Early Gastric CancerNCT07405931
Evaluation of the Effectiveness of Managing Chemotherapy Side Effects Using ePRO and a Standardized Telenursing Program for Cancer Patients
A study testing Standardized Telenursing and Smart Cancer Care Plus in people with Early Gastric Cancer and Advanced Gastric Cancer, run by Ulsan University Hospital at 5 sites in South Korea.
Trial summary
This is a multicenter randomized controlled clinical trial designed to evaluate the clinical efficacy and cost-effectiveness of a digital health platform that integrates a symptom reporting and management software with a standardized telenursing program, allowing cancer patients to actively monitor, report, and… Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Early Gastric Cancer, Advanced Gastric Cancer, Early Lung Cancer
- What is being tested?
- Standardized Telenursing and Smart Cancer Care Plus
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 414 participants
- Where
- 5 sitesSouth Korea
- Study dates
- 9 Jul 2025to Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged 19 years or older
- Diagnosed with early or advanced gastric, lung, breast, or colon cancer
- Starting first-cycle chemotherapy with a new anticancer agent
- Able to use a smartphone without difficulty
- Willing to provide informed consent to participate in the study
Who cannot join
- Individuals who have difficulty communicating due to cognitive impairment, visual impairment, hearing impairment, or other reasons
- Individuals who cannot read, write, or understand Korean
- Other individuals deemed inappropriate for participation by the investigators
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
South Korea5 sites, 5 recruiting
- Recruiting
Kosin University Gospel Hospital
Busan
Kim, +8210-6227-6721, kimeunji514@naver.com
- Recruiting
National Cancer Center, Korea
Goyang
Kim, +8210-9050-4257, bst7978@ncc.re.kr
- Not yet recruiting
Gachon University Gil Medical Center
Incheon
Choi, +8210-9271-7739, hihi7739@naver.com
- Recruiting
Gyeongsang National University
Jinju
Kim, +8210-3533-0595, mamagirl75@hanmail.net
- Recruiting
Ulsan University Hospital
Ulsan
Song, +82522507018, 9204564@uuh.ulsan.kr
About this study
This is a multicenter randomized controlled clinical trial designed to evaluate the clinical efficacy and cost-effectiveness of a digital health platform that integrates a symptom reporting and management software with a standardized telenursing program, allowing cancer patients to actively monitor, report, and self-manage chemotherapy-related adverse effects.
- Conditions
- Early Gastric Cancer, Advanced Gastric Cancer, Early Lung Cancer, Advanced Lung Cancer, Early Breast Cancer, Advanced Breast Cancer
- Being tested
- Standardized Telenursing, Smart Cancer Care Plus
- Medical subject headings
- Stomach Neoplasms, Lung Neoplasms, Breast Neoplasms, Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standardized TelenursingOther
Within Smart Cancer Care Plus, predefined criteria are applied to trigger standardized telenursing interventions. When patients report symptoms of Grade 3 or higher severity, or when a scheduled weekly symptom report is not submitted within 48 hours of the designated reporting date, a structured telephone counseling session is initiated. This process is intended to ensure timely clinical follow-up, support appropriate self-management, and prevent the progression of unmanaged adverse events.
Smart Cancer Care PlusOther
Also called Smart Caner Care Plus
Smart Cancer Care Plus is a digital platform for patient-reported symptom monitoring and management, developed for individuals receiving chemotherapy. The system enables structured reporting of chemotherapy-related adverse events and provides standardized information regarding the severity grading of symptoms, accompanied by evidence-based self-management strategies. This intervention is intended to promote systematic symptom monitoring and to facilitate timely clinical responses to adverse events.
| Study group | Role | What they receive |
|---|---|---|
| Standard Care Group | No intervention | Standard care group is the control group, receiving standard care only without using Smart Cancer Care Plus or standardized telenursing. |
| ePRO Group | Experimental | ePRO group is the experimental group, using Smart Cancer Care Plus without standardized telenursing. Receives: Other: Smart Cancer Care Plus |
| ePRO + Telenursing Group | Experimental | ePRO + Telenursing group is the experimental group, using Smart Cancer Care Plus in combination with standardized telenursing. Receives: Other: Standardized Telenursing; Other: Smart Cancer Care Plus |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of life Measured by EORTC QLQ-C30
Quality of life will be assessed using the Global Health Status/Quality of Life scale of the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30). The score for the Global Health Status/Quality of Life scale ranges from 0 to 100, with higher scores indicating better quality of life.
