search
Back to results

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

Primary Purpose

Pancreatic Cancer

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Smart phone application(NOOM)
Non-user
Sponsored by
Yonsei University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Pancreatic Cancer

Eligibility Criteria

20 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Division of Gastroenterology, Department of Internal Medicine, Yonsei University College of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Smart phone application(NOOM)

Non-user

Arm Description

Outcomes

Primary Outcome Measures

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.
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).

Secondary Outcome Measures

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.

Full Information

First Posted
September 27, 2019
Last Updated
September 27, 2019
Sponsor
Yonsei University
search

1. Study Identification

Unique Protocol Identification Number
NCT04109495
Brief Title
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

2. Study Status

Record Verification Date
September 2019
Overall Recruitment Status
Completed
Study Start Date
February 22, 2017 (Actual)
Primary Completion Date
March 27, 2018 (Actual)
Study Completion Date
March 27, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yonsei University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatic Cancer

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Smart phone application(NOOM)
Arm Type
Other
Arm Title
Non-user
Arm Type
Other
Intervention Type
Other
Intervention Name(s)
Smart phone application(NOOM)
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Non-user
Intervention Description
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.
Primary Outcome Measure Information:
Title
PG-SGA(Patient-Generated Subjective Global Assessment)
Description
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.
Time Frame
12 weeks
Title
EORTC Questionnaires - Quality of Life
Description
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).
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Skeletal muscle index change
Description
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.
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 1) Among patients with pancreatic cancer who visited Severance Hospital of Yonsei University Patients who received the explanation from the investigator and agreed to the written consent of the subject 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: Those who have or had a history of abdominal surgery within the past 1 year Those who have an acute illness (pneumonia, sepsis, shock, etc.) and have an infection at the time of registration chronic liver disease and chronic obstructive pulmonary disease Patients with nutrient absorption disorder due to gastrointestinal mucosal diseases (ulcerative colitis, Crohn's disease, acute and chronic diarrhea, etc.) Severe disease patients (heart failure, liver failure, kidney failure and hemodialysis, etc.) Those who are pregnant or breastfeeding Those who have used steroids within the last one month Patients diagnosed of peritoneal seeding or suspected GI obstructive sign Those who are already taking nutritional supplements
Facility Information:
Facility Name
Division of Gastroenterology, Department of Internal Medicine, Yonsei University College of Medicine
City
Seoul
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
34463630
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.
Results Reference
derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs