The MONITOR Study: Remote Monitoring Of a Nutrition Intervention To Optimize Treatment Response
NCT ID: NCT06050395
Last Updated: 2025-09-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
40 participants
INTERVENTIONAL
2023-09-12
2026-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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MONITOR group: Monitoring of a Nutrition Intervention to Optimize treatment Response
Participants randomized to the MONITOR arm will be provided dietary coaching biweekly to discuss nutrition concerns, anti-inflammatory diet compliance, and set SMART goals based on their most recent Vioscreen food frequency questionnaires.
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.
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.
Standard Usual Care
Standard Usual Care participants will receive usual nutrition care received in the Moffitt Cancer Center pancreatic clinic, in addition to handouts on diet.
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.
Educational Handouts
Participants will receive educational handouts on diet.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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H. Lee Moffitt Cancer Center and Research Institute
OTHER
Responsible Party
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Principal Investigators
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Sylvia Crowder, PhD
Role: PRINCIPAL_INVESTIGATOR
Moffitt Cancer Center
Pamela Hodul, MD
Role: PRINCIPAL_INVESTIGATOR
Moffitt Cancer Center
Locations
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Moffitt Cancer Center
Tampa, Florida, United States
Countries
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Other Identifiers
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MCC-22523
Identifier Type: -
Identifier Source: org_study_id
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