Co-designing opioid stewardship guidelines for cancer pain management in Nepal: study protocol.

INTRODUCTION: Cancer pain remains inadequately managed in low-resource settings such as Nepal, where regulatory barriers, stigma, limited opioid availability, and insufficient clinical training hinder effective treatment. Although opioids are essential for moderate to severe cancer pain, concerns regarding misuse and weak system-level governance restrict rational access, contributing to avoidable suffering and health inequities. The Pilot Initiative for Local Opioid Treatment (PILOT) study aims to co-design, pilot, and evaluate a contextually appropriate opioid stewardship framework to strengthen cancer pain management in Nepal. METHODS: This multi-phase, participatory mixed-methods study comprises six phases. Phase I involves a systematic scoping review of opioid stewardship models in comparable low-resource settings. Phase II engages key stakeholders, including oncologists, pharmacists, nurses, palliative care providers, policymakers, patients, and caregivers, through focus group discussions (n = 40-50) and key informant interviews (n = 15-20) across urban and rural oncology settings in three provinces. Phase III is a three-round modified e-Delphi consensus process involving approximately 20-25 national and international experts, using anonymous, iterative feedback to systematically build consensus on guideline components. Phase IV convenes an in-person national guideline development workshop bringing together over 40 stakeholders to translate the consensus framework into operational recommendations. Phase V involves a 12-week pilot implementation across at least one and up to three cancer care facilities, with Kathmandu Cancer Center serving as the primary site. Primary outcomes include feasibility, acceptability, adoption, and fidelity of the stewardship guidelines. Phase VI involves iterative refinement of the guidelines based on pilot findings and preparation for national dissemination.