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Background <p>Nudge strategies are well-established in behavioral economics as effective approaches for promoting desirable behaviors. However, the potential benefits of integrating nudge-based strategies into pharmacist-led patient education have not yet been demonstrated. Here, we present a study protocol for an interventional trial to address this issue.</p> Methods <p>The PHARM-NUDGE study is a multicenter, randomized, parallel-group, single-blind, controlled trial prospectively designed to evaluate whether nudge-based pharmacist-led education can promote patients’ preventive behaviors against skin toxicities associated with cancer chemotherapy. The key inclusion criteria are as follows: (1) patients who are men or women and aged 18 years or older and (2) patients scheduled to receive a chemotherapy regimen containing capecitabine, liposomal doxorubicin, lenvatinib, cetuximab, or panitumumab in outpatient chemotherapy units or during hospitalization. The enrolled patients are randomly assigned in a 2:1 ratio to the nudge-based education or standard education groups. Pharmacists responsible for patient education utilize special educational tools that incorporate nudge strategies and provide skincare education to patients assigned to the nudge-based education group. Patients assigned to the standard education group receive skincare education with equivalent content but without nudges. The primary endpoint is the proportion of patients in each group who achieve four or more of the five predefined behavioral criteria.</p> Conclusions <p>The PHARM-NUDGE study is the first randomized controlled trial to evaluate the potential benefits of integrating nudge strategies into pharmacist-led skincare education for patients undergoing cancer chemotherapy with a high risk of skin toxicity, with patient enrollment initiated on October 15, 2025. Completion of the trial and acquisition of the final results are eagerly anticipated.</p> Trial registration <p>This trial was registeredwith the Japan Registry of Clinical Trials (clinical trial number: jRCT1040250089, registration date: September 3, 2025).</p>

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Nudge-based patient education by pharmacists to promote self-care behaviors for preventing and mitigating chemotherapy-induced skin toxicity: rationale, design, and study protocol of the PHARM-NUDGE trial

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2026年2月21日

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  • Yuka Ito,
  • Koji Suzuki,
  • Masahiro Hatori,
  • Takahiko Yagi,
  • Yasunori Miyamoto,
  • Hikaru Sato,
  • Shuichi Watabe,
  • Naoki Shibata,
  • Yume Otsuka,
  • Tatsuya Yagi,
  • Junichi Kawakami

摘要

Background

Nudge strategies are well-established in behavioral economics as effective approaches for promoting desirable behaviors. However, the potential benefits of integrating nudge-based strategies into pharmacist-led patient education have not yet been demonstrated. Here, we present a study protocol for an interventional trial to address this issue.

Methods

The PHARM-NUDGE study is a multicenter, randomized, parallel-group, single-blind, controlled trial prospectively designed to evaluate whether nudge-based pharmacist-led education can promote patients’ preventive behaviors against skin toxicities associated with cancer chemotherapy. The key inclusion criteria are as follows: (1) patients who are men or women and aged 18 years or older and (2) patients scheduled to receive a chemotherapy regimen containing capecitabine, liposomal doxorubicin, lenvatinib, cetuximab, or panitumumab in outpatient chemotherapy units or during hospitalization. The enrolled patients are randomly assigned in a 2:1 ratio to the nudge-based education or standard education groups. Pharmacists responsible for patient education utilize special educational tools that incorporate nudge strategies and provide skincare education to patients assigned to the nudge-based education group. Patients assigned to the standard education group receive skincare education with equivalent content but without nudges. The primary endpoint is the proportion of patients in each group who achieve four or more of the five predefined behavioral criteria.

Conclusions

The PHARM-NUDGE study is the first randomized controlled trial to evaluate the potential benefits of integrating nudge strategies into pharmacist-led skincare education for patients undergoing cancer chemotherapy with a high risk of skin toxicity, with patient enrollment initiated on October 15, 2025. Completion of the trial and acquisition of the final results are eagerly anticipated.

Trial registration

This trial was registeredwith the Japan Registry of Clinical Trials (clinical trial number: jRCT1040250089, registration date: September 3, 2025).