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

## TL;DR

This study tests a patient-centered approach to improve nutrition care for esophageal and gastric cancer patients before surgery.

## Contribution

The study introduces a patient-mediated implementation strategy called STRONG to enhance nutrition care delivery in oncology.

## Key findings

- The STRONG strategy includes an electronic health record order set, a web-based dashboard, and a question prompt list.
- The pilot trial will assess feasibility and acceptability of the STRONG strategy in a real-world clinical setting.
- The study will collect preliminary data to support a future definitive trial on nutrition care delivery.

## Abstract

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.

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.

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.

ClinicalTrials.gov NCT06497569. Registered on July 11, 2024, prior to participant enrollment.

Patient-mediated implementation strategies aim to improve the delivery of healthcare through patient engagement and can affect patient outcomes and healthcare delivery

There has been limited study of patient-mediated implementation strategies in implementation science

Existing studies have focused on the impact of patient-mediated strategies on patient outcomes and not examined implementation or service delivery outcomes

This protocol outlines a pilot study of a patient-mediated implementation strategy to improve patient outcomes and nutrition care delivery in oncology

This line of research will lay the groundwork for a future definitive trial that evaluates the strategy’s effect on patient outcomes and nutrition care delivery