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

Universidad de Córdoba

Status: Enrolling

Conditions: Cancer, Breast

Treatments: Behavioral: Waitlist group; Behavioral: Neuropsychological treatment; Behavioral: Unified Protocol for the Transdiagnostic Treatment of Emotional Disorders (PU).

Study type: Interventional

Funder types: Other

Identifiers

NCT05289258

1380800-R

Details and patient eligibility

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.

Enrollment: 123 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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123 participants in 3 patient groups

Neuropsychological treatment

Active Comparator group

Description:

Combination of different neuropsychological rehabilitation programs

Treatment:

Behavioral: Neuropsychological treatment

Unified Protocol for the Transdiagnostic Treatment of Emotional Disorders (PU).

Experimental group

Description:

This intervention focuses on a deficit in emotional regulation common in all emotional disorders (ED).

Treatment:

Behavioral: Unified Protocol for the Transdiagnostic Treatment of Emotional Disorders (PU).

Waitlist group

Other group

Description:

The control group will receive the Adapted Mnesic Cognitive Training (ACTIVE) (Jobe, et al., 2001), as well as the Insight (Posit Science) program (Mahncke et al., 2006) once the interventions in groups 1 and 2 have been completed.

Treatment:

Behavioral: Waitlist group