A patient-mediated implementation strategy to improve nutrition care delivery for esophageal and gastric cancer: a study protocol for a pilot randomized controlled trial

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BACKGROUND: Nutrition counseling before gastrointestinal surgery can improve patients’ quality of life, treatment tolerance, and surgical recovery. Nutrition counseling is especially important for individuals diagnosed with esophageal and gastric cancer, who are at high risk of malnutrition. Despite the increased risk for malnutrition, less than half of individuals diagnosed with esophageal and gastric cancer receive nutrition counseling before surgery. To address this practice gap, the Support through Remote Observation and Nutrition Guidance (STRONG) implementation strategy was developed. METHODS: STRONG includes three theory-informed strategies: an electronic health record order set for a standardized protocol that specifies the timing and amount of nutrition counseling that should be received, collection and visualization of patient-reported nutrition information in a web-based dashboard, and a question prompt list for the patient-dietitian encounter. Patients (N = 80) will be 1:1 randomized to STRONG or implementation as usual in this pilot trial. The trial will be pragmatic in design and STRONG will be implemented with existing clinic teams and workflows. The study’s primary aim will be to assess feasibility and acceptability against pre-planned benchmarks and secondary aims include collecting preliminary data on effectiveness and implementation outcomes that will support a future definitive hybrid implementation-effectiveness trial. DISCUSSION: Pilot studies play a critical role in implementation research by ensuring that strategies and proposed study methods are feasible prior to conducting a definitive trial. Positive findings from this line of research could support definitive testing of a patient-mediated implementation strategy to improve nutrition care access and delivery for cancer patients at high risk of malnutrition. TRIAL REGISTRATION: ClinicalTrials.gov NCT06497569. Registered on July 11, 2024, prior to participant enrollment.

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