Effectiveness of the Unified Barlow Protocol (UP) and neuropsychological treatment in cancer survivors for cognitive impairments: study protocol for a randomized controlled trial
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 Tr...
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| Format: | Article |
| Language: | English |
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BMC
2022-09-01
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| Series: | Trials |
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| Online Access: | https://doi.org/10.1186/s13063-022-06731-w |
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| author | 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 |
| author_facet | 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 |
| author_sort | Francisco García-Torres |
| collection | DOAJ |
| description | 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. |
| first_indexed | 2024-12-10T04:24:47Z |
| format | Article |
| id | doaj.art-6cd7c64eb94b48e2b6699c48bc244497 |
| institution | Directory Open Access Journal |
| issn | 1745-6215 |
| language | English |
| last_indexed | 2024-12-10T04:24:47Z |
| publishDate | 2022-09-01 |
| publisher | BMC |
| record_format | Article |
| series | Trials |
| spelling | doaj.art-6cd7c64eb94b48e2b6699c48bc2444972022-12-22T02:02:18ZengBMCTrials1745-62152022-09-0123111310.1186/s13063-022-06731-wEffectiveness of the Unified Barlow Protocol (UP) and neuropsychological treatment in cancer survivors for cognitive impairments: study protocol for a randomized controlled trialFrancisco García-Torres0Adrián Tejero-Perea1Ángel Gómez-Solís2Rosario Castillo-Mayén3Maria José Jaén-Moreno4Bárbara Luque5Mario Gálvez-Lara6Araceli Sánchez-Raya7Marcin Jablonski8Beatriz Rodríguez-Alonso9Enrique Aranda10Department of Psychology, University of CordobaDepartment of Psychology, University of CordobaReina Sofía University Hospital of CordobaDepartment of Psychology, University of CordobaMaimonides Biomedical Research Institute of Cordoba (IMIBIC)Department of Psychology, University of CordobaDepartment of Psychology, University of CordobaDepartment of Psychology, University of CordobaCollegium Medicum Jan Kochanowski, University in KielceMaimonides Biomedical Research Institute of Cordoba (IMIBIC)Medical Oncology Department, Reina Sofía University HospitalAbstract 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.https://doi.org/10.1186/s13063-022-06731-wOncologyCancerUnified Protocol for Transdiagnostic Treatment of Emotional Disorders (UP)Cognitive impairmentQuality of lifeAnxiety and depression |
| spellingShingle | 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 Effectiveness of the Unified Barlow Protocol (UP) and neuropsychological treatment in cancer survivors for cognitive impairments: study protocol for a randomized controlled trial Trials Oncology Cancer Unified Protocol for Transdiagnostic Treatment of Emotional Disorders (UP) Cognitive impairment Quality of life Anxiety and depression |
| title | Effectiveness of the Unified Barlow Protocol (UP) and neuropsychological treatment in cancer survivors for cognitive impairments: study protocol for a randomized controlled trial |
| title_full | Effectiveness of the Unified Barlow Protocol (UP) and neuropsychological treatment in cancer survivors for cognitive impairments: study protocol for a randomized controlled trial |
| title_fullStr | Effectiveness of the Unified Barlow Protocol (UP) and neuropsychological treatment in cancer survivors for cognitive impairments: study protocol for a randomized controlled trial |
| title_full_unstemmed | Effectiveness of the Unified Barlow Protocol (UP) and neuropsychological treatment in cancer survivors for cognitive impairments: study protocol for a randomized controlled trial |
| title_short | Effectiveness of the Unified Barlow Protocol (UP) and neuropsychological treatment in cancer survivors for cognitive impairments: study protocol for a randomized controlled trial |
| title_sort | effectiveness of the unified barlow protocol up and neuropsychological treatment in cancer survivors for cognitive impairments study protocol for a randomized controlled trial |
| topic | Oncology Cancer Unified Protocol for Transdiagnostic Treatment of Emotional Disorders (UP) Cognitive impairment Quality of life Anxiety and depression |
| url | https://doi.org/10.1186/s13063-022-06731-w |
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