Clinical trial NCT04800991: NuGa (Nutrition for Gastric Cancer Patients)
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gastric Cancer
Keywords: Gastrectomy
postoperative care
nutrition
Digital health technology
Application
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2021-03-16
Enrollment: 40
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: HDT-202(application)
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Score of each domain of the 'feasibility assessment of the investigational device (application)' questionnaire for subjects
timeFrame: Week 2 (Visit 2)
measure: Score of each domain of the 'feasibility assessment of the investigational device (application)' questionnaire for subjects
timeFrame: Week 6 (Visit 3),
measure: Score of each domain of the 'feasibility assessment of the investigational device (application)' questionnaire for subjects
timeFrame: Week 10 (Visit 4)
measure: Score of each domain of the 'feasibility assessment of the investigational device (website)' questionnaire for investigators
timeFrame: Week 6 (Visit 3)
Secondary outcomes:
measure: Change from baseline (Visit 1) in 'EORTC QLQ-C30' score
timeFrame: baseline (Visit 1), Week 10 (Visit 4)
measure: Change from baseline (Visit 1) in 'EORTC QLQ-STO22' score
timeFrame: baseline (Visit 1), Week 10 (Visit 4)
measure: Change from baseline (Visit 1) in 'KOQUSS Index' score
timeFrame: baseline (Visit 1), Week 10 (Visit 4)
measure: Correlation between change from Day 1 in body weight at Week 10 (Visit 4) and calory goal achievement rate
timeFrame: Week 10 (Visit 4)
measure: Correlation between change from Day 1 in body weight at Week 10 (Visit 4) and protein intake goal achievement rate
timeFrame: Week 10 (Visit 4)
measure: Frequency of each symptom between visits after using the investigational device (application)
timeFrame: Week 2 (Visit 2), Week 6 (Visit 3), Week 10 (Visit 4)
measure: The investigational device(application) usage compliance by age
timeFrame: Week 10 (Visit 4)
measure: The investigational device(application) usage compliance by gender
timeFrame: Week 10 (Visit 4)
measure: The investigational device(application) usage compliance by surgery
timeFrame: Week 10 (Visit 4)
measure: The investigational device(application) usage compliance by stage of disease
timeFrame: Week 10 (Visit 4)
measure: The investigational device(application) usage compliance by body mass index [BMI] before discharge from hospital
timeFrame: Week 10 (Visit 4)
measure: The investigational device(application) usage compliance by status of postoperative anticancer therapy
timeFrame: Week 10 (Visit 4)
measure: The investigational device(application) usage compliance by underlying disease
timeFrame: Week 10 (Visit 4)
Other outcomes:
measure: 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)
timeFrame: Week 10 (Visit 4)
measure: Frequency of Adverse Events
timeFrame: Week 2 (Visit 2), Week 6 (Visit 3), Week 10 (Visit 4)
Locations:
city: Seoul
country: Korea, Republic of
facility: Department of Surgery, Seoul National University Hospital
Study officials:
affiliation: Seoul National University Hospital
name: Han-Kwang Yang, PhD
role: PRINCIPAL_INVESTIGATOR
References: