Normandie Université, UNICAEN, PSL Université, EPHE, INSERM, U1077, CHU de Caen, Neuropsychologie et Imagerie de la Mémoire Humaine, 14000, Caen, France.
Clinical Research Department, Centre François Baclesse, 14076, Caen, France.
BMC Cancer. 2018 Sep 3;18(1):866. doi: 10.1186/s12885-018-4762-2.
Breast cancer (BC) is the most frequent cancer in women with more than 70% of BC patients being treated with hormonal therapy (HT). Among these patients, some report difficulties in remembering what they are supposed to do at the right moment, referring to prospective memory (PM). PM is essential for autonomy and medical adherence of patients, and requires an ecological assessment. Virtual reality, that recreates naturalistic environment, seems to be a promising method to evaluate PM. Several BC patients also report sleep disturbances. Given the role of sleep on memory consolidation, it is imperative to explore the influence of sleep quality on PM in BC patients treated with HT. The purpose of PROSOM-K study is to assess PM functioning using virtual reality and sleep quality in BC treated or not with HT.
PROSOM-K is a prospective study including post-menopausal BC patients ≤70 years old treated with radiotherapy (n = 25) or with radiotherapy and HT (n = 25), and healthy post-menopausal women (n = 25) matched for age and education. PM will be assessed using a virtual reality based task. Other cognitive functions and psychosocial factors will be assessed with validated questionnaires and neuropsychological tests. The study is divided in 3 sessions: a session of familiarisation with the virtual environment and the PM task: a day-time session during which participants learn intentions during the morning and recall them in the evening; and a night-time session during which participants learn intentions in the evening and recall them the following morning. Women will be monitored by wrist actigraphy; during the night-time session, objective sleep quality and quantity will be measured by polysomnography.
This is a novel study aiming to assess PM using virtual reality, coupled with the evaluation of other cognitive functions. Polysomnographic study of sleep will provide further information about architectural sleep disturbances in BC. Association between sleep architecture parameters and PM mechanism in BC women treated with HT will be described in detail. We expect our results will provide knowledge for patients and clinicians and further help to improve patient care and cognitive therapy.
NCT03420105 , registered: January 10, 2018.
乳腺癌(BC)是女性中最常见的癌症,超过 70%的 BC 患者接受激素治疗(HT)。其中一些患者报告说,他们在正确的时刻难以记住自己应该做什么,这被称为前瞻性记忆(PM)。PM 对患者的自主性和医疗依从性至关重要,需要进行生态评估。虚拟现实,即再现自然环境,似乎是评估 PM 的一种很有前途的方法。一些 BC 患者还报告睡眠障碍。鉴于睡眠对记忆巩固的作用,有必要探讨 HT 治疗的 BC 患者的睡眠质量对 PM 的影响。PROSOM-K 研究的目的是使用虚拟现实和睡眠质量评估接受或不接受 HT 治疗的 BC 患者的 PM 功能。
PROSOM-K 是一项前瞻性研究,包括接受放疗(n=25)或放疗和 HT(n=25)治疗的绝经后≤70 岁的 BC 患者和年龄和教育程度相匹配的健康绝经后女性(n=25)。PM 将使用基于虚拟现实的任务进行评估。其他认知功能和心理社会因素将使用经过验证的问卷和神经心理学测试进行评估。该研究分为 3 个阶段:一个是熟悉虚拟现实和 PM 任务的阶段:一个是白天阶段,参与者在早上学习意图并在晚上回忆;一个是夜间阶段,参与者在晚上学习意图并在第二天早上回忆。女性将通过腕部活动记录仪进行监测;在夜间阶段,通过多导睡眠图测量客观睡眠质量和数量。
这是一项使用虚拟现实评估 PM 的新研究,同时评估其他认知功能。对睡眠结构的多导睡眠图研究将提供更多关于 BC 中睡眠结构障碍的信息。HT 治疗的 BC 女性的睡眠结构参数与 PM 机制之间的关系将详细描述。我们预计我们的结果将为患者和临床医生提供知识,并进一步帮助改善患者护理和认知治疗。
NCT03420105,注册日期:2018 年 1 月 10 日。