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.

Conditions

• Pancreatic Cancer

Interventions

BEHAVIORAL

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.

BEHAVIORAL

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.

BEHAVIORAL

Educational Handouts

Participants will receive educational handouts on diet.

BEHAVIORAL

NutritionCoaching

Participants will receive bi-weekly nutrition coaching on anti-inflammatory dietary patterns and foods.

BEHAVIORAL

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.

BEHAVIORAL

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.

BEHAVIORAL

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.

Sponsors & Collaborators

• H. Lee Moffitt Cancer Center and Research Institute

  lead OTHER

Principal Investigators

• Sylvia Crowder, PhD · Moffitt Cancer Center

• Pamela Hodul, MD · Moffitt Cancer Center

Study Design

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-09-12

Primary Completion

2025-01-17

Completion

2026-06-30

Countries

• United States

Study Locations