Cognitive remediation in breast cancer survivors: A study protocol

IF 2 3区 医学 Q3 MEDICINE, RESEARCH & EXPERIMENTAL
Pedro Alejandro Rodriguez Nunez , Véronique Gérat-Muller , Carine Bellera , Caroline Lalet , Bruno Quintard , Camille Chakiba , Virginie Postal
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引用次数: 0

Abstract

Cancer treatment-related cognitive impairment, also known as “Chemobrain,” is frequently reported among cancer survivors. This condition can persist for months after the end of cancer treatment and can affect various aspects of a patients' quality of life. Despite growing evidence, research into effective treatments remains an emerging field. This project aims to assess the effectiveness of a cognitive remediation protocol called Oncogite in reducing cancer treatment-related cognitive impairment. The primary outcomes are self-reported functional and emotional well-being. The secondary outcomes include measures of executive function (working memory, inhibition, shifting), episodic memory, perceived cognitive function and perceived quality of life. One hundred sixty-four breast cancer survivors will be recruited from an existing cohort. Patients will be randomized to either a cognitive remediation group or a no intervention group. Participation in the workshops will be via videoconferencing, led by a neuropsychologist. Patients in the experimental group will also have access to an internet platform with the exercises practiced between the group workshops. The intervention will last four months at a rate of one workshop per week. The following data will be collected: emotional and functional well-being, neurocognitive performance, switching, inhibition, cognitive complaints, episodic memory, fatigue and depression. We will conclude that the intervention is effective if there is 4-month improvement in both emotional and functional well-being to find in the experimental group in their cognitive functioning. This research will contribute to the development of new clinical tools for cancer treatment-related cognitive impairment and facilitate the return to work in cancer survivors.
乳腺癌幸存者的认知修复:一项研究方案
癌症治疗相关的认知障碍,也被称为“化学脑”,在癌症幸存者中经常被报道。这种情况会在癌症治疗结束后持续数月,并会影响患者生活质量的各个方面。尽管有越来越多的证据,但对有效治疗的研究仍然是一个新兴领域。该项目旨在评估一种名为Oncogite的认知修复方案在减少癌症治疗相关认知障碍方面的有效性。主要结果是自我报告的功能和情绪健康。次要结果包括执行功能(工作记忆、抑制、移位)、情景记忆、感知认知功能和感知生活质量的测量。将从现有的队列中招募164名乳腺癌幸存者。患者将被随机分为认知修复组和不干预组。参加研讨会将通过视频会议,由神经心理学家主持。实验组的患者还可以访问一个网络平台,在小组研讨会之间进行练习。干预将持续四个月,每周进行一次讲习班。将收集以下数据:情绪和功能健康、神经认知表现、转换、抑制、认知抱怨、情景记忆、疲劳和抑郁。如果实验组的认知功能在情绪和功能上都有4个月的改善,我们将得出干预是有效的结论。这项研究将有助于开发癌症治疗相关认知障碍的新临床工具,并促进癌症幸存者重返工作岗位。
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来源期刊
CiteScore
3.70
自引率
4.50%
发文量
281
审稿时长
44 days
期刊介绍: Contemporary Clinical Trials is an international peer reviewed journal that publishes manuscripts pertaining to all aspects of clinical trials, including, but not limited to, design, conduct, analysis, regulation and ethics. Manuscripts submitted should appeal to a readership drawn from disciplines including medicine, biostatistics, epidemiology, computer science, management science, behavioural science, pharmaceutical science, and bioethics. Full-length papers and short communications not exceeding 1,500 words, as well as systemic reviews of clinical trials and methodologies will be published. Perspectives/commentaries on current issues and the impact of clinical trials on the practice of medicine and health policy are also welcome.
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