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Feasibility trial of STRONG: A digital intervention to improve nutritional management among gastrointestinal cancer patients with peritoneal disease receiving CRS-HIPEC
ABSTRACT
Background:
Cytoreductive surgery combined with hyperthermic intraperitoneal chemotherapy (CRS-HIPEC) improves survival outcomes for gastrointestinal (GI) cancer patients with peritoneal disease (PD). This patient population is at high risk of malnutrition and CRS-HIPEC can further negatively impact patients’ nutritional statuses. However, there has been limited testing of nutritional interventions for this patient population.
Objective:
The goal of this study was to test the feasibility, acceptability, and usability of Support Through Remote Observation and Nutrition Guidance (STRONG), a multilevel digital health intervention to improve nutritional management among GI cancer patients with PD receiving CRS-HIPEC. Individualized and remote monitoring of patients’ food intake can bridge the gap between the clinical need for in-person patient follow up and the substantial barriers for this patient population to access nutritional support.
Methods:
STRONG is a 12-week digital intervention in which participants received biweekly nutritional counseling with a dietitian, logged food intake using a Fitbit tracker, and reported nutrition-related outcomes. Dietitians received access to a web-based dashboard and remotely monitored patients’ reported food intake and nutrition-impact symptoms. Feasibility, acceptability, and usability of the intervention were assessed against a priori benchmarks.
Results:
Participants (N=10) had a median age of 57.5 years (range: 24-79). Feasibility benchmarks were achieved for recruitment (59%), study assessment completion (90%), dietitian appointment attendance (70%), daily food intake logging adherence (60%), and participant retention (100%). Most participants rated the intervention as acceptable (80%) and reported a high level of usability for dietetic services (100%). The benchmark usability for the Fitbit tracker to log food intake was not met.
Conclusions:
The STRONG intervention overall demonstrated to be feasible, acceptable, and usable among GI cancer patients with PD receiving CRS-HIPEC. A fully-powered randomized controlled trial in more diverse patient populations and settings is needed to test the efficacy of STRONG for reducing malnutrition and improving patient outcomes. Clinical Trial: The Support Through Remote Observation and Nutrition Guidance (STRONG) intervention for gastrointestinal cancer patients with peritoneal disease study was registered on clinicaltrials.gov (NCT05649969) in December 2022 prior to participant enrollment.
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