Gastric CancerNCT06395935
Wecare Study in Gastric Cancer Survivors
A study testing Wecare (website) in people with Gastric Cancer, run by Gyeongsang National University Hospital at 1 site in South Korea.
Trial summary
The KOrean QUality of life in Stomach cancer patients Study group (KOQUSS) made a method (KOQUSS-40) for assessing appropriately the quality of life of gastric cancer patients who have undergone gastrectomy, and developed a digital platform (Wecare) based on KOQUSS-40. Read more about this study
- Who is it for?
- Ages 19 to 75 years
- Conditions the study is for
- Gastric Cancer
- What is being tested?
- Wecare (website)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Apr 2024to 30 Mar 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patient (19-75 years) who underwent radical gastrectomy
Who cannot join
- Patients who were unable to undergo regular follow-up, lacked communication, or were deemed unsuitable to participate in this study by the researcher
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Gyeongsang National University Hospital
Changwon, Gyeongsandnam-do, 51472
Sangho Jeong, MD, +820552143771, jshgnu@gmail.com
About this study
Official title: A Multi-center, Prospective, Randomized Study to Evaluate the Usefulness of Applying the Chronic Side Effect Management Platform (Wecare) in Gastric Cancer Survivors
The KOrean QUality of life in Stomach cancer patients Study group (KOQUSS) made a method (KOQUSS-40) for assessing appropriately the quality of life of gastric cancer patients who have undergone gastrectomy, and developed a digital platform (Wecare) based on KOQUSS-40. In this study, we propose a randomized controlled trial to compare quality of life after gastrectomy in patients with and without smartphone app support.
Read the detailed description
Smartphone apps have been gaining popularity in the delivery of lifestyle interventions in chronic disease management. In patients with cancer, randomized clinical trials have investigated the effect of smartphone-based interventions and reported improved quality of recovery and equal satisfaction with care compared with conventional in-person follow-up. However, there are no studies yet in which smartphone apps have evaluated the quality of life in patients after gastric cancer surgery.
Surgery is the mainstay of gastric cancer treatment. The proportion of patients with early gastric cancer and their survival rate of gastric cancer patients are increasing in East Asia thanks to the nationwide endoscopy screening program. As the number of long-term survivors after gastric cancer surgery increases, interest in the quality of life after surgery is also increasing. After gastrectomy, the remaining stomach volume is reduced or lost, and the vagus nerve is damaged during the surgery, which has various effects on the motor function and hormone secretion function of the stomach. Patients experience postgastrectomy syndrome, which includes lethargy, decreased appetite, early satiety, weight loss, abdominal distension, gastroesophageal reflux symptoms, diarrhea, anemia, and dumping syndrome. In addition to these physical symptoms, patients experience various symptoms and aftereffects after stomach cancer surgery, including psychological reactions such as fear, anxiety, and depression, and social problems such as avoidance of interpersonal relationships, social isolation, and difficulty returning to society.
- Conditions
- Gastric Cancer
- Being tested
- Wecare (website)
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Wecare (website)Other
support feedback of qutionaire \& supply educational contents
| Study group | Role | What they receive |
|---|---|---|
| conventional group | No intervention | In the control group, participants will be asked to complete written questionnaires in the outpatient clinic before surgery and at 1, 3, and 6 months after surgery. Based on the questionnaires, a clinician will provide a solution at an outpatient clinic. However, the Wecare® platform was not provided. . |
| Wecare group | Experimental | In the intervention group, participants will be asked to use the Wecare® platform (Figure 2). The Wecare® platform administers QoL questionnaires, including the KOQUSS-40 and EORTC QLQ-C30, following gastrectomy to treat gastric cancer. Based on participants' responses, The platform automatically generates expert recommendations from gastric cancer specialists based on participants' responses according to the timing of surgery after gastrectomy. Furthermore, the Wecare® platform offers educational materials on gastric cancer to address participants' questions about the disease. Participants will be free to use the platform but will be asked to visit the Wecare® platform at least once a month and answer questionnaires. Participants will visit an outpatient clinic before surgery and at 1, 3, and 6 months after surgery. Receives: Other: Wecare (website) |
What is being measured
The primary outcome is the main question the study is designed to answer.
the quality of life in gastric cancer survivor (KOQUSS-40)
KOQUSS-40 questionnaire has a 40-item questionnaire in 11 domains focusing on the symptoms evaluation after gastric cancer surgery.
Measured: at 1, 3, and 6 months after surgery in the outpatient clinic.
Secondary outcomes (3)
Weight
Weight change
Measured: at 1, 3, and 6 months after surgery in the outpatient clinic.
nutritional index
nutritional index change
Measured: at 1, 3, and 6 months after surgery in the outpatient clinic.
KOQUSS-40 questionnaire compliance
check the KOQUSS-40 questionnaire compliance
Measured: at 1, 3, and 6 months after surgery in the outpatient clinic.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2024
- Study start1 Apr 2024
- Primary completion30 Nov 2025 (estimated)
- Study completion30 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 88 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gyeongsang National University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Center, Korea
- Responsible party
- Sponsor
- Investigators
- Sang-Ho Jeong, MD, Principal investigator, Gyeongsang National University Changwon Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06395935
- Sponsor's protocol ID
- Wecare2024
- Status last verified
- Oct 2024
- First submitted
- 29 Apr 2024
- Last updated
- 15 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: if request, we can share the IPD without personal data.
