Clinical Trial 22523

• Overview

  Study Title:

  The MONITOR Study: Remote Monitoring Of a Nutrition Intervention To Optimize Treatment Response

  Summary:

  The purpose of the study is to evaluate the feasibility and acceptability of a remote nutrition coaching and monitoring intervention during the 12-weeks of active chemotherapy for borderline resectable and locally advanced pancreatic cancer participants.

  Objective:

  The goal of the current application is to evaluate the feasibility and acceptability of a remote nutrition coaching and monitoring intervention during the 12-weeks of active chemotherapy for borderline resectable and locally advanced PC patients called MONITOR: remote Monitoring Of a Nutrition Intervention To Optimize treatment Response. This data will inform the basis of a fully powered RCT to improve nutritional status, patient reported outcomes, and treatment outcomes in borderline resectable and locally advanced PC patients. Aim 1: Establish feasibility/acceptability/usability of the MONITOR intervention via a pilot RCT in borderline resectable and locally advanced PC patients. Approach: Recruit n=40 borderline resectable or locally advanced PC patients (n=20 MONITOR, n=20 Enhanced Usual Care). Goal: Evaluate a set of feasibility and acceptability benchmarks including: a) Feasibility: rates of recruitment b) Adherence: nutrition coaching session completion rate c) Acceptability/Usability: participant ratings of satisfaction with the intervention d) Sensitivity assessment (exploratory): body composition measures (lean muscle mass, skeletal muscle index, etc.), dietary change, and QOL at baseline (visit 1: pre-chemotherapy), ~6-weeks (visit 2: during chemotherapy), and ~12-weeks (visit 3: immediately following chemotherapy) to inform the future R01. Aim 2: Further revise and refine the MONITOR intervention. Approach: Based on data and open-ended survey responses in Aim 1, we will further refine and revise the intervention to best meet the unique needs and preferences of borderline resectable and locally advanced PC patients.

• Inclusion Criteria

  Inclusion Criteria:
  • Men or women 18 years of age or more
  • Newly diagnosed, in place tumors of the pancreas
  • No documented or observable psychiatric or neurological disorders that would interfere with study participation (e.g., dementia, psychosis)
  • Able to speak and read English
  • Able to consume food orally
  • Chemotherapy naive
  • Scheduled to receive treatment with chemotherapy
  • Able to provide verbal informed consent

• Exclusion Criteria

  Exclusion Criteria:
  • Women who are pregnant
  • Pancreatic cancer not the primary diagnosis
  • Patients on enteral or parental nutrition
  • Patients with metastatic pancreatic cancer
  • Patients with evidence of impeding bowel obstruction
  • Patients presenting with ascites

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