BACKGROUND Grieving relatives can suffer from numerous consequences like anxiety, depression, post-traumatic stress disorder (PTSD) symptoms, and prolonged grief. This study aims to assess the psychological consequences of grieving relatives after patients' death in French palliative care units and their needs for support. METHODS This is a prospective observational multicenter mixed study. Relatives of adult patients with a neoplasia expected to be hospitalized more than 72 h in a palliative care unit for end-of-life issues will be included within 48 h after patient admission. End-of-life issues are defined by the physician at patient admission. Relatives who are not able to have a phone call at 6-months are excluded. The primary outcome is the incidence of prolonged grief reaction defined by an ICG (Inventory Complicate Grief) > 25 (0 best-76 worst) at 6 months after patient' death. Prespecified secondary outcomes are the risk factors of prolonged grief, anxiety and depression symptoms between day 3 and day 5 and at 6 months after patients' death based on an Hospital Anxiety and Depression score (range 0-42) > 8 for each subscale (minimal clinically important difference: 2.5), post-traumatic stress disorder symptoms 6 months after patient' death based on the Impact of Events Scale questionnaire (0 best-88 worst) score > 22, experience of relatives during palliative care based on the Fami-Life questionnaire, specifically built for the study. Between 6 and 12 months after the patient's death, a phone interview with relatives with prolonged grief reactions will be planned by a psychologist to understand the complex system of grief. It will be analyzed with the Interpretative Phenomenological Analysis. We planned to enroll 500 patients and their close relatives assuming a 25% prolonged grief rate and a 6-month follow-up available in 60% of relatives. DISCUSSION This study will be the first to report the psychological consequences of French relatives after a loss of a loved one in palliative care units. Evaluating relatives' experiences can provide instrumental insights for means of improving support for relatives and evaluation of bereavement programs. TRIAL REGISTRATION NCT03748225 registered on 11/19/2018. Recruiting patients.

中文翻译：

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《家庭生活研究》：一项代表法国姑息治疗家庭研究（FRIPC研究网络）的前瞻性观察性多中心混合研究方案，旨在研究法国姑息治疗部门悲伤的亲属的心理后果。

背景技术悲伤的亲属会遭受许多后果，例如焦虑，沮丧，创伤后应激障碍（PTSD）症状和长时间的悲伤。这项研究旨在评估法国姑息治疗病房患者死亡后悲痛的亲属的心理后果以及他们的支持需求。方法这是一项前瞻性观察性多中心混合研究。预期入院后48小时内将包括成年瘤的成年患者的亲属，这些亲戚预计将在姑息治疗病房住院72小时以上，以解决临终问题。生命终止问题由医师在患者入院时定义。无法在6个月内打通电话的亲戚。主要结果是ICG（清单复杂性悲伤）定义的长时间悲伤反应发生率> 患者死亡6个月后为25（0分，最差76分）。预先确定的次要结局是根据患者的焦虑和抑郁评分（范围0-42）> 8（针对每个分量表，最小值），在患者死亡后第3天至第5天以及患者死亡后6个月内出现长时间的悲伤，焦虑和抑郁症状的危险因素。临床上的重要差异：2.5），患者死亡后6个月的创伤后应激障碍症状，基于事件影响量表（0佳-88最低）得分> 22，基于Fami-Life的姑息治疗亲属经历专门为研究而设计的问卷。在患者死亡后的6到12个月之间，心理学家将计划与长期悲伤反应的亲戚进行电话采访，以了解复杂的悲伤系统。将使用解释现象学分析进行分析。我们计划招募500名患者及其近亲，假设长期悲伤率提高25％，并在60％的亲属中进行6个月的随访。讨论本研究将是第一个报告姑息治疗病房失去亲人后法国亲属的心理后果的研究。评估亲属的经验可以提供工具性见解，以改善对亲属的支持和丧亲计划的评估。试用注册NCT03748225于2018年11月19日注册。招募病人。讨论本研究将是第一个报告姑息治疗病房失去亲人后法国亲属的心理后果的研究。评估亲属的经验可以提供工具性见解，以改善对亲属的支持和丧亲计划的评估。试用注册NCT03748225于2018年11月19日注册。招募病人。讨论本研究将是第一个报告姑息治疗病房失去亲人后法国亲属的心理后果的研究。评估亲属的经验可以提供工具性见解，以改善对亲属的支持和丧亲计划的评估。试用注册NCT03748225于2018年11月19日注册。招募病人。