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Randomized Controlled Trial
. 2024 Dec;68(6):548-560.e2.
doi: 10.1016/j.jpainsymman.2024.08.037. Epub 2024 Sep 3.

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

Sayaka Takenouchi  1 , Yu Uneno  2 , Shigemi Matsumoto  3 , Ai Chikada  4 , Ryuji Uozumi  5 , Tomoko Izawa  6 , Sayako Ouchi  6 , Takako Kuroda  7 , Yu Hidaka  8 , Hitoshi Tanimukai  9 , Motoo Nomura  2 , Manabu Muto  10 , Keiko Tamura  11 , Satoru Tsuneto  4 , Yoshiyuki Kizawa  12 , Tatsuya Morita  13 , Masanori Mori  14
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Free article
Randomized Controlled Trial

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

Sayaka Takenouchi et al. J Pain Symptom Manage. 2024 Dec.
Free article

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.

Keywords: Advance care planning; advanced cancer; cultural adaptation; nurse-physician collaboration; shared decision-making.

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