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J Pain Symptom Manage · Dec 2024
Randomized Controlled TrialCulturally Adapted RN-MD Collaborative SICP-Based ACP: Feasibility RCT in Advanced Cancer Patients.
- 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, and Masanori Mori.
- Human Health Sciences, Graduate School of Medicine, Kyoto University (S.T., A.C., T.K., S.T.), Kyoto, Japan. Electronic address: takenouchi.sayaka.6u@kyoto-u.ac.jp.
- J Pain Symptom Manage. 2024 Dec 1; 68 (6): 548560.e2548-560.e2.
ContextCultural 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.ObjectivesWe 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.MethodsOncology 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.ResultsForty-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.ConclusionDespite 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.Copyright © 2024 The Authors. Published by Elsevier Inc. All rights reserved.
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