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

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.

Study Overview

• Status: Recruiting
• Conditions: Pancreatic Cancer
• Intervention / Treatment: Behavioral: Quality fo Life Questionnaire (FHSI); Behavioral: Vioscreen Food Frequency Questionnaire (FFQ); Behavioral: NutritionCoaching; Behavioral: Follow-Up Survey; Behavioral: Functional Assessment of Anorexia/Cachexia Treatment (FAACT) Questionnaire; Behavioral: Patient Reported Outcomes Measure- Cognitive Function (PROMIS-Cog) Questionnaire; Behavioral: Educational Handouts

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Tampa, Florida, United States, 33612
      • Recruiting
      • Moffitt Cancer Center
      • Principal Investigator: Pamela Hodul, MD
      • Sub-Investigator: Kea Turner, PhD, MPH, MA
      • Contact: Crystal Bryant, MPH; Phone Number: 813-745-2168; Email: Crystal.Bryant@moffitt.org
      • Principal Investigator: Sylvia Crowder, PhD
      • Sub-Investigator: Heather Jim, PhD
      • Sub-Investigator: Laurence Gore, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	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: 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.
Active Comparator: 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.	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: 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.; Behavioral: Educational Handouts; Participants will receive educational handouts on diet.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Recruitment Rate -Feasibility	The study will be deemed feasible if >/= 60% of eligible participants are enrolled	Up to 8 months
Retention Rate - Feasibility	The study will be deemed feasible if >/=70% of participants complete the post-intervention questionnaire	at 12 weeks
Adherence - Feasibility	The study will be deemed feasible if average attendance is >/=4 weeks of sessions (out of 6) for MONITOR arm	at 12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Participant Satisfaction with Overall Program- Acceptability	The study will be deemed acceptable based on the satisfaction score on follow-up survey. The follow-up survey uses open-ended and likert-style questions regarding 1) relevance and applicability of the MONITOR intervention content and objective/subjective data collection methods; 2) intervention length and timing; and 3) barriers/facilitators to participation and retention. On a 5-point Lkert-type scale, a(1) =strongly agree and e(5)=strongly disagree. Participant Satisfaction with Overall Program is determined by a score >/=3 on a 5-point scale.	at 12 weeks
Participant intent to continue using skills- Acceptability	The study will be deemed acceptable based on the satisfaction score on follow-up survey. The follow-up survey uses open-ended and likert-style questions regarding 1) relevance and applicability of the MONITOR intervention content and objective/subjective data collection methods; 2) intervention length and timing; and 3) barriers/facilitators to participation and retention. On a 5-point Lkert-type scale, a(1) =strongly agree and e(5)=strongly disagree. Participant intent to continue using skills- is determined by a score >/=3 on a 5-point scale.	at 12 weeks
Participant perception of utility of knowledge gained - Acceptability	The study will be deemed acceptable based on the satisfaction score on follow-up survey. The follow-up survey uses open-ended and likert-style questions regarding 1) relevance and applicability of the MONITOR intervention content and objective/subjective data collection methods; 2) intervention length and timing; and 3) barriers/facilitators to participation and retention. On a 5-point Lkert-type scale, a(1) =strongly agree and e(5)=strongly disagree. Participant perception of utility of knowledge gained is determined by a score >/=3 on a 5-point scale.	at 12 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Treatment Effect - Quality of Life	Quality of Life will be measured using the FACT-Hep questionnaire. Participants will take the Functional Assessment of Cancer Therapy Hepatobiliary Cancer Symptom 8 Item Version (FHSI) questionnaire which uses a 5-point likert-type scale, 0=not at all and 4=Very much. A lower total score indicates better quality of life.	at Baseline, and at 6 and 12 weeks

Collaborators and Investigators

• Sponsor: H. Lee Moffitt Cancer Center and Research Institute
• Investigators: Principal Investigator: Pamela Hodul, MD, Moffitt Cancer Center; Principal Investigator: Sylvia Crowder, PhD, Moffitt Cancer Center

Publications and helpful links

Helpful Links

• Moffitt Cancer Center Clinical Trials website

Study record dates

Study Major Dates

• Study Start (Actual): September 12, 2023
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: September 11, 2023
• First Submitted That Met QC Criteria: September 15, 2023
• First Posted (Actual): September 22, 2023

Study Record Updates

• Last Update Posted (Actual): February 14, 2024
• Last Update Submitted That Met QC Criteria: February 12, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: MCC-22523

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No