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center, Prospective, Randomized Study to Evaluate the Usefulness of Applying the Chronic Side Effect Management Platform (Wecare) in Gastric Cancer Survivors
- ClinicalTrials.gov ID
- NCT06395935
- Acronym / sponsor ID
- Wecare2024
- Conditions
- Gastric Cancer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 88 participants (estimated)
- Lead sponsor
- Gyeongsang National University HospitalUniversity, hospital or other
- Collaborators
- National Cancer Center, Korea
- Study start
- 1 Apr 2024 (actual)
- Primary completion
- 30 Nov 2025 (estimated)
- Study completion
- 30 Mar 2026 (estimated)
- First posted
- 2 May 2024 (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.
The KOrean QUality of life in Stomach cancer patients Study group (KOQUSS) made a method (KOQUSS-40) for assessing appropriately the quality of life of gastric cancer patients who have undergone gastrectomy, and developed a digital platform (Wecare) based on KOQUSS-40. In this study, we propose a randomized controlled trial to compare quality of life after gastrectomy in patients with and without smartphone app support.
Detailed description
Smartphone apps have been gaining popularity in the delivery of lifestyle interventions in chronic disease management. In patients with cancer, randomized clinical trials have investigated the effect of smartphone-based interventions and reported improved quality of recovery and equal satisfaction with care compared with conventional in-person follow-up. However, there are no studies yet in which smartphone apps have evaluated the quality of life in patients after gastric cancer surgery.
Surgery is the mainstay of gastric cancer treatment. The proportion of patients with early gastric cancer and their survival rate of gastric cancer patients are increasing in East Asia thanks to the nationwide endoscopy screening program. As the number of long-term survivors after gastric cancer surgery increases, interest in the quality of life after surgery is also increasing. After gastrectomy, the remaining stomach volume is reduced or lost, and the vagus nerve is damaged during the surgery, which has various effects on the motor function and hormone secretion function of the stomach. Patients experience postgastrectomy syndrome, which includes lethargy, decreased appetite, early satiety, weight loss, abdominal distension, gastroesophageal reflux symptoms, diarrhea, anemia, and dumping syndrome. In addition to these physical symptoms, patients experience various symptoms and aftereffects after stomach cancer surgery, including psychological reactions such as fear, anxiety, and depression, and social problems such as avoidance of interpersonal relationships, social isolation, and difficulty returning to society.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| conventional group | No intervention | –In the control group, participants will be asked to complete written questionnaires in the outpatient clinic before surgery and at 1, 3, and 6 months after surgery. Based on the questionnaires, a clinician will provide a solution at an outpatient clinic. However, the Wecare® platform was not provided. . |
| Wecare group | Experimental | Other: Wecare (website)In the intervention group, participants will be asked to use the Wecare® platform (Figure 2). The Wecare® platform administers QoL questionnaires, including the KOQUSS-40 and EORTC QLQ-C30, following gastrectomy to treat gastric cancer. Based on participants' responses, The platform automatically generates expert recommendations from gastric cancer specialists based on participants' responses according to the timing of surgery after gastrectomy. Furthermore, the Wecare® platform offers educational materials on gastric cancer to address participants' questions about the disease. Participants will be free to use the platform but will be asked to visit the Wecare® platform at least once a month and answer questionnaires. Participants will visit an outpatient clinic before surgery and at 1, 3, and 6 months after surgery. |
Who may qualify
- Ages
- 19 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adult patient (19-75 years) who underwent radical gastrectomy
Key exclusion criteria (1 listed)
- Patients who were unable to undergo regular follow-up, lacked communication, or were deemed unsuitable to participate in this study by the researcher
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 |
|---|---|---|
| Wecare (website)support feedback of qutionaire \& supply educational contents | Other | Wecare group |
Primary outcome
the quality of life in gastric cancer survivor (KOQUSS-40)
Time frame: at 1, 3, and 6 months after surgery in the outpatient clinic.
KOQUSS-40 questionnaire has a 40-item questionnaire in 11 domains focusing on the symptoms evaluation after gastric cancer surgery.
3 secondary outcomes
Weight
Time frame: at 1, 3, and 6 months after surgery in the outpatient clinic.
nutritional index
Time frame: at 1, 3, and 6 months after surgery in the outpatient clinic.
KOQUSS-40 questionnaire compliance
Time frame: at 1, 3, and 6 months after surgery in the outpatient clinic.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2024.
- Individual participant dataSharing planned: Yes. if request, we can share the IPD without personal data.
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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. This study is not recruiting at the moment.
Sang-Ho Jeong, MD principal investigator
Gyeongsang National University Changwon Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Wecare (website) in people with Gastric Cancer, run by Gyeongsang National University Hospital at 1 site 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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 15 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sook-Ran Park (+82552142318, sr0218@naver.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the quality of life in gastric cancer survivor (KOQUSS-40) (time frame: at 1, 3, and 6 months after surgery in the outpatient clinic.). 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 15 Oct 2024.