Usefulness of Smartphone Application for Improving Nutritional Status of Pancreatic Cancer Patients
NCT ID: NCT04109495
Last Updated: 2019-09-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
40 participants
INTERVENTIONAL
2017-02-22
2018-03-27
Brief Summary
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In particular, the incidence of malnutrition in cancer patients is high up to 30-85%.
Gastrointestinal disease is related to the digestion and absorption of nutrition therefore malnutrition rate of those patients is relatively high. Careful management of nutrition support is needed.
Malnutrition causes dysfunction of the mesenteric membrane, immune function impairment, decreased function of major organs such as liver, kidney and heart and alteration in pharmacodynamics. It could also increase infection rate and complications of chemotherapy, delay recovery time, so that increase morbidity, mortality and length of hospital stay.
Proper nutrition management reduces malnutrition prevalence and medical costs of hospitalized patient, therefore nutrition screening and evaluation is necessary. The recent spread of smartphones has made it easier to record and evaluate meals, which are used in the diet market for weight loss through meal records and feedback based on smartphone applications. This approach is also expected to benefit patients with gastrointestinal cancer, where proper nutrition and feedback are important. In particular, pancreatic cancer, the worst intractable cancer of mankind, is digestive cancer with the most severe muscle mass reduction and nutritional deterioration after diagnosis.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
NONE
Study Groups
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Smart phone application(NOOM)
Smart phone application(NOOM)
The study population included first diagnosis of pancreatic cancer patients within 3 months of pancreatic cancer center visit, and randomly assigned to the use of Noom user group and non-use group. A total of 40 patients, 20 from each group, were used to examine nutritional status(PG-SGA), blood index analysis, and quality of life(EORTC QLQ) at 0, 4, 8, and 12 weeks. At the same time, the patients voluntarily record meals and receive feedback using Noom. The purpose and contents of this study are explained in detail to the subjects, and written consent is obtained. The questionnaire items included gender, age, weight, type of diagnosed digestive disease, treatment method, nutritional supplement, oral status and intake of oral supplement foods, and past medical history. To assess the nutritional status using laboratory data, blood(about 8ml) is collected for each visit.
Non-user
Non-user
The patients dose not use Noom application. A total of 40 patients, 20 from each group, were used to examine nutritional status (PG-SGA), blood index analysis, and quality of life (EORTC QLQ) at 0, 4, 8, and 12 weeks. The purpose and contents of this study are explained in detail to the subjects, and written consent is obtained. The questionnaire items included gender, age, weight, type of diagnosed digestive disease, treatment method, nutritional supplement, oral status and intake of oral supplement foods, and past medical history. To assess the nutritional status using laboratory data, blood (about 8ml) is collected for each visit. At each visit, you will be assessed nutritional status and quality of life through the PG-SGA and EORTC QLQ.
Interventions
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Smart phone application(NOOM)
The study population included first diagnosis of pancreatic cancer patients within 3 months of pancreatic cancer center visit, and randomly assigned to the use of Noom user group and non-use group. A total of 40 patients, 20 from each group, were used to examine nutritional status(PG-SGA), blood index analysis, and quality of life(EORTC QLQ) at 0, 4, 8, and 12 weeks. At the same time, the patients voluntarily record meals and receive feedback using Noom. The purpose and contents of this study are explained in detail to the subjects, and written consent is obtained. The questionnaire items included gender, age, weight, type of diagnosed digestive disease, treatment method, nutritional supplement, oral status and intake of oral supplement foods, and past medical history. To assess the nutritional status using laboratory data, blood(about 8ml) is collected for each visit.
Non-user
The patients dose not use Noom application. A total of 40 patients, 20 from each group, were used to examine nutritional status (PG-SGA), blood index analysis, and quality of life (EORTC QLQ) at 0, 4, 8, and 12 weeks. The purpose and contents of this study are explained in detail to the subjects, and written consent is obtained. The questionnaire items included gender, age, weight, type of diagnosed digestive disease, treatment method, nutritional supplement, oral status and intake of oral supplement foods, and past medical history. To assess the nutritional status using laboratory data, blood (about 8ml) is collected for each visit. At each visit, you will be assessed nutritional status and quality of life through the PG-SGA and EORTC QLQ.
Eligibility Criteria
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Inclusion Criteria
1. Patients who received the explanation from the investigator and agreed to the written consent of the subject
2. Men or Women aged 20 to 70
2\) First diagnosed with pancreatic cancer within 3 months 3) Patients scheduled to undergo first-line chemotherapy after the diagnosis of pancreatic cancer
Exclusion Criteria
2. Those who have an acute illness (pneumonia, sepsis, shock, etc.) and have an infection at the time of registration
3. chronic liver disease and chronic obstructive pulmonary disease
4. Patients with nutrient absorption disorder due to gastrointestinal mucosal diseases (ulcerative colitis, Crohn's disease, acute and chronic diarrhea, etc.)
5. Severe disease patients (heart failure, liver failure, kidney failure and hemodialysis, etc.)
6. Those who are pregnant or breastfeeding
7. Those who have used steroids within the last one month
8. Patients diagnosed of peritoneal seeding or suspected GI obstructive sign
9. Those who are already taking nutritional supplements
20 Years
70 Years
ALL
No
Sponsors
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Yonsei University
OTHER
Responsible Party
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Locations
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Division of Gastroenterology, Department of Internal Medicine, Yonsei University College of Medicine
Seoul, , South Korea
Countries
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References
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Keum J, Chung MJ, Kim Y, Ko H, Sung MJ, Jo JH, Park JY, Bang S, Park SW, Song SY, Lee HS. Usefulness of Smartphone Apps for Improving Nutritional Status of Pancreatic Cancer Patients: Randomized Controlled Trial. JMIR Mhealth Uhealth. 2021 Aug 31;9(8):e21088. doi: 10.2196/21088.
Other Identifiers
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1-2016-0061
Identifier Type: -
Identifier Source: org_study_id