Usefulness of Smartphone Application for Improving Nutritional Status of Pancreatic Cancer Patients

Not Applicable

Completed

• Conditions: Pancreatic Cancer
• Interventions: Other: Smart phone application(NOOM); Other: Non-user

• Registration Number: NCT04109495
• Lead Sponsor: Yonsei University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-02-22
• Primary Completion: 2018-03-27
• Study Completion: 2018-03-27
• Status Verified: 2019-09
• Study First Submitted: 2019-09-27
• Study First Submitted QC: 2019-09-27
• Last Update Submitted: 2019-09-27
• Study First Posted: 2019-09-30
• Last Update Posted: 2019-09-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

1. Among patients with pancreatic cancer who visited Severance Hospital of Yonsei University

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

1. Those who have or had a history of abdominal surgery within the past 1 year
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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Smart phone application(NOOM)	Smart phone application(NOOM)	-
Non-user	Non-user	-

Primary Outcome Measures

Name	Time	Method
PG-SGA(Patient-Generated Subjective Global Assessment)	12 weeks	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.
EORTC Questionnaires - Quality of Life	12 weeks	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).

Secondary Outcome Measures

Name	Time	Method
Skeletal muscle index change	8 weeks	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.

Trial Locations

Locations (1)

Division of Gastroenterology, Department of Internal Medicine, Yonsei University College of Medicine; 🇰🇷 Seoul, Korea, Republic of