Esophageal CancerNCT07024849
Developing an Ecological and Tailored Nutritional Intervention to Improve Quality of Life in Esophageal Cancer Survivors
A study testing Ecological nutritional intervention in people with Esophageal Cancer, run by Samsung Medical Center at 1 site in South Korea.
Trial summary
This study aims to apply and assess the clinical feasibility of a health behavior theory-based ecological nutrition intervention program, providing nutrition care tailored to the unmet needs of esophageal cancer survivors after surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Esophageal Cancer
- What is being tested?
- Ecological nutritional intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSouth Korea
- Study dates
- 3 Apr 2025to 31 Dec 2025
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with clinical stage 1-3 primary esophageal cancer at diagnosis who have planned or received treatment, including esophageal resection and reconstruction, with curative intent, and their families*.
- You are at least 18 years of age
- Have a native-level understanding of Korean
- Who consented to this study
Who cannot join
- Concurrent multiple cancers at the time of diagnosis or a history of diagnosed and treated other organ cancers within the past year at the time of diagnosis
- Have had esophageal resection and reconstruction surgery for other reasons before being diagnosed with esophageal cancer
- Persons with limited cognitive and communication abilities
- The patient has had problems progressing to oral feeding after surgery, requiring a concurrent ileostomy, or the investigator determines that an interventional study is not appropriate.
- Individuals with reduced renal function for whom protein intake is not recommended (estimated GFR <60 mL/min/1.73 m2)
- People who are unable to walk due to joint problems, paralysis, etc.
- Those who do not use smartphones
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site, 1 recruiting
- Recruiting
Samsung Medical Center
Seoul, Seoul, 06351
Juhee Cho, PhD, +8234101448, alfadur2j@gmail.com
Genehee Lee, PhD, +8234101062, genehee@gmail.com
About this study
This study aims to apply and assess the clinical feasibility of a health behavior theory-based ecological nutrition intervention program, providing nutrition care tailored to the unmet needs of esophageal cancer survivors after surgery.
Esophageal cancer survivors will receive a 4-week nutrition intervention program tailored to their individual nutritional needs. The program includes providing nutritional guidelines, customized care food, encouraging walking through a wearable device, and weekly telephone counseling. The evaluation of the program will assess food intake, adherence to dietary guidelines, activity level, nutritional indicators (such as PNI and NRI), weight change, fatigue, symptoms, quality of life, and satisfaction with meals and services. Additionally, interviews will be conducted after the intervention to evaluate the patient's experience.
- Conditions
- Esophageal Cancer
- Being tested
- Ecological nutritional intervention
- Keywords
- nutritional intervention, nutrition, survivors, esophageal cancer, care foods, health behavior, ecological intervention
- Medical subject headings
- Esophageal Neoplasms, Health Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ecological nutritional interventionDietary supplement
Patients in the intervention arm will receive a 4-week nutrition management program(1 week for patients more than 4 months post-surgery), which includes providing nutritional guidelines, home delivery of personalized care foods, encouragement of physical activity using a wearable device, and weekly phone calls to check on nutritional goals and symptoms. Management services are also available through the mobile application.
| Study group | Role | What they receive |
|---|---|---|
| Nutrition Intervention group | Experimental | This is a single-arm study, with all participants in the intervention arm. Patients in the intervention arm will receive a 4-week nutrition management program. Receives: Dietary Supplement: Ecological nutritional intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Survey Questionnaire on Health Behavior Change through an Intervention Program
Adherence to nutritional guidelines including food intake
Measured: Baseline, end of intervention (post-enrollment 4 weeks)
Secondary outcomes (11)
Change in body weight (kg)
Change in body weight measured in kilograms from baseline to end of intervention.
Measured: Baseline, end of intervention (post-enrollment 4 weeks)
Change in body composition (fat mass and fat-free mass)
Change in body composition assessed by bioimpedance analysis or DXA scan from baseline to end of intervention.