Measured: 12 weeks
Secondary outcomes (8)
Self-management, which will be assessed using the SECD-6-K
Self-management will be assessed using the Self-Efficacy for Chronic Disease Scale-6 Item, Korean Version (SECD-6-K). The SECD-6-K consists of 6 items, each rated on a 10-point Likert scale (1-10). The total score ranges from 6 to 60, with higher scores indicating better self-management.
Measured: 6 months
Self-rated overall health, which will be assessed using EQ-5D-VAS
Self-rated overall health will be assessed using the EuroQol Visual Analogue Scale (EQ-5D-VAS). Participants rate their overall health on a visual analogue scale ranging from 0 to 100, where 0 represents the worst imaginable health state and 100 represents the best imaginable health state. Higher scores indicate better self-rated health.
Measured: 6 months
Adherence to ePROSW
Adherence to ePROSW will be assessed by measuring the frequency of app usage over the entire 6-month study period. App adherence is defined as the total number of times participants accessed and used the ePROSW application during the study period.
Measured: 6 months
Chemotherapy Adherence
Chemotherapy adherence will be evaluated by the percentage of planned chemotherapy completed. Adherence will be calculated as the ratio of the administered dose to the planned dose, expressed as a percentage.
Measured: 6 months
Healthcare Utilization
Healthcare utilization will be assessed by the occurrence of unplanned hospital visits during the study period.
Measured: 6 months
Functional status, which will be assessed using EORTC-QLQ-C30
Functional status will be assessed using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30). The functional scales include physical functioning, role functioning, emotional functioning, cognitive functioning, and social functioning. Scores for each scale are linearly transformed to a 0-100 scale, with higher scores indicating better functioning.
Measured: 6 months
Symptom severity, which will be assessed using EORTC-QLQ-C30
Symptom severity will be assessed using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30). The symptom scales include fatigue, nausea and vomiting, pain, dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties. Scores for each symptom scale are linearly transformed to a 0-100 scale, with higher scores indicating greater symptom severity (worse outcome).
Measured: 6 months
Satisfaction, which will be assessed using system usability scale
User satisfaction with the system will be assessed using the System Usability Scale (SUS), a validated 10-item questionnaire. Each item is rated on a 5-point Likert scale (1 = strongly disagree to 5 = strongly agree). The total SUS score is calculated by multiplying the sum of item scores by 2.5, resulting in a range of 0 to 100, where higher scores indicate greater satisfaction (better usability).
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2026
- Study start9 Jul 2025
- Primary completionMar 2026 (estimated)
- Study completionSep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Early Gastric CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 414 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ulsan University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Center, Korea, Kosin University Gospel Hospital, Gyeongsang National University Hospital, Gachon University Gil Medical Center
- Responsible party
- Principal investigator, Koh Su-Jin, Ulsan University Hospital
- Investigators
- Sujin Koh, Doctor of Philoshophy, Principal investigator, Ulsan University HospitalKeun Soek Lee, Doctor of Philoshophy, Principal investigator, National Cancer Center, KoreaSung Hoon Sim, Doctor of Philoshophy, Principal investigator, National Cancer Center, KoreaJi Hyung Hong, Doctor of Philoshophy, Principal investigator, National Cancer Center, KoreaSun Jin Sym, Doctor of Philoshophy, Principal investigator, Gachon University Gil Medical CenterJung Hun Kang, Doctor of Philoshophy, Principal investigator, Gyeongsang National University HospitalSeong Hoon Shin, Doctor of Philoshophy, Principal investigator, Kosin University Gospel Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07405931
- Sponsor's protocol ID
- 2025-05-022
- Status last verified
- Aug 2025
- First submitted
- 22 Jan 2026
- Last updated
- 12 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effectiveness of Managing Chemotherapy Side Effects Using ePRO and a Standardized Telenursing Program for Cancer Patients
- ClinicalTrials.gov ID
- NCT07405931
- Acronym / sponsor ID
- 2025-05-022
- Conditions
- Early Gastric Cancer, Advanced Gastric Cancer, Early Lung Cancer, Advanced Lung Cancer, Early Breast Cancer, Advanced Breast Cancer
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 414 participants (estimated)
- Lead sponsor
- Ulsan University HospitalUniversity, hospital or other
- Collaborators
