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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2023-01097 | Registry Identifier | CTRP (Clinical Trial Reporting Program) |
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| Name | Class |
|---|---|
| Silicon Valley Community Foundation | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ARM I (Standard of care) | Active Comparator | Patients receive standard nutrition care and record dietary intake and physical activity using Myfitness Pal smartphone application on study. |
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| ARM II (Dietary intervention) | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Best Practice | Other | Receive standard nutrition care |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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 | 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. | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| ZhaoPing Li | UCLA / Jonsson Comprehensive Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UCLA / Jonsson Comprehensive Cancer Center | Los Angeles | California | 90095 | United States |
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| Dietary Intervention | Other | Participate in weekly support sessions with diet prescription |
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| Medical Chart Review | Other | Ancillary studies |
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| Medical Device Usage and Evaluation | Other | Record dietary and physical activity using MyFitnessPal smartphone app |
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| Nutritional Assessment | Other | Undergo malnutrition screening |
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| Questionnaire Administration | Other | Ancillary studies |
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| 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 |
| ID | Term |
|---|---|
| D010190 | Pancreatic Neoplasms |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
| D004066 | Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D017410 | Practice Guidelines as Topic |
| D059039 | Standard of Care |
| D004035 | Diet Therapy |
| D015596 | Nutrition Assessment |
| ID | Term |
|---|---|
| D017408 | Guidelines as Topic |
| D011785 | Quality Assurance, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
| D019984 | Quality Indicators, Health Care |
| D044623 | Nutrition Therapy |
| D013812 | Therapeutics |
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
| D015991 | Epidemiologic Measurements |
| D011634 | Public Health |
| D004778 | Environment and Public Health |
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