Gastric Cancer
Conditions
Keywords
Gastrectomy, postoperative care, nutrition, Digital health technology, Application
Brief summary
The objective of this pilot study is to evaluate the feasibility and efficacy of Rhexium Onco Nutrition, HDT-202 for post-operative care in patients who have undergone gastrectomy.
Detailed description
1. A total of 4 visits will be performed. 2. At the screening visit,subject's written informed consent, assessing the inclusion/exclusion criteria and assigning enrollment numbers to eligible subjects, demographic information taking, medical history/medication history taking, vital signs measuring, physical examination, height and body weight measuring, instructing how to install/use the investigational device, and administering quality of life questionnaires. 3. During the treatment period, a total of 3 visits will be performed. To evaluate feasibility and efficacy, the following procedures will be carried out: vital signs measuring, physical examination, nutrition assessment/consultation, evaluation of feasibility for 'subjects', evaluation of feasibility for 'investigators', and adverse events (AEs)/concomitant medications checking and collecting. 4. During the treatment period, telephone monitoring is conducted depending on the compliance of subjects.
Interventions
DEVICERhexium Onco Nutrition
The research devices in this study are classified into subject mobile application and investigator web portal with no invasive action on the human body
Sponsors
Seoul National University Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention model description
HDT-202(application)
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patient who voluntarily signs the informed consent form for this study 2. Age of ≥19 years old 3. Patient who has undergone therapeutic gastrectomy after a diagnosis of gastric cancer 4. Able to eat food orally after gastrectomy 5. Patient who possesses an Android OS based mobile device and is capable of using the investigational device.
Exclusion criteria
1. Other cancer or metastasis documented within 5 years prior to screening 2. Ongoing or planned enteral tube feeding or total parenteral nutrition 3. Other clinically significant medical or psychiatric findings based on which the individual is considered by the investigator to be ineligible 4. Individual who possesses a mobile device on which the application is unable to be installed and/or run normally for technical reasons 5. Individual who, in the opinion of the investigator, has difficulty understanding how to use the investigational device or is unlikely to comply with other study procedures
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Score of each domain of the 'feasibility assessment of the investigational device (application)' questionnaire for subjects | Week 2 (Visit 2) | higher scores mean a better outcome |
| Score of each domain of the 'feasibility assessment of the investigational device (website)' questionnaire for investigators | Week 6 (Visit 3) | higher scores mean a better outcome |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The investigational device(application) usage compliance by underlying disease | Week 10 (Visit 4) | compliance(%) will be measured to day of usage/total period\*100 |
| The investigational device(application) usage compliance by body mass index [BMI] before discharge from hospital | Week 10 (Visit 4) | weight and height will be combined to report BMI in kg/m\^2, compliance(%) will be measured to day of usage/total period\*100 |
| The investigational device(application) usage compliance by status of postoperative anticancer therapy | Week 10 (Visit 4) | compliance(%) will be measured to day of usage/total period\*100 |
| Frequency of each symptom between visits after using the investigational device (application) | Week 2 (Visit 2), Week 6 (Visit 3), Week 10 (Visit 4) | Refer to Title |
| The investigational device(application) usage compliance by age | Week 10 (Visit 4) | compliance(%) will be measured to day of usage/total period\*100 |
| Correlation between change from Day 1 in body weight at Week 10 (Visit 4) and protein intake goal achievement rate | Week 10 (Visit 4) | Refer to Title |
| Change from baseline (Visit 1) in 'EORTC QLQ-C30' score | baseline (Visit 1), Week 10 (Visit 4) | Refer to Title |
| Change from baseline (Visit 1) in 'EORTC QLQ-STO22' score | baseline (Visit 1), Week 10 (Visit 4) | Refer to Title |
| Change from baseline (Visit 1) in 'KOQUSS Index' score | baseline (Visit 1), Week 10 (Visit 4) | Refer to Title |
| Correlation between change from Day 1 in body weight at Week 10 (Visit 4) and calory goal achievement rate | Week 10 (Visit 4) | Refer to Title |
| The investigational device(application) usage compliance by gender | Week 10 (Visit 4) | compliance(%) will be measured to day of usage/total period\*100 |
| The investigational device(application) usage compliance by surgery | Week 10 (Visit 4) | compliance(%) will be measured to day of usage/total period\*100 |
| The investigational device(application) usage compliance by stage of disease | Week 10 (Visit 4) | compliance(%) will be measured to day of usage/total period\*100 |
Other
| Measure | Time frame | Description |
|---|---|---|
| Frequency of Adverse Events | Week 2 (Visit 2), Week 6 (Visit 3), Week 10 (Visit 4) | Incident rate of Adverse Events will be reported |
| Frequency of each symptom by baseline characteristics (age, gender, surgery, stage of disease, BMI before discharge from hospital, status of postoperative anticancer therapy, underlying disease) | Week 10 (Visit 4) | Refer to Title |
Countries
South Korea
Outcome results
None listed