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

Sponsor

Universidad de Córdoba (Other)

Overall Status

Recruiting

CT.gov ID

NCT05289258

Collaborator

(none)

123

Enrollment

Locations

Arms

8.2

Anticipated Duration (Months)

61.5

Patients Per Site

7.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cancer, Breast	Behavioral: Neuropsychological treatment Behavioral: Unified Protocol for the Transdiagnostic Treatment of Emotional Disorders (PU). Behavioral: Waitlist group	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

123 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

This study is a three-arm randomized clinical trial, with a pre-post-follow-up repeated measures intergroup design.This study is a three-arm randomized clinical trial, with a pre-post-follow-up repeated measures intergroup design.

Masking:

Triple (Participant, Care Provider, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Effectiveness of Cognitive Rehabilitation and the Unified Barlow Protocol (UP) in Cancer Survivors for Cognitive Impairments: a Randomized Controlled Trial

Actual Study Start Date :

Apr 25, 2022

Anticipated Primary Completion Date :

Aug 31, 2022

Anticipated Study Completion Date :

Dec 31, 2022

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Neuropsychological treatment Combination of different neuropsychological rehabilitation programs	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 difficulty. These exercises automatically adjust your difficulty to maintain an 85% rate of return. Treatment is carried out in groups of 10 cancer survivors. It consists of 10 weekly sessions of 2 hours each (the first hour for memory training and the second for processing speed exercises). In order to improve the adherence to treatment of the participants, emails and telephone text messages will be sent with reminders of appointments and tasks to be performed.
Experimental: 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).	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 (Barlow et al., 2015). All patients receive the workbook to help them read the contents of each session, do the recommended exercises between sessions, and to help them once the treatment is finished. The treatment lasts 10 weeks (one session a week). As in the previous intervention group, emails and telephone text messages will be used with reminders of appointments and tasks to be carried out.
Other: 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.	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.

Arm

Intervention/Treatment

Active Comparator: Neuropsychological treatment

Combination of different neuropsychological rehabilitation programs

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 difficulty. These exercises automatically adjust your difficulty to maintain an 85% rate of return. Treatment is carried out in groups of 10 cancer survivors. It consists of 10 weekly sessions of 2 hours each (the first hour for memory training and the second for processing speed exercises). In order to improve the adherence to treatment of the participants, emails and telephone text messages will be sent with reminders of appointments and tasks to be performed.

Experimental: 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).

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 (Barlow et al., 2015). All patients receive the workbook to help them read the contents of each session, do the recommended exercises between sessions, and to help them once the treatment is finished. The treatment lasts 10 weeks (one session a week). As in the previous intervention group, emails and telephone text messages will be used with reminders of appointments and tasks to be carried out.

Other: 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.

Behavioral: Waitlist group

Outcome Measures

Primary Outcome Measures

Functional assessment of Cancer Therapy-Cognitive Function, version 3. (FACT-Cog). [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
Memory Failures Everyday (MFE-30). [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
Hopkins Verbal Learning Test-Revised (HVLT-R). [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). [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
Controlled Oral Word Association Test (COWAT). [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.

Secondary Outcome Measures

Hospital Anxiety and Depression Scale (HADS) [Change of mean scores from baseline to immediately after intervention]]
This scale is used to assess anxiety and depression in a hospital settings. It is made up of 14 items (7 for anxiety and 7 for depression), which are answered on a scale from 0 to 3, with maximum values of 21 in each of the subscales. Higher scores indicates the presence of anxiety and depression.
Quality of Life scores using EORTC QLQ C-30. [Change of mean scores from baseline to immediately after intervention]]
EORTC QLQ C-30 (version 3), this is an instrument developed to assess the quality of life in cancer patients using 30 questions that refer to the quality of life experienced by the patient during the last week. The first twenty-eight items include questions about different symptoms and are answered on a scale that ranges from 1 (not at all) to 4 (a lot), while the last two ask patients about the perception of their global health and quality of life in a scale from 1 (terrible) to 7 (excellent). The different items are grouped into functional scales (physical / role / emotional / cognitive / social and global) and symptom scale (fatigue / nausea and vomiting / dyspnea / sleep problems / loss of appetite / constipation / diarrhea and financial impact ). Higher scores indicates a better function.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts 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.