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

Study Overview
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Brief Summary
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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.

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

Conditions
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Pancreatic Cancer

Intervention / Treatment
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* Behavioral: Quality fo Life Questionnaire (FHSI)
* Behavioral: Vioscreen Food Frequency Questionnaire (FFQ)
* Behavioral: Educational Handouts
* 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


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MONITOR group: Monitoring of a Nutrition Intervention to Optimize treatment Response<br>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)<br>* 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.<br>Behavioral: Vioscreen Food Frequency Questionnaire (FFQ)<br>* 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.<br>Behavioral: NutritionCoaching<br>* Participants will receive bi-weekly nutrition coaching on anti-inflammatory dietary patterns and foods.<br>Behavioral: Follow-Up Survey<br>* 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.<br>Behavioral: Functional Assessment of Anorexia/Cachexia Treatment (FAACT) Questionnaire<br>* 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.<br>Behavioral: Patient Reported Outcomes Measure- Cognitive Function (PROMIS-Cog) Questionnaire<br>* 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.<br>|
| Active Comparator: Standard Usual Care<br>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)<br>* 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.<br>Behavioral: Educational Handouts<br>* Participants will receive educational handouts on diet.<br>Behavioral: Follow-Up Survey<br>* 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.<br>Behavioral: Functional Assessment of Anorexia/Cachexia Treatment (FAACT) Questionnaire<br>* 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.<br>Behavioral: Patient Reported Outcomes Measure- Cognitive Function (PROMIS-Cog) Questionnaire<br>* 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.<br>|

What is the study measuring?
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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 |