Clinical trial NCT04109495: Usefulness of Smartphone Application for Improving Nutritional Status of Pancreatic Cancer Patients
Official title: Usefulness of Smartphone Application for Improving Nutritional Status of Pancreatic Cancer Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pancreatic Cancer
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2019-09-30
Enrollment: 40
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a prospective cohort study designed to investigate the usefulness of the Noom smartphone application on nutrition management of pancreatic cancer patients. We randomly assigned patients with first diagnosed pancreatic cancer to Noom user group or non-Noom user group. A total of 40 participants were included for randomization. All patients underwent nutritional assessments (PG-SGA), laboratory test and quality of life assessments (EORTC QLQ) at enrollment, 4, 8, and 12 weeks. During study period, Noom user group voluntarily record meals and get feedback.
Primary purpose: OTHER

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.


Eligibility criteria: 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

Primary outcomes:
measure: PG-SGA(Patient-Generated Subjective Global Assessment)
timeFrame: 12 weeks
measure: EORTC Questionnaires - Quality of Life
timeFrame: 12 weeks
Secondary outcomes:
measure: Skeletal muscle index change
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Division of Gastroenterology, Department of Internal Medicine, Yonsei University College of Medicine
Study officials:
References:
citation: 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.