Malnutrition Screening and Nutrition Optimization to Improve Outcomes in Patients With Unresectable Pancreatic Cancer
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Quality of life measured comparing changes in outcomes between study arms
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
ARM I (Standard of care)
Patients receive standard nutrition care and record dietary intake and physical activity using Myfitness Pal smartphone application on study.
干预措施: Best Practice (Other)
ARM I (Standard of care)
Patients receive standard nutrition care and record dietary intake and physical activity using Myfitness Pal smartphone application on study.
干预措施: Medical Chart Review (Other)
ARM I (Standard of care)
Patients receive standard nutrition care and record dietary intake and physical activity using Myfitness Pal smartphone application on study.
干预措施: Medical Device Usage and Evaluation (Other)
ARM I (Standard of care)
Patients receive standard nutrition care and record dietary intake and physical activity using Myfitness Pal smartphone application on study.
干预措施: Questionnaire Administration (Other)
ARM II (Dietary intervention)
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.
干预措施: Dietary Intervention (Other)
ARM II (Dietary intervention)
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.
干预措施: Medical Chart Review (Other)
ARM II (Dietary intervention)
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.
干预措施: Medical Device Usage and Evaluation (Other)
ARM II (Dietary intervention)
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.
干预措施: Nutritional Assessment (Other)
ARM II (Dietary intervention)
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.
干预措施: Questionnaire Administration (Other)
结局指标
主要结局
Quality of life measured comparing changes in outcomes between study arms
时间窗: After 12 weeks
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
Frequency of hospitalizations
时间窗: After 12 weeks
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
Length of hospital stay
时间窗: After 12 weeks
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
Functional status using Karnofsky performance score
时间窗: After 12 weeks
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.
Average daily steps
时间窗: After 12 weeks
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
Percent change in body weight
时间窗: Baseline to after 12 weeks
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
Calorie intake from Myfitness Pal
时间窗: After 12 weeks
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
次要结局
未报告次要终点