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

Overview

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.

Interventions

• Behavioral Neuropsychological treatment
  combination of the programs tested by (Von Ah et al. 2012). These programs are, on the one hand, a cognitive training adapted from the Advanced Cognitive Training for Independent and Vital Elderly (ACTIVE) (Jobe et al., 2001) and, on the other, a processing speed training using the Insight program (from Posit Science) (Mahncke et al., 2006). The first consists of teaching patients memorization techniques, and the second consists of a series of exercises on information processing of varying diffi
• Behavioral Unified Protocol for the Transdiagnostic Treatment of Emotional Disorders (PU).
  This intervention focuses on a deficit in emotional regulation common in all emotional disorders (ED). Therefore, it focuses on the adaptive value of emotions and promotes tolerance to intense emotions as well as the identification and modification of dysfunctional emotional regulation strategies. Patients receive 10 group therapy sessions (3-5 cancer survivors per group) with all PU modules (Barlow et al., 2011). The Spanish version of the therapist's guide and the patient's workbook are used (
• Behavioral Waitlist group
  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.

Primary outcome measures

• Functional assessment of Cancer Therapy-Cognitive Function, version 3. (FACT-Cog). [Time frame: Change of mean scores from baseline to immediately after intervention]
• Memory Failures Everyday (MFE-30). [Time frame: Change of mean scores from baseline to immediately after intervention]
• Hopkins Verbal Learning Test-Revised (HVLT-R). [Time frame: Change of mean scores from baseline to immediately after intervention]
• Trail Making Test (TMT). [Time frame: Change of mean scores from baseline to immediately after intervention]
• Controlled Oral Word Association Test (COWAT). [Time frame: Change of mean scores from baseline to immediately after intervention]

Secondary outcome measures (2)

• Hospital Anxiety and Depression Scale (HADS) [Time frame: Change of mean scores from baseline to immediately after intervention]]
• Quality of Life scores using EORTC QLQ C-30. [Time frame: Change of mean scores from baseline to immediately after intervention]]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Triple blind

Primary purpose

Treatment

Study locations

Spain · 2 centers

• Hospital Universitario Reina Sofía — Córdoba
• Reina Sofía University Hospital — Córdoba

Publications

• 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- PMID 36175973

Identifiers

NCT: NCT05289258 · 1380800-R

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