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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Rhexium Onco Nutrition(HDT-202) | Experimental | "subject mobile application" and "Investigator web portal" with no invasive action on the human body |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rhexium Onco Nutrition | Device | The research devices in this study are classified into "subject mobile application" and "investigator web portal" with no invasive action on the human body |
| Measure | Description | Time Frame |
|---|---|---|
| Score of each domain of the 'feasibility assessment of the investigational device (application)' questionnaire for subjects | higher scores mean a better outcome | Week 2 (Visit 2) |
| Score of each domain of the 'feasibility assessment of the investigational device (application)' questionnaire for subjects | higher scores mean a better outcome | Week 6 (Visit 3), |
| Score of each domain of the 'feasibility assessment of the investigational device (application)' questionnaire for subjects | higher scores mean a better outcome | Week 10 (Visit 4) |
| Score of each domain of the 'feasibility assessment of the investigational device (website)' questionnaire for investigators | higher scores mean a better outcome | Week 6 (Visit 3) |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline (Visit 1) in 'EORTC QLQ-C30' score | Refer to Title | baseline (Visit 1), Week 10 (Visit 4) |
| Change from baseline (Visit 1) in 'EORTC QLQ-STO22' score | Refer to Title |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | Refer to Title | Week 10 (Visit 4) |
| Frequency of Adverse Events |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Han-Kwang Yang, PhD | Seoul National University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Surgery, Seoul National University Hospital | Seoul | 110-744 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39375057 | Derived | Park JH, Lee HJ, Kim J, Cho YS, Lee S, Park S, Choe H, Song E, Kim Y, Kong SH, Park DJ, Nam BH, Yang HK. Development and Feasibility Assessment of Mobile Application-Based Digital Therapeutics for Postoperative Supportive Care in Gastric Cancer Patients Following Gastrectomy. J Gastric Cancer. 2024 Oct;24(4):420-435. doi: 10.5230/jgc.2024.24.e37. |
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| ID | Term |
|---|---|
| D013274 | Stomach Neoplasms |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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HDT-202(application)
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|
| baseline (Visit 1), Week 10 (Visit 4) |
| Change from baseline (Visit 1) in 'KOQUSS Index' score | Refer to Title | baseline (Visit 1), Week 10 (Visit 4) |
| Correlation between change from Day 1 in body weight at Week 10 (Visit 4) and calory goal achievement rate | Refer to Title | Week 10 (Visit 4) |
| Correlation between change from Day 1 in body weight at Week 10 (Visit 4) and protein intake goal achievement rate | Refer to Title | Week 10 (Visit 4) |
| Frequency of each symptom between visits after using the investigational device (application) | Refer to Title | Week 2 (Visit 2), Week 6 (Visit 3), Week 10 (Visit 4) |
| The investigational device(application) usage compliance by age | compliance(%) will be measured to day of usage/total period*100 | Week 10 (Visit 4) |
| The investigational device(application) usage compliance by gender | compliance(%) will be measured to day of usage/total period*100 | Week 10 (Visit 4) |
| The investigational device(application) usage compliance by surgery | compliance(%) will be measured to day of usage/total period*100 | Week 10 (Visit 4) |
| The investigational device(application) usage compliance by stage of disease | compliance(%) will be measured to day of usage/total period*100 | Week 10 (Visit 4) |
| The investigational device(application) usage compliance by body mass index [BMI] before discharge from hospital | weight and height will be combined to report BMI in kg/m^2, compliance(%) will be measured to day of usage/total period*100 | Week 10 (Visit 4) |
| The investigational device(application) usage compliance by status of postoperative anticancer therapy | compliance(%) will be measured to day of usage/total period*100 | Week 10 (Visit 4) |
| The investigational device(application) usage compliance by underlying disease | compliance(%) will be measured to day of usage/total period*100 | Week 10 (Visit 4) |
Incident rate of Adverse Events will be reported
| Week 2 (Visit 2), Week 6 (Visit 3), Week 10 (Visit 4) |
| D004066 |
| Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |