Department of Psychology, University of Cordoba, Cordoba, Spain.
Maimonides Biomedical Research Institute of Cordoba (IMIBIC), Cordoba, Spain.
Trials. 2022 Sep 30;23(1):819. doi: 10.1186/s13063-022-06731-w.
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.
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.
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.
ClinicalTrials.gov NCT05289258. Registered 12 March 2022, v01.
癌症幸存者经常会出现认知障碍，这会对他们的生活质量和情绪健康产生负面影响。本研究比较了一种成熟的治疗方法（神经心理治疗）与统一情绪障碍跨诊断治疗方案（UP）对减少这些认知缺陷的效果，并评估这两种治疗方法对癌症幸存者的焦虑抑郁症状和生活质量的影响。
这是一项三臂、随机优势临床试验，采用 1:1:1 分配比的组间设计，包括预前后测和重复随访。将 123 名有轻度至中度认知障碍的癌症幸存者随机分配到以下三种研究干预措施之一：认知康复干预组、接受 UP 干预的干预组或等待名单上的对照组。主要结局是观察两组干预措施对认知功能的显著改善，以及与等待名单组相比情绪障碍的显著减少。预计也会有焦虑、抑郁和生活质量的改善作为次要结局。这些结果将在 6 个月的随访中得到维持。
本试验旨在测试 UP 干预对减少乳腺癌幸存者认知缺陷的疗效。该试验的结果可能有助于减少癌症幸存者认知问题的发生，并改善他们的情绪状态和生活质量。
ClinicalTrials.gov NCT05289258。于 2022 年 3 月 12 日注册，v01。
