Malnutrition Screening and Dietary Intervention to Improve Nutrition Outcomes in Patients With Unresectable Pancreatic Cancer

Study Overview
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Brief Summary
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This clinical trial compares the effect of malnutrition screening and dietary intervention to standard nutrition care on patients with pancreatic cancer that cannot be removed by surgery (unresectable). Fewer than 20% of patients diagnosed with unresectable pancreatic cancer do not survive one year after diagnosis so treatment often focuses on improving quality of life. Many patients experience increasing pain, nausea, vomiting, loss of appetite, weight loss and weakness. Behavioral interventions use techniques to help patients change the way they react to environmental triggers that may cause a negative reaction. Screening for inadequate nutrition (malnutrition) and providing weekly nutritional support may be effective methods to improve nutritional status and improve overall quality of life for patients with unresectable pancreatic cancer.

Detailed Description
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PRIMARY OBJECTIVES: I. To compare the quality of life of subjects after 12 weeks between the intervention group with nutrition optimization with dietary prescription and nutrition support in comparison to standard care. II. To compare the frequency of hospitalization and length of stay (LOS) after 12 weeks between the intervention group with nutrition optimization with dietary prescription and nutrition support in comparison to standard care. III. To compare the subject's functional status, body weight and dietary intake after 12 weeks between the intervention group with nutrition optimization with dietary prescription and nutrition support in comparison to standard care. OUTLINE: Patients are randomized to 1 of 2 arms. ARM I: Patients receive standard nutrition care and record dietary intake and physical activity using Myfitness Pal smartphone application on study. ARM II: Patients undergo malnutrition screening with a registered dietician at baseline and participate in 12 weekly nutrition support sessions and those at moderate to high risk for malnutrition receive a personalized diet prescription on study. Patients also record dietary intake and physical activity using Myfitness Pal smartphone application on study.

Official Title
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Malnutrition Screening and Nutrition Optimization to Improve Outcomes in Patients With Unresectable Pancreatic Cancer

Conditions
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Stage III Pancreatic Cancer American Joint Committee on Cancer (AJCC) v8, Stage IV Pancreatic Cancer AJCC v8, Unresectable Pancreatic Adenocarcinoma

Intervention / Treatment
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* Other: Best Practice
* Other: Dietary Intervention
* Other: Medical Chart Review
* Other: Medical Device Usage and Evaluation
* Other: Nutritional Assessment
* Other: Questionnaire Administration


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Unresectable pancreatic adenocarcinoma, receiving either 1) no chemotherapy, 2) 1st cycle of chemotherapy, or 3) greater than 1 cycle of chemotherapy if the patient's prognosis is greater than 6 months as determined by oncology collaborators Life expectancy of greater than 3 months and a Karnofsky performance score of 60 or more Adults >= 18 years old male or female Exclusion Criteria: Ascites requiring paracentesis for symptom improvement Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) values greater than 5 times the upper limit of normal Creatinine value greater than 2.0 for men and 1.5 for women Uncontrolled pain Uncontrolled nausea and vomiting

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 |
| --- | --- |
| Active Comparator: ARM I (Standard of care)<br>Patients receive standard nutrition care and record dietary intake and physical activity using Myfitness Pal smartphone application on study. | Other: Best Practice<br>* Receive standard nutrition care<br>* Other names: standard therapy;Other: Medical Chart Review<br>* Ancillary studies<br>* Other names: Chart Review;Other: Medical Device Usage and Evaluation<br>* Record dietary and physical activity using MyFitnessPal smartphone app<br>Other: Questionnaire Administration<br>* Ancillary studies<br>|
| Experimental: ARM II (Dietary intervention)<br>Patients undergo malnutrition screening with a registered dietician at baseline and participate in 12 weekly nutrition support sessions and those at moderate to high risk for malnutrition receive a personalized diet prescription on study. Patients also record dietary intake and physical activity using Myfitness Pal smartphone application on study. | Other: Dietary Intervention<br>* Participate in weekly support sessions with diet prescription<br>* Other names: Nutritional Interventions;Other: Medical Chart Review<br>* Ancillary studies<br>* Other names: Chart Review;Other: Medical Device Usage and Evaluation<br>* Record dietary and physical activity using MyFitnessPal smartphone app<br>Other: Nutritional Assessment<br>* Undergo malnutrition screening<br>* Other names: nutritional counseling;Other: Questionnaire Administration<br>* Ancillary studies<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life | Measured using short form 36. A two-sample t-test comparing changes from baseline in each of the outcomes between study arms used to estimate power | After 12 weeks | 
| Frequency of hospitalizations | Hospitalization defined as any stay in the hospital > 24 hours. A two-sample t-test comparing changes from baseline in each of the outcomes between study arms used to estimate power | After 12 weeks | 
| Length of hospital stay | Length of stay determined by the number of days of hospitalization including the date of admission and not including the day of discharge from the hospital. A two-sample t-test comparing changes from baseline in each of the outcomes between study arms used to estimate power | After 12 weeks | 
| Functional status using Karnofsky performance score | All activity recorded using MyfitnessPal. A two-sample t-test comparing changes from baseline in each of the outcomes between study arms used to estimate power | After 12 weeks | 
| Percent change in body weight | Collected from patient medical record. A two-sample t-test comparing changes from baseline in each of the outcomes between study arms used to estimate power | Baseline to after 12 weeks | 
| Average daily steps | Daily steps recorded using MyfitnessPal. A two-sample t-test comparing changes from baseline in each of the outcomes between study arms used to estimate power | After 12 weeks | 
| Calorie intake from Myfitness Pal | Food intake collected every 4 weeks and uploaded into patients medical record via patient portal. A two-sample t-test comparing changes from baseline in each of the outcomes between study arms used to estimate power | After 12 weeks |