A patient-mediated strategy to improve nutrition care after transition from hospital to home for pancreatic cancer surgery: a pilot randomised controlled trial study protocol

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INTRODUCTION: Nutrition counselling is recommended after pancreatic cancer surgery given the complex nutritional problems patients experience. In practice, access and delivery of nutrition counselling after pancreatic surgery varies across settings. To address this gap, our study team developed the Support Through Remote Observation and Nutrition Guidance (STRONG) programme, an implementation strategy that addresses common barriers to nutrition care delivery in oncology. METHODS AND ANALYSIS: The STRONG programme includes a standardised protocol to specify the timing and amount of nutrition counselling that should be delivered and patient-mediated implementation strategies including collection of patient-reported information, an educational brochure summarising common nutrition problems and recommended dietary strategies after pancreatic surgery and a question prompt list for the patient-dietitian encounter. A pilot randomised controlled trial will be conducted to assess the feasibility and acceptability of the STRONG programme compared with usual care in pancreatic cancer surgery patients after hospital discharge (n = 80). The trial is designed to be pragmatic and integrated into existing workflows and clinic teams. The primary goal will be to compare feasibility and acceptability outcomes against pre-planned benchmarks. Data will be collected from patients and caregivers and healthcare providers who assist with STRONG implementation. Secondary goals include collecting preliminary data on effectiveness and implementation outcomes that will support a future definitive hybrid implementation-effectiveness trial. ETHICS AND DISSEMINATION: This study was approved by the Moffitt Cancer Center Institutional Review Board of Record, Advarra (Pro00071143). Participants will be required to provide written consent prior to enrolment. Study findings will be disseminated through plain language summaries, conference abstracts and peer-reviewed publications. TRIAL REGISTRATION NUMBER: ClinicalTrials.gov NCT06001268. Registered on 21 August 2023, prior to participant enrolment.

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