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NCT Number: NCT06050395

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Moffitt Cancer Center

Tampa, Florida, 33612, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Educational Handouts

Behavioral

Participants will receive educational handouts on diet.

NutritionCoaching

Behavioral

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

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.

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.

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.

Primary outcomes

  1. Recruitment Rate -Feasibility

    Time frame: Up to 8 months

    The study will be deemed feasible if >/= 60% of eligible participants are enrolled

  2. Retention Rate - Feasibility

    Time frame: at 12 weeks

    The study will be deemed feasible if >/=70% of participants complete the post-intervention questionnaire

  3. Adherence - Feasibility

    Time frame: at 12 weeks

    The study will be deemed feasible if average attendance is >/=4 weeks of sessions (out of 6) for MONITOR arm

Secondary outcomes

  1. Participant Satisfaction with Overall Program- Acceptability

    Time frame: at 12 weeks

    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.

  2. Participant intent to continue using skills- Acceptability

    Time frame: at 12 weeks

    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.

  3. Participant perception of utility of knowledge gained - Acceptability

    Time frame: at 12 weeks

    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.

Other outcomes

  1. Treatment Effect - Quality of Life

    Time frame: at Baseline, and at 6 and 12 weeks

    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.

Sponsors and collaborators

Lead sponsor

H. Lee Moffitt Cancer Center and Research Institute

Other

Registry information

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Sep 22, 2023
Registry last updated
Jun 26, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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