NuGa (Nutrition for Gastric Cancer Patients)

Sponsor

Seoul National University Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT04800991

Collaborator

(none)

Enrollment

Location

Arm

6.7

Actual Duration (Months)

5.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Gastric Cancer	Device: Rhexium Onco Nutrition	N/A

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

Actual Enrollment :

40 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

HDT-202(application)HDT-202(application)

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

Official Title:

A Pilot Study to Evaluate the Feasibility and Efficacy of Digital Health Technology for Postoperative Care With Gastrectomy-Treated Patients in Gastric Cancer

Actual Study Start Date :

Mar 17, 2021

Actual Primary Completion Date :

Oct 8, 2021

Actual Study Completion Date :

Oct 8, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Rhexium Onco Nutrition(HDT-202) "subject mobile application" and "Investigator web portal" with no invasive action on the human body	Device: Rhexium 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 Other Names: HDT-202

Arm

Intervention/Treatment

Experimental: Rhexium Onco Nutrition(HDT-202)

"subject mobile application" and "Investigator web portal" with no invasive action on the human body

Device: Rhexium 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

Other Names:

HDT-202

Outcome Measures

Primary Outcome Measures

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 (application)' questionnaire for subjects [Week 6 (Visit 3),]
higher scores mean a better outcome
Score of each domain of the 'feasibility assessment of the investigational device (application)' questionnaire for subjects [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 [Week 6 (Visit 3)]
higher scores mean a better outcome

Secondary Outcome Measures

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
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
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
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
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
The investigational device(application) usage compliance by underlying disease [Week 10 (Visit 4)]
compliance(%) will be measured to day of usage/total period*100

Other Outcome Measures

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
Frequency of Adverse Events [Week 2 (Visit 2), Week 6 (Visit 3), Week 10 (Visit 4)]
Incident rate of Adverse Events will be reported

Eligibility Criteria

Criteria

Ages Eligible for Study:

19 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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