Department of Radiation Oncology, Competence Center for Palliative Care, University Hospital Zurich and University of Zurich, Rämistrasse 100, 8091, Zurich, Switzerland.
Department of Gynecology, University Hospital Zurich, Zurich, Switzerland.
BMC Palliat Care. 2024 Mar 14;23(1):73. doi: 10.1186/s12904-024-01408-4.
This study extended the original Dignity Therapy (DT) intervention by including partners and family caregivers (FCs) of terminally-ill cancer patients with the overall aim of evaluating whether DT can mitigate distress in both patients nearing the end of life and their FCs.
In this multicenter, randomized controlled trial (RCT), a total of 68 patients with life expectancy < 6 months and clinically-relevant stress levels (Hospital Anxiety Depression total score; HADS ≥ 8) including their FCs were randomly assigned to DT, DT + (including their FCs), or standard palliative care (SPC) in a 1:1:1 ratio. Study participants were asked to complete a set of questionnaires pre- and post-intervention.
The coalesced group (DT and DT +) revealed a significant increase in patients' perceived quality of life (FACIT-Pal-14) following the intervention (mean difference 6.15, SD = 1.86, p < 0.01). We found a statistically significant group-by-time interaction effect: while the HADS of patients in the intervention group remained stable over the pre-post period, the control group's HADS increased (F = 4.33, df = 1, 82.9; p < 0.05), indicating a protective effect of DT. Most patients and their FCs found DT useful and would recommend it to other individuals in their situation.
The DT intervention has been well-received and shows the potential to increase HRQoL and prevent further mental health deterioration, illness burden and suffering in terminally-ill patients. The DT intervention holds the potential to serve as a valuable tool for facilitating end-of-life conversations among terminally-ill patients and their FCs. However, the implementation of DT within the framework of a RCT in a palliative care setting poses significant challenges. We suggest a slightly modified and less resource-intensive version of DT that is to provide the DT inventory to FCs of terminally-ill patients, empowering them to ask the questions that matter most to them over their loved one's final days.
This study was registered with Clinical Trial Registry (ClinicalTrials.gov -Protocol Record NCT02646527; date of registration: 04/01/2016). The CONSORT 2010 guidelines were used for properly reporting how the randomized trial was conducted.
本研究通过纳入终末期癌症患者的伴侣和家庭照顾者(FCs),扩展了最初的尊严疗法(DT)干预,总体目标是评估 DT 是否可以减轻接近生命终点的患者及其 FCs 的痛苦。
在这项多中心、随机对照试验(RCT)中,共有 68 名预期寿命<6 个月且存在临床相关压力水平(医院焦虑抑郁量表总分;HADS≥8)的终末期癌症患者及其 FCs 被随机分配至 DT、DT+(包括其 FCs)或标准姑息治疗(SPC)组,比例为 1:1:1。研究参与者被要求在干预前后完成一组问卷。
合并组(DT 和 DT+)在干预后患者感知的生活质量(FACIT-Pal-14)显著提高(平均差异 6.15,SD=1.86,p<0.01)。我们发现存在统计学上显著的组间时间交互效应:虽然干预组患者的 HADS 在预-后期间保持稳定,但对照组的 HADS 增加(F=4.33,df=1,82.9;p<0.05),表明 DT 具有保护作用。大多数患者及其 FCs 认为 DT 有用,并会将其推荐给他们所在情况下的其他人。
DT 干预措施受到了欢迎,并显示出有可能提高 HRQoL 并防止终末期患者的心理健康进一步恶化、疾病负担和痛苦。DT 干预措施有可能成为促进终末期患者及其 FCs 进行临终对话的有价值工具。然而,在姑息治疗环境中进行 RCT 框架内实施 DT 存在重大挑战。我们建议采用一种经过略微修改且资源消耗较少的 DT 版本,为终末期患者的 FCs 提供 DT 清单,使他们能够在其亲人的最后几天中提出对他们最重要的问题。
本研究在临床试验注册处(ClinicalTrials.gov-Protocol Record NCT02646527;注册日期:2016 年 4 月 1 日)进行了注册。本研究遵循 CONSORT 2010 指南,正确报告了随机试验的开展情况。