NCT04800991CompletedNot Applicable
A Pilot Study to Evaluate the Feasibility and Efficacy of Digital Health Technology for Postoperative Care With Gastrectomy-Treated Patients in Gastric Cancer
Seoul National University Hospital2 sites in 1 country40 target enrollmentStarted: March 17, 2021Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 40
- Locations
- 2
- Primary Endpoint
- Score of each domain of the 'feasibility assessment of the investigational device (application)' questionnaire for subjects
Study Overview
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
- A total of 4 visits will be performed.
- 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.
- 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.
- During the treatment period, telephone monitoring is conducted depending on the compliance of subjects.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 19 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patient who voluntarily signs the informed consent form for this study
- •Age of ≥19 years old
- •Patient who has undergone therapeutic gastrectomy after a diagnosis of gastric cancer
- •Able to eat food orally after gastrectomy
- •Patient who possesses an Android OS based mobile device and is capable of using the investigational device.
Exclusion Criteria
- •Other cancer or metastasis documented within 5 years prior to screening
- •Ongoing or planned enteral tube feeding or total parenteral nutrition
- •Other clinically significant medical or psychiatric findings based on which the individual is considered by the investigator to be ineligible
- •Individual who possesses a mobile device on which the application is unable to be installed and/or run normally for technical reasons
- •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
Outcomes
Primary Outcomes
Score of each domain of the 'feasibility assessment of the investigational device (application)' questionnaire for subjects
Time Frame: Week 10 (Visit 4)
higher scores mean a better outcome
Score of each domain of the 'feasibility assessment of the investigational device (website)' questionnaire for investigators
Time Frame: Week 6 (Visit 3)
higher scores mean a better outcome
Secondary Outcomes
- Change from baseline (Visit 1) in 'EORTC QLQ-C30' score(baseline (Visit 1), Week 10 (Visit 4))
- Change from baseline (Visit 1) in 'EORTC QLQ-STO22' score(baseline (Visit 1), Week 10 (Visit 4))
- The investigational device(application) usage compliance by age(Week 10 (Visit 4))
- The investigational device(application) usage compliance by body mass index [BMI] before discharge from hospital(Week 10 (Visit 4))
- Change from baseline (Visit 1) in 'KOQUSS Index' score(baseline (Visit 1), Week 10 (Visit 4))
- Frequency of each symptom between visits after using the investigational device (application)(Week 2 (Visit 2), Week 6 (Visit 3), Week 10 (Visit 4))
- The investigational device(application) usage compliance by stage of disease(Week 10 (Visit 4))
- The investigational device(application) usage compliance by status of postoperative anticancer therapy(Week 10 (Visit 4))
- The investigational device(application) usage compliance by underlying disease(Week 10 (Visit 4))
- The investigational device(application) usage compliance by gender(Week 10 (Visit 4))
- The investigational device(application) usage compliance by surgery(Week 10 (Visit 4))
- Correlation between change from Day 1 in body weight at Week 10 (Visit 4) and calory goal achievement rate(Week 10 (Visit 4))
- Correlation between change from Day 1 in body weight at Week 10 (Visit 4) and protein intake goal achievement rate(Week 10 (Visit 4))
Investigators
Han-Kwang Yang
Professor
Seoul National University Hospital
Study Sites (2)
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