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

NCT06050395 | Active Not Recruiting

• 1 other identifier: MCC-22523
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (3)

• Participant Satisfaction with Overall Program- Acceptability

  at 12 weeks

• Participant intent to continue using skills- Acceptability

  at 12 weeks

• Participant perception of utility of knowledge gained - Acceptability

  at 12 weeks

Other Outcomes (1)

• Treatment Effect - Quality of Life

  at Baseline, and at 6 and 12 weeks

Study Arms (2)

MONITOR group: Monitoring of a Nutrition Intervention to Optimize treatment Response

EXPERIMENTAL

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); 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

Standard Usual Care

ACTIVE COMPARATOR

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); Behavioral: Educational Handouts; Behavioral: Follow-Up Survey; Behavioral: Functional Assessment of Anorexia/Cachexia Treatment (FAACT) Questionnaire; Behavioral: Patient Reported Outcomes Measure- Cognitive Function (PROMIS-Cog) Questionnaire

Interventions

Vioscreen Food Frequency Questionnaire (FFQ) BEHAVIORAL

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.

MONITOR group: Monitoring of a Nutrition Intervention to Optimize treatment Response

Educational Handouts BEHAVIORAL

Participants will receive educational handouts on diet.

Standard Usual Care

NutritionCoaching BEHAVIORAL

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

MONITOR group: Monitoring of a Nutrition Intervention to Optimize treatment Response

Follow-Up Survey BEHAVIORAL

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.

MONITOR group: Monitoring of a Nutrition Intervention to Optimize treatment Response; Standard Usual Care

Functional Assessment of Anorexia/Cachexia Treatment (FAACT) Questionnaire BEHAVIORAL

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.

MONITOR group: Monitoring of a Nutrition Intervention to Optimize treatment Response; Standard Usual Care

Patient Reported Outcomes Measure- Cognitive Function (PROMIS-Cog) Questionnaire BEHAVIORAL

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.

MONITOR group: Monitoring of a Nutrition Intervention to Optimize treatment Response; Standard Usual Care

Quality fo Life Questionnaire (FHSI) BEHAVIORAL

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.

MONITOR group: Monitoring of a Nutrition Intervention to Optimize treatment Response; Standard Usual Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• H. Lee Moffitt Cancer Center and Research Institute: lead

Study Sites (1)

Moffitt Cancer Center

Tampa, Florida, 33612, United States

Location

Related Links

• Moffitt Cancer Center Clinical Trials website

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Sylvia Crowder, PhD

  Moffitt Cancer Center

  PRINCIPAL INVESTIGATOR

• Pamela Hodul, MD

  Moffitt Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 11, 2023
• First Posted: September 22, 2023
• Study Start: September 12, 2023
• Primary Completion: January 17, 2025
• Study Completion (Estimated): June 1, 2026
• Last Updated: March 31, 2026

Record last verified: 2026-03

Locations

US (1)