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

NCT ID: NCT05289258

Last Updated: 2025-03-28

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 123 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-01-25
• Study Completion Date: 2028-12-31

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.

Conditions

Cancer, Breast

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Neuropsychological treatment

Combination of different neuropsychological rehabilitation programs

Group Type: ACTIVE_COMPARATOR

Neuropsychological treatment

Intervention Type: BEHAVIORAL

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.

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).

Group Type: EXPERIMENTAL

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

Intervention Type: BEHAVIORAL

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.

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.

Group Type: OTHER

Waitlist group

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: 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 Type: BEHAVIORAL

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Universidad de Córdoba

OTHER

Sponsor Role: lead

Responsible Party

Francisco Garcia Torres

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Hospital Universitario Reina Sofía

Córdoba, Córdoba, Spain

Site Status: NOT_YET_RECRUITING

Reina Sofía University Hospital

Córdoba, Córdoba, Spain

Site Status: RECRUITING

Countries

Spain

Facility Contacts

Enrique Aranda, PhD

Role: primary

earandaa@seom.org

957 011 638

Francisco Garcia Torres, PhD

Role: primary

z12gatof@uco.es

+3495721 ext. 8847

References

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.

Reference Type: DERIVED

PMID: 36175973 (View on PubMed)

Other Identifiers

1380800-R

Identifier Type: -

Identifier Source: org_study_id