Measured: Baseline, end of intervention (post-enrollment 4 weeks)
Change in Body Mass Index (BMI) (kg/m²)
Change in BMI calculated from weight and height from baseline to end of intervention.
Measured: Baseline, end of intervention (post-enrollment 4 weeks)
Change in Patient-Generated Subjective Global Assessment Short Form (PG-SGA-SF) score
Change in nutritional status assessed by the Patient-Generated Subjective Global Assessment Short Form (PG-SGA-SF) questionnaire (score range: 0-35, higher score indicates worse nutritional status) from baseline to end of intervention.
Measured: Baseline, end of intervention (post-enrollment 4 weeks)
Change in Gastrointestinal Symptom Rating Scale (GSRS) score
Change in gastrointestinal symptoms assessed by the Gastrointestinal Symptom Rating Scale (GSRS) questionnaire (score range: 1-7, higher score indicates more severe symptoms) from baseline to end of intervention.
Measured: Baseline, end of intervention (post-enrollment 4 weeks)
Change in dumping syndrome assessed by clinical questionnaire
Change in presence or severity of dumping syndrome assessed by clinical questionnaire or evaluation from baseline to end of intervention.
Measured: Baseline, end of intervention (post-enrollment 4 weeks)
Change in EQ-5D-5L (EuroQol-5 Dimensions-5 Levels) score
Change in quality of life assessed by the EQ-5D-5L questionnaire (score range: 0-1, higher score indicates better quality of life) from baseline to end of intervention.
Measured: Baseline, end of intervention (post-enrollment 4 weeks)
Change in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) score
Change in quality of life assessed by the EORTC QLQ-C30 (The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core30) questionnaire (score range varies by domain; higher score in function scales indicates better function, higher score in symptom scales indicates worse symptoms) from baseline to end of intervention.
Measured: Baseline, end of intervention (post-enrollment 4 weeks)
Change in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Oesophageal Cancer Module (EORTC QLQ-OES18) score
Change in quality of life specific to esophageal cancer assessed by the EORTC QLQ-OES18 (The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Oesophagus 18) questionnaire (score range varies by domain; higher score in function scales indicates better function, higher score in symptom scales indicates worse symptoms) from baseline to end of intervention.
Measured: Baseline, end of intervention (post-enrollment 4 weeks)
Change in patient satisfaction assessed by satisfaction survey
Change in patient satisfaction assessed by satisfaction survey (score range: specify, e.g., 1-5, higher score indicates higher satisfaction) from baseline to end of intervention.
Measured: End of intervention (post-enrollment 4 weeks)
Service-experience assessed by qualitative interview
Qualitative assessment of service experience through interview at end of intervention.
Measured: End of intervention (post-enrollment 4 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2025
- Study start3 Apr 2025
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esophageal CancerStudies of the same condition, open and under way.
- More trials run by Samsung Medical CenterThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Juhee Cho, Samsung Medical Center
- Investigators
- Juhee Cho, PhD, Principal investigator, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07024849
- Sponsor's protocol ID
- 2023-05-127
- Other IDs
- RS-2023-CC139778
- Status last verified
- Jun 2025
- First submitted
- 12 May 2025
- Last updated
- 17 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Developing an Ecological and Tailored Nutritional Intervention to Improve Quality of Life in Esophageal Cancer Survivors
- ClinicalTrials.gov ID
- NCT07024849
- Acronym / sponsor ID
- 2023-05-127
- Conditions
- Esophageal Cancer
- Keywords
- nutritional intervention, nutrition, survivors, esophageal cancer, care foods, health behavior, ecological intervention
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- 3 Apr 2025 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 17 Jun 2025 (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 study aims to apply and assess the clinical feasibility of a health behavior theory-based ecological nutrition intervention program, providing nutrition care tailored to the unmet needs of esophageal cancer survivors after surgery.
