Abstract
BACKGROUND: Cytoreductive surgery combined with hyperthermic intraperitoneal chemotherapy (CRS-HIPEC) can improve survival outcomes for individuals with gastrointestinal (GI) cancer and peritoneal disease (PD). Individuals with GI cancer and PD receiving CRS-HIPEC are at increased risk for malnutrition. Despite the increased risk for malnutrition, there has been limited study of nutritional interventions for individuals receiving CRS-HIPEC. OBJECTIVE: We aimed 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 individuals with GI cancer and PD receiving CRS-HIPEC. We also assessed patient-reported outcomes, including malnutrition risk, health-related quality of life, and weight-related measures. 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. Implementation outcomes were assessed against prespecified benchmarks consistent with benchmarks used in prior studies. Changes in patient-reported outcomes at baseline and follow-up were assessed using linear and ordered logistic regressions. RESULTS: Participants (N=10) had a median age of 57.5 (IQR 54-69) years. Feasibility benchmarks were achieved for recruitment (10/17, 59% vs benchmark: 50%), study assessment completion (9/10, 90% vs benchmark: 60%), dietitian appointment attendance (7/10, 70% vs benchmark: 60%), daily food intake logging adherence (6/10, 60% vs benchmark: 60%), and participant retention (10/10, 100% vs benchmark: 60%). Most participants rated the intervention as acceptable (8/10, 80% vs benchmark: 70%) and reported a high level of usability for dietitian services (10/10, 100%). The benchmark usability for the Fitbit tracker to log food intake was not met. Compared to baseline, participants saw on average a 6.0 point reduction in malnutrition risk score (P=.01), a 20.5 point improvement in general health-related quality of life score (P=.002), and a 5.6 percentage point increase in 1-month weight change (P=.04) at the end of the study. CONCLUSIONS: The STRONG intervention demonstrated to be feasible, acceptable, and usable among individuals with GI cancer and PD receiving CRS-HIPEC. A fully powered randomized controlled trial is needed to test the effectiveness of STRONG for reducing malnutrition and improving patient outcomes.