure: Controlled Oral Word Association Test (COWAT).
timeFrame: Change of mean scores from baseline to immediately after intervention
Secondary outcomes:
measure: Hospital Anxiety and Depression Scale (HADS)
timeFrame: Change of mean scores from baseline to immediately after intervention]
measure: Quality of Life scores using EORTC QLQ C-30.
timeFrame: Change of mean scores from baseline to immediately after intervention]
Other outcomes:
Locations:
city: Córdoba
country: Spain
facility: Hospital Universitario Reina Sofía
city: Córdoba
country: Spain
facility: Reina Sofía University Hospital
Study officials:
References:
citation: Garcia-Torres F, Tejero-Perea A, Gomez-Solis A, Castillo-Mayen R, Jaen-Moreno MJ, Luque B, Galvez-Lara M, Sanchez-Raya A, Jablonski M, Rodriguez-Alonso B, Aranda E. Effectiveness of the Unified Barlow Protocol (UP) and neuropsychological treatment in cancer survivors for cognitive impairments: study protocol for a randomized controlled trial. Trials. 2022 Sep 30;23(1):819. doi: 10.1186/s13063-022-06731-w.