Feasibility and acceptability of the MONITOR study: Remote monitoring of a nutrition intervention to optimize treatment response in pancreatic cancer patients.

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432 Background: Pancreatic cancer (PC) patients who can maintain weight before and during treatment have statistically significantly improved survival. However, weight maintenance is incredibly challenging as more than 80% of PC patients suffer from significant weight loss at diagnosis coupled with severe nutrition impact symptoms (NIS) that influence the ability and desire to eat (e.g., pain, anorexia, early satiety, nausea, vomiting, diarrhea/constipation). Despite significant weight concerns, there are limited interventions addressing nutrition coaching to enhance dietary quality and mitigate malnutrition. The aim of this pilot trial was to examine feasibility, acceptability, usability, and preliminary efficacy of a remote nutrition monitoring intervention in borderline resectable and locally advanced PC patients. Methods: PC patients scheduled to receive neoadjuvant chemotherapy were randomized 1:1 to 1) biweekly, remote-based personalized dietary coaching on the dietary inflammatory index (DII) during the initial 12 weeks of chemotherapy or 2) standard usual care. The DII is a scoring system that assesses the potential of a diet to cause inflammation ranging from 7 to -7, with higher scores representing a more pro-inflammatory diet (e.g., 7) while lower scores represent a more anti-inflammatory diet (e.g., -7). Participants also completed food frequency questionnaires, measures of body composition, and validated quality of life surveys. Study assessments were completed at baseline, 6, and 12-weeks. Results: Forty PC patients consented to the study (n=5 withdrew after being randomized to standard care, n=5 become ineligible after consent due to change in treatment, n=5 were lost to follow-up, n=1 died). Participants were primarily white (97%), male (57%), married (74%), and college graduates (62%). Average biweekly dietary coaching attendance was 73%. All participants agreed or strongly agreed that the dietary coaching sessions were relevant, they gained knowledge during the intervention, they liked the timing of the intervention (e.g., beginning before chemotherapy), were satisfied with the overall program, and planned to continue the intervention skills learned. Additionally, there was a statistically significant decrease in the DII score, representing a more anti-inflammatory dietary pattern, (estimate=-1.31, p=0.0025) at 12-weeks compared to baseline. Conclusions: This intervention was feasible and acceptable to PC patients. Preliminary efficacy data showed participants in the intervention arm who received coaching on the DII diet score significantly improved their overall diet quality. Future studies should examine intervention efficacy in a larger, randomized controlled trial.

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