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Abstract：
BACKGROUND: 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.
METHODS: 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; HADStot ≥ 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.
RESULTS: 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 HADStot of patients in the intervention group remained stable over the pre-post period, the control group\'s HADStot 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.
CONCLUSIONS: 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.
BACKGROUND: 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.
METHODS: 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; HADStot ≥ 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.
RESULTS: 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 HADStot of patients in the intervention group remained stable over the pre-post period, the control group\'s HADStot 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.
CONCLUSIONS: 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.
BACKGROUND: 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.
摘要：
背景：这项研究扩展了最初的尊严疗法（DT）干预措施，纳入了终末期癌症患者的伴侣和家庭照顾者（FC），其总体目标是评估DT是否可以减轻接近生命终点的患者及其FC的痛苦。
方法：在这个多中心中，随机对照试验（RCT），共有68例预期寿命<6个月和临床相关压力水平（医院焦虑抑郁总分；HADStot≥8）的患者，包括他们的FCs被随机分配到DT，DT+(包括他们的FC)，或1:1:1比例的标准姑息治疗(SPC)。研究参与者被要求在干预前后完成一组问卷。
结果：合并组（DT和DT+）显示干预后患者的生活质量（FACIT-Pal14）显着提高（平均差6.15，SD=1.86，p<0.01）。我们发现了统计学上显著的逐组交互效应:而干预组患者的HADStot在术后前期保持稳定,对照组的HADStot增加（F=4.33，df=1，82.9；p<0.05），表明DT的保护作用。大多数患者和他们的FC发现DT有用，并将其推荐给他们情况下的其他人。
结论：DT干预已广受好评，并显示出增加HRQoL并防止进一步的心理健康恶化的潜力，绝症患者的疾病负担和痛苦。DT干预有可能成为促进绝症患者及其FC之间的临终对话的宝贵工具。然而,在姑息治疗环境中在RCT框架内实施DT带来了重大挑战.我们建议对DT进行稍微修改且资源密集程度较低的版本，以向绝症患者的FC提供DT清单，授权他们在他们所爱的人最后的日子里问对他们来说最重要的问题。
背景：本研究已在临床试验注册中心注册（ClinicalTrials.gov-ProtocolRecordNCT02646527；注册日期：2016年04月01日）。CONSORT2010指南用于正确报告如何进行随机试验。
方法：在这个多中心中，随机对照试验（RCT），共有68例预期寿命<6个月和临床相关压力水平（医院焦虑抑郁总分；HADStot≥8）的患者，包括他们的FCs被随机分配到DT，DT+(包括他们的FC)，或1:1:1比例的标准姑息治疗(SPC)。研究参与者被要求在干预前后完成一组问卷。
结果：合并组（DT和DT+）显示干预后患者的生活质量（FACIT-Pal14）显着提高（平均差6.15，SD=1.86，p<0.01）。我们发现了统计学上显著的逐组交互效应:而干预组患者的HADStot在术后前期保持稳定,对照组的HADStot增加（F=4.33，df=1，82.9；p<0.05），表明DT的保护作用。大多数患者和他们的FC发现DT有用，并将其推荐给他们情况下的其他人。
结论：DT干预已广受好评，并显示出增加HRQoL并防止进一步的心理健康恶化的潜力，绝症患者的疾病负担和痛苦。DT干预有可能成为促进绝症患者及其FC之间的临终对话的宝贵工具。然而,在姑息治疗环境中在RCT框架内实施DT带来了重大挑战.我们建议对DT进行稍微修改且资源密集程度较低的版本，以向绝症患者的FC提供DT清单，授权他们在他们所爱的人最后的日子里问对他们来说最重要的问题。
背景：本研究已在临床试验注册中心注册（ClinicalTrials.gov-ProtocolRecordNCT02646527；注册日期：2016年04月01日）。CONSORT2010指南用于正确报告如何进行随机试验。
