UNC Lineberger Comprehensive Cancer Center
This single-center pilot randomized controlled trial evaluates the feasibility, acceptability, and preliminary effects of STRONG, a digital nutrition support app delivered alongside remote dietitian-led nutrition counseling, in adults with pancreatic ductal adenocarcinoma initiating systemic therapy and/or radiation therapy. Approximately 80 participants will be randomized 1:1 to receive nutrition counseling plus either the STRONG app or printed nutrition education materials. Outcomes include feasibility, acceptability, nutritional status, quality of life, healthcare utilization, treatment delivery, caregiver outcomes, and survival. Findings will inform the design of a future trial evaluating whether app-based, tailored nutrition support improves outcomes compared with traditional nutrition education.
In order to participate in this study a subject must meet all of the eligibility criteria outlined below. Patients Participants Inclusion Criteria: * Written informed consent obtained to participate in the study and HIPAA authorization for release of personal health information. * Subjects is willing and able to comply with study procedures based on the judgement of the investigator or protocol designee. * Age ≥ 18 years at the time of consent. * Diagnosis of pancreatic ductal adenocarcinoma * Has initiated or scheduled to initiate systemic therapy and/or radiation therapy within 30 days of…
STRONG intervention app to support nutrition-related education, self-management, and engagement between counseling visits approximately 3 months.
individualized remote dietitian visits consisting of one initial visit and two remote follow-up visits over approximately 3 months. In addition, participants will receive printed nutrition education materials to support nutrition education and self-management during the intervention period.
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