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基于文化适应性的 RN-MD 协作 SICP 的 ACP:晚期癌症患者的可行性 RCT。

Culturally Adapted RN-MD Collaborative SICP-Based ACP: Feasibility RCT in Advanced Cancer Patients.

机构信息

Human Health Sciences, Graduate School of Medicine, Kyoto University (S.T., A.C., T.K., S.T.), Kyoto, Japan.

Department of Clinical Oncology, Kyoto University Hospital (Y.U., M.N.), Kyoto, Japan.

出版信息

J Pain Symptom Manage. 2024 Dec;68(6):548-560.e2. doi: 10.1016/j.jpainsymman.2024.08.037. Epub 2024 Sep 3.

Abstract

CONTEXT

Cultural adaptation is essential for optimizing programs centered around autonomy, such as the Serious Illness Care Program (SICP), especially for populations valuing family-involved decision-making.

OBJECTIVES

We aimed to evaluate the feasibility and efficacy of a culturally adapted SICP-based nurse-physician collaborative Advance Care Planning (ACP) intervention tailored for patients with advanced cancer who prefer family-involved decision-making.

METHODS

Oncology nurses, extensively trained and closely collaborating with physicians, conducted structured discussions with patients in the intervention group. The culturally adapted SICP-based ACP intervention was supplemented with trust-building, family involvement, and understanding of patient values. Primary inclusion criteria included patients within six weeks of initiating first-line palliative chemotherapy. Primary endpoints were achieving a 70% completion rate and assessing spiritual well-being (FACIT-Sp) at six months. Secondary endpoints included anxiety (GAD-7), depression (PHQ-9), quality of life (QOL) (CoQoLo), and ACP progress (ACP Engagement Scale) at the same interval.

RESULTS

Forty-one patients (67.2%) completed the six-month follow-up, falling short of the targeted completion rate. The least-squares mean change from baseline in spiritual well-being at six months was 3.00 in the intervention group and -2.22 in the standard care group (difference, 5.22 points; 95% confidence interval, 1.38-9.06; P = 0.009). Similar superiority of the intervention was observed in QOL and ACP progress.

CONCLUSION

Despite not meeting the targeted completion rate, the intervention group demonstrated enhanced spiritual well-being, QOL, and ACP progress. Our findings suggest revisions to the intervention manual to improve feasibility and to progress to an efficacy-focused randomized controlled trial.

摘要

背景

文化适应对于优化以自主性为中心的项目至关重要,如严重疾病护理计划(SICP),特别是对于重视家庭参与决策的人群。

目的

我们旨在评估针对偏好家庭参与决策的晚期癌症患者,基于文化适应性 SICP 的护士-医师合作预立医疗照护计划(ACP)干预的可行性和效果。

方法

经过广泛培训并与医师密切合作的肿瘤护士在干预组中与患者进行了结构化讨论。基于文化适应性 SICP 的 ACP 干预措施补充了建立信任、家庭参与和了解患者价值观的内容。主要纳入标准包括在开始一线姑息化疗后六周内的患者。主要终点是达到 70%的完成率,并在六个月时评估精神健康状况(FACIT-Sp)。次要终点包括在同一时间间隔内评估焦虑(GAD-7)、抑郁(PHQ-9)、生活质量(CoQoLo)和 ACP 进展(ACP 参与量表)。

结果

41 名患者(67.2%)完成了六个月的随访,未达到目标完成率。干预组从基线到六个月时精神健康状况的最小二乘均数变化为 3.00,标准护理组为-2.22(差异为 5.22 分;95%置信区间为 1.38-9.06;P = 0.009)。在生活质量和 ACP 进展方面,干预组也表现出类似的优越性。

结论

尽管未达到目标完成率,但干预组显示出增强的精神健康状况、生活质量和 ACP 进展。我们的研究结果表明需要修订干预手册以提高可行性,并推进到以疗效为重点的随机对照试验。

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