Esophageal cancer survivors will receive a 4-week nutrition intervention program tailored to their individual nutritional needs. The program includes providing nutritional guidelines, customized care food, encouraging walking through a wearable device, and weekly telephone counseling. The evaluation of the program will assess food intake, adherence to dietary guidelines, activity level, nutritional indicators (such as PNI and NRI), weight change, fatigue, symptoms, quality of life, and satisfaction with meals and services. Additionally, interviews will be conducted after the intervention to evaluate the patient's experience.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Nutrition Intervention group | Experimental | Dietary Supplement: Ecological nutritional interventionThis is a single-arm study, with all participants in the intervention arm. Patients in the intervention arm will receive a 4-week nutrition management program. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients with clinical stage 1-3 primary esophageal cancer at diagnosis who have planned or received treatment, including esophageal resection and reconstruction, with curative intent, and their families*.
- You are at least 18 years of age
- Have a native-level understanding of Korean
- Who consented to this study
Key exclusion criteria (7 listed)
- Concurrent multiple cancers at the time of diagnosis or a history of diagnosed and treated other organ cancers within the past year at the time of diagnosis
- Have had esophageal resection and reconstruction surgery for other reasons before being diagnosed with esophageal cancer
- Persons with limited cognitive and communication abilities
- The patient has had problems progressing to oral feeding after surgery, requiring a concurrent ileostomy, or the investigator determines that an interventional study is not appropriate.
- Individuals with reduced renal function for whom protein intake is not recommended (estimated GFR <60 mL/min/1.73 m2)
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 |
|---|---|---|
| Ecological nutritional interventionPatients in the intervention arm will receive a 4-week nutrition management program(1 week for patients more than 4 months post-surgery), which includes providing nutritional guidelines, home delivery of personalized care foods, encouragement of physical activity using a wearable device, and weekly phone calls to check on nutritional goals and symptoms. Management services are also available through the mobile application. | Dietary supplement | Nutrition Intervention group |
Primary outcome
Survey Questionnaire on Health Behavior Change through an Intervention Program
Time frame: Baseline, end of intervention (post-enrollment 4 weeks)
Adherence to nutritional guidelines including food intake
11 secondary outcomes
Change in body weight (kg)
Time frame: Baseline, end of intervention (post-enrollment 4 weeks)
Change in body composition (fat mass and fat-free mass)
Time frame: Baseline, end of intervention (post-enrollment 4 weeks)
Change in Body Mass Index (BMI) (kg/m²)
Time frame: Baseline, end of intervention (post-enrollment 4 weeks)
Change in Patient-Generated Subjective Global Assessment Short Form (PG-SGA-SF) score
Time frame: Baseline, end of intervention (post-enrollment 4 weeks)
Change in Gastrointestinal Symptom Rating Scale (GSRS) score
Time frame: Baseline, end of intervention (post-enrollment 4 weeks)
Change in dumping syndrome assessed by clinical questionnaire
Time frame: Baseline, end of intervention (post-enrollment 4 weeks)
Change in EQ-5D-5L (EuroQol-5 Dimensions-5 Levels) score
Time frame: Baseline, end of intervention (post-enrollment 4 weeks)
Change in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) score
Time frame: Baseline, end of intervention (post-enrollment 4 weeks)
Change in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Oesophageal Cancer Module (EORTC QLQ-OES18) score
Time frame: Baseline, end of intervention (post-enrollment 4 weeks)
Change in patient satisfaction assessed by satisfaction survey
Time frame: End of intervention (post-enrollment 4 weeks)
Service-experience assessed by qualitative interview
Time frame: End of intervention (post-enrollment 4 weeks)
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 17 Jun 2025.
- Individual participant dataSharing planned: No
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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.
Juhee Cho, PhD principal investigator
Samsung Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ecological nutritional intervention in people with Esophageal Cancer, run by Samsung Medical Center 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 4 inclusion and 7 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 17 Jun 2025. 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?
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 Juhee Cho, PhD (+8234101448, alfadur2j@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Survey Questionnaire on Health Behavior Change through an Intervention Program (time frame: Baseline, end of intervention (post-enrollment 4 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 17 Jun 2025.