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The MONITOR Study: Remote Monitoring Of a Nutrition Intervention To Optimize Treatment Response
Sponsor: H. Lee Moffitt Cancer Center and Research Institute
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.
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
40
Start Date
2023-09-12
Completion Date
2026-06
Last Updated
2026-03-31
Healthy Volunteers
No
Conditions
Interventions
Quality fo Life Questionnaire (FHSI)
Participants will take a survey at baseline and visit 2 (weeks 6-8), and visit 3 (week 10-14). The Functional Assessment of Cancer Therapy Hepatobiliary Cancer Symptom Index-8 (FHSI) questionnaire uses a 5-point Likert-type scale, 0=not at all and 4=Very much. A lower total score indicates better quality of life.
Vioscreen Food Frequency Questionnaire (FFQ)
Participants will receive a web-based link and information to complete VioScreen, a web-based food frequency questionnaire, which allows participants to choose the average frequency of consumption of food items over a given time frame (1 month, 3 month, 1 year, etc.) on a Likert scale with choices ranging by individual questions. Total energy and nutrient intake is estimated by summing intakes from each food based on the selected portion size, reported frequency of consumption, and nutrient content of each food item. Anti-inflammatory and pro-inflammatory dietary patterns are calculated using the energy-adjusted dietary inflammatory index (DII) score to represent the inflammatory potential of an individual's overall diet, using data from FFQ responses. Higher DII scores represent more pro-inflammatory diets while lower (i.e., more negative) DII scores represent more anti-inflammatory diet.
Educational Handouts
Participants will receive educational handouts on diet.
NutritionCoaching
Participants will receive bi-weekly nutrition coaching on anti-inflammatory dietary patterns and foods.
Follow-Up Survey
Participants will complete a custom exit/follow up survey regarding relevance, acceptability, intervention length and timing, an barriers/facilitators. This survey contains 38 questions scored from 1 -Strongly agree to 5-Strongly disagree. A lower score indicates patient satisfaction with the program and the skills and knowledge gained in the program.
Functional Assessment of Anorexia/Cachexia Treatment (FAACT) Questionnaire
The FAACT questionnaire uses a 5 point Likert-type scale, 0=Not at all, 4=Very much. A higher score indicates better appetite and quality of life.
Patient Reported Outcomes Measure- Cognitive Function (PROMIS-Cog) Questionnaire
Participants will complete the PROMIS-Cog form which measures self-reported cognitive deficits. The questionnaire uses a 5 point Likert-type scale, 1=Very often and 5=Never. A higher score indicates higher cognitive function.
Locations (1)
Moffitt Cancer Center
Tampa, Florida, United States