文化适应的RN-MD合作SICP基础的ACP：晚期癌症患者的可行性随机对照试验

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

JOURNAL OF PAIN AND SYMPTOM MANAGEMENT

影响因子:3.5

分区:医学2区 / 临床神经病学2区卫生保健与服务2区医学：内科2区

发表日期:2024 Dec

作者: Sayaka Takenouchi, Yu Uneno, Shigemi Matsumoto, Ai Chikada, Ryuji Uozumi, Tomoko Izawa, Sayako Ouchi, Takako Kuroda, Yu Hidaka, Hitoshi Tanimukai, Motoo Nomura, Manabu Muto, Keiko Tamura, Satoru Tsuneto, Yoshiyuki Kizawa, Tatsuya Morita, Masanori Mori

DOI: 10.1016/j.jpainsymman.2024.08.037

摘要

文化适应对于优化以自主权为中心的项目（如严重疾病护理计划（SICP））至关重要，尤其是针对重视家庭参与决策的群体。我们旨在评估一种文化适应的SICP基础的护理人员-医师合作提前护理计划（ACP）干预措施的可行性和有效性，针对偏好家庭参与决策的晚期癌症患者。经过充分培训并与医师密切合作的肿瘤护理人员与干预组患者进行了结构化讨论。该文化适应的SICP基础的ACP干预还增添了建立信任、家庭参与和理解患者价值观的内容。主要纳入标准包括接受第一线姑息化疗六周以内的患者。主要终点是实现70%的完成率，并在六个月时评估精神福祉（FACIT-Sp）。次要终点包括焦虑（GAD-7）、抑郁（PHQ-9）、生活质量（QOL）（CoQoLo）以及ACP进展（ACP Engagement Scale）。共有41名患者（占67.2%）完成了六个月随访，未达预设的完成率。六个月时，干预组的精神福祉变化的最小二乘均值为3.00，标准护理组为-2.22（差异5.22分；95%置信区间：1.38-9.06；P=0.009）。在生活质量和ACP进展方面也观察到干预的优势。尽管未达到预期的完成率，干预组在精神福祉、生活质量和ACP进展方面表现出改善。我们的研究结果建议对干预手册进行修订，以提高可行性，并推进一项以疗效为目标的随机对照试验。

Abstract

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.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.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.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.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.