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2017-02-22
2018-03-27
2018-03-27
40
NCT04109495
Yonsei University
Yonsei University
INTERVENTIONAL
Usefulness of Smartphone Application for Improving Nutritional Status of Pancreatic Cancer Patients
Malnutrition of hospitalized patients is reported in the range of 20-60% according to the definition and assessment method of malnutrition. 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.
N/A
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
| Study Registration Dates | Results Reporting Dates | Study Record Updates |
|---|---|---|
2019-09-27 | N/A | 2019-09-27 |
2019-09-27 | N/A | 2019-09-30 |
2019-09-30 | N/A | 2019-09 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
Other
Allocation:
Randomized
Interventional Model:
Parallel
Masking:
None
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
| OTHER: Smart phone application(NOOM) | OTHER: Smart phone application(NOOM)
|
| OTHER: Non-user | OTHER: Non-user
|
| Primary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| PG-SGA(Patient-Generated Subjective Global Assessment) | A patient-generated subjective global assessment (PG-SGA) for oncology patients has been developed by Ottery. This tool has two sections-a medical history section that is completed by the patient, and a physical assessment section that is completed by nursing, medical, or dietetic staff. The medical history section includes additional questions regarding the presence of oncology nutrition impact symptoms. | 12 weeks |
| EORTC Questionnaires - Quality of Life | The European Organization for Research and Treatment(EORTC) questionnaire was designed to measure cancer patients' physical, psychological and social functions. The questionnaire is composed of 5 multiitem scales (physical, role, social, emotional and cognitive functioning) and 9 single items(pain, fatigue, financial impact, appetite loss, nausea/vomiting, diarrhea, constipation, sleep disturbance and quality of life). | 12 weeks |
| Secondary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Skeletal muscle index change | Cross-sectional skeletal muscle area (SMA, cm2) at this level is highly correlated with total body skeletal muscle mass. Adjustment of SMA for height2 results in skeletal muscle index (SMI, cm2/m2), a measure for relative muscle mass. Using skeletal muscle index change we evaluated sarcopenia in pancreatic cancer patients. | 8 weeks |
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
20 Years
Accepts Healthy Volunteers:
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
