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Published in: Trials 1/2022

Open Access 01-12-2022 | Mood Disorders | Study protocol

Effectiveness of the Unified Barlow Protocol (UP) and neuropsychological treatment in cancer survivors for cognitive impairments: study protocol for a randomized controlled trial

Authors: Francisco García-Torres, Adrián Tejero-Perea, Ángel Gómez-Solís, Rosario Castillo-Mayén, Maria José Jaén-Moreno, Bárbara Luque, Mario Gálvez-Lara, Araceli Sánchez-Raya, Marcin Jablonski, Beatriz Rodríguez-Alonso, Enrique Aranda

Published in: Trials | Issue 1/2022

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Abstract

Background

Cancer survivors frequently develop cognitive impairment, which negatively affects their quality of life and emotional well-being. This study compares the effectiveness of a well-established treatment (neuropsychological treatment) with the Unified Protocol for Transdiagnostic Treatment of Emotional Disorders (UP) to reduce these cognitive deficits and evaluate the effect of both treatments on anxiety-depressive symptoms and the quality of life of cancer survivors.

Methods

A three-arm, randomized superiority clinical trial with a pre-post and repeated follow-up measures intergroup design using a 1:1:1 allocation ratio will be performed. One hundred and twenty-three cancer survivors with mild to moderate cognitive impairment will be randomly assigned to one of the study interventions: a 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 in both intervention groups and a significant decrease in emotional impairments in comparison with the waitlist group. Improvements in anxiety, depression, and quality of life are also expected as secondary outcomes. These results will be maintained at 6 months of follow-up.

Discussion

The aim of this trial is to test the efficacy of the UP intervention in reducing cognitive deficits in breast cancer survivors. The results of this trial may be useful in reducing the presence of cognitive problems in cancer survivors and improving their emotional state and quality of life.

Trial registration

ClinicalTrials.​gov NCT05289258. Registered 12 March 2022, v01.
Appendix
Available only for authorised users
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Metadata
Title
Effectiveness of the Unified Barlow Protocol (UP) and neuropsychological treatment in cancer survivors for cognitive impairments: study protocol for a randomized controlled trial
Authors
Francisco García-Torres
Adrián Tejero-Perea
Ángel Gómez-Solís
Rosario Castillo-Mayén
Maria José Jaén-Moreno
Bárbara Luque
Mario Gálvez-Lara
Araceli Sánchez-Raya
Marcin Jablonski
Beatriz Rodríguez-Alonso
Enrique Aranda
Publication date
01-12-2022
Publisher
BioMed Central
Published in
Trials / Issue 1/2022
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-022-06731-w

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