- National Cancer Center, Korea, Kosin University Gospel Hospital, Gyeongsang National University Hospital, Gachon University Gil Medical Center
- Study start
- 9 Jul 2025 (actual)
- Primary completion
- Mar 2026 (estimated)
- Study completion
- Sep 2026 (estimated)
- First posted
- 12 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a multicenter randomized controlled clinical trial designed to evaluate the clinical efficacy and cost-effectiveness of a digital health platform that integrates a symptom reporting and management software with a standardized telenursing program, allowing cancer patients to actively monitor, report, and self-manage chemotherapy-related adverse effects.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Standard Care Group | No intervention | –Standard care group is the control group, receiving standard care only without using Smart Cancer Care Plus or standardized telenursing. |
| ePRO Group | Experimental | Other: Smart Cancer Care PlusePRO group is the experimental group, using Smart Cancer Care Plus without standardized telenursing. |
| ePRO + Telenursing Group | Experimental | Other: Standardized Telenursing, Other: Smart Cancer Care PlusePRO + Telenursing group is the experimental group, using Smart Cancer Care Plus in combination with standardized telenursing. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adults aged 19 years or older
- Diagnosed with early or advanced gastric, lung, breast, or colon cancer
- Starting first-cycle chemotherapy with a new anticancer agent
- Able to use a smartphone without difficulty
- Willing to provide informed consent to participate in the study
Key exclusion criteria (3 listed)
- Individuals who have difficulty communicating due to cognitive impairment, visual impairment, hearing impairment, or other reasons
- Individuals who cannot read, write, or understand Korean
- Other individuals deemed inappropriate for participation by the investigators
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standardized TelenursingWithin Smart Cancer Care Plus, predefined criteria are applied to trigger standardized telenursing interventions. When patients report symptoms of Grade 3 or higher severity, or when a scheduled weekly symptom report is not submitted within 48 hours of the designated reporting date, a structured telephone counseling session is initiated. This process is intended to ensure timely clinical follow-up, support appropriate self-management, and prevent the progression of unmanaged adverse events. | Other | ePRO + Telenursing Group |
| Smart Cancer Care PlusAlso: Smart Caner Care PlusSmart Cancer Care Plus is a digital platform for patient-reported symptom monitoring and management, developed for individuals receiving chemotherapy. The system enables structured reporting of chemotherapy-related adverse events and provides standardized information regarding the severity grading of symptoms, accompanied by evidence-based self-management strategies. This intervention is intended to promote systematic symptom monitoring and to facilitate timely clinical responses to adverse events. | Other | ePRO + Telenursing Group, ePRO Group |
Primary outcome
Quality of life Measured by EORTC QLQ-C30
Time frame: 12 weeks
Quality of life will be assessed using the Global Health Status/Quality of Life scale of the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30). The score for the Global Health Status/Quality of Life scale ranges from 0 to 100, with higher scores indicating better quality of life.
8 secondary outcomes
Self-management, which will be assessed using the SECD-6-K
Time frame: 6 months
Self-rated overall health, which will be assessed using EQ-5D-VAS
Time frame: 6 months
Adherence to ePROSW
Time frame: 6 months
Chemotherapy Adherence
Time frame: 6 months
Healthcare Utilization
Time frame: 6 months
Functional status, which will be assessed using EORTC-QLQ-C30
Time frame: 6 months
Symptom severity, which will be assessed using EORTC-QLQ-C30
Time frame: 6 months
Satisfaction, which will be assessed using system usability scale
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2026.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sujin Koh, Doctor of Philoshophy principal investigator
Ulsan University Hospital
Keun Soek Lee, Doctor of Philoshophy principal investigator
National Cancer Center, Korea
Sung Hoon Sim, Doctor of Philoshophy principal investigator
National Cancer Center, Korea
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standardized Telenursing and Smart Cancer Care Plus in people with Early Gastric Cancer and Advanced Gastric Cancer, run by Ulsan University Hospital at 5 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Minseon Song, bachelor's degree (+82522507018, 9204564@uuh.ulsan.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of life Measured by EORTC QLQ-C30 (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2026.