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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
100
Receive standard nutrition care
Participate in weekly support sessions with diet prescription
Ancillary studies
Record dietary and physical activity using MyFitnessPal smartphone app
Undergo malnutrition screening
Ancillary studies
UCLA / Jonsson Comprehensive Cancer Center
Los Angeles, California, United States
Quality of life measured comparing changes in outcomes between study arms
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
Time frame: 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
Time frame: 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
Time frame: After 12 weeks
Functional status using Karnofsky performance score
The Karnofsky Performance Status (KPS) is a standardized measure used to assess a patient's ability to perform everyday tasks. It ranges from 0 to 100, with higher scores indicating better function.
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: After 12 weeks
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