Effectiveness of Cognitive Rehabilitation and the Unified Barlow Protocol (UP) in Cancer Survivors for Cognitive Impairments: a Randomized Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 123
- Locations
- 3
- Primary Endpoint
- Controlled Oral Word Association Test (COWAT).
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Care Provider, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Neuropsychological treatment
Combination of different neuropsychological rehabilitation programs
Intervention: Neuropsychological treatment (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).
Intervention: Unified Protocol for the Transdiagnostic Treatment of Emotional Disorders (PU). (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.
Intervention: Waitlist group (Behavioral)
Outcomes
Primary Outcomes
Controlled Oral Word Association Test (COWAT).
Time Frame: Change of mean scores from baseline to immediately after intervention
The COWAT is a test that measures verbal fluency and is a recognized and sensitive indicator of cognitive functioning. the participant has to say as many words as possible in one minute, and a greater number of words is associated with greater verbal fluency.
Memory Failures Everyday (MFE-30).
Time Frame: Change of mean scores from baseline to immediately after intervention
It is a unifactorial questionnaire that measures a single construct: "cognitive complaints". It is made up of 30 items that are answered on a 5-point Likert scale from 1 (never) to 4 (always or almost always) with higher scores indicate poorer memory function. Scores are from 1 to with higher scores indicating higher memory impairments
Functional assessment of Cancer Therapy-Cognitive Function, version 3. (FACT-Cog).
Time Frame: Change of mean scores from baseline to immediately after intervention
This is an instrument developed to assess chemotherapy-induced cognitive problems in cancer patients. It includes four different subscales: Perceived Cognitive Impairments (score range from 0-72), Impact of Perceived Cognitive Impairments on QoL (score range from 0-16), Comments from Others (score range from 0-16), and Perceived Cognitive Abilities (scores range from 0-28) that are scored using a Likert scale of five points from 0 (never) to 4 (several times a day). The higher the score, the better the cognitive function
Hopkins Verbal Learning Test-Revised (HVLT-R).
Time Frame: Change of mean scores from baseline to immediately after intervention
This test measures primary and secondary memory, the rate of verbal learning throughout three trials, as well as three forms of mnesic organization: serial ordering, semantic grouping, and subjective organization. The test consists of a list of 12 words that are presented orally at a speed of one word for every two seconds. a higher number of words is interpreted as better recall and recognition
Trail Making Test (TMT).
Time Frame: Change of mean scores from baseline to immediately after intervention
The TMT consists of two parts: Part A measures attention, processing speed, visual search, and working memory; on the other hand, part B is used to measure attention, executive function (cognitive flexibility, ability to change tasks, coordination of categories), working memory, visual-motor skills and processing speed. A greater time to complete the tasks is interpreted as a greater deterioration
Secondary Outcomes
- Quality of Life scores using EORTC QLQ C-30.(Change of mean scores from baseline to immediately after intervention])
- Hospital Anxiety and Depression Scale (HADS)(Change of mean scores from baseline to immediately after intervention])
Investigators
Francisco Garcia Torres
Principal Investigator
Universidad de Córdoba