Esophageal CancerNCT07187154
The Application of Symptoms Management Program Based on the Patient Reported Outcome After Esophagectomy
A study testing Smart Symptom Management Program in people with Esophageal Cancer, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences at 1 site in China.
Trial summary
1. Research methods Constructed the "Manual for Graded Management of Postoperative Symptoms of Esophageal Cancer" and developed continuous care Procedures. 2. Randomised controlled studies were conducted to verify the effects of the procedure. 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?
- Smart Symptom Management Program
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- 2 May 2026to 1 Feb 2027
- 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
- The patient is aware and able to communicate in Mandarin;
- There are smartphones；
- Proficient in using WeChat mini programs.
- Patients who were scheduled for esophageal cancer resection in participating centers were eligible for inclusion.
Who cannot join
- Have cognitive impairment or psychiatric illness;
- Refusal to participate
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Beijing
YUAN YU, 8613810600173, zlyyyuyuan@163.com
About this study
- Research methods Constructed the "Manual for Graded Management of Postoperative Symptoms of Esophageal Cancer" and developed continuous care Procedures.
- Randomised controlled studies were conducted to verify the effects of the procedure.
- Conditions
- Esophageal Cancer
- Being tested
- Smart Symptom Management Program
- Medical subject headings
- Esophageal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Smart Symptom Management ProgramDevice
During the first six months after surgery, patients in the experimental group will use a WeChat mini-program to proactively self-report their symptoms regularly using the Chinese version of the MD Anderson Symptom Inventory for Esophageal Cancer (MDASI-EC). Based on the reported scores and the pre-defined algorithms in the "Post-Esophagectomy Symptom Grading Management Manual", the system will automatically provide personalized self-management guidance for low-grade symptoms. For more severe symptoms, the system will generate alerts to prompt dedicated study nurses to initiate proactive telephone follow-up and provide tailored health coaching.
| Study group | Role | What they receive |
|---|---|---|
| Group 1：Smart Symptom Management Program | Experimental | During the first six months after surgery, patients in the experimental group will use a WeChat mini-program to proactively self-report their symptoms regularly using the Chinese version of the MD Anderson Symptom Inventory for Esophageal Cancer (MDASI-EC). Based on the reported scores and the pre-defined algorithms in the "Post-Esophagectomy Symptom Grading Management Manual", the system will automatically provide personalized self-management guidance for low-grade symptoms. For more severe symptoms, the system will generate alerts to prompt dedicated study nurses to initiate proactive telephone follow-up and provide tailored health coaching. Receives: Device: Smart Symptom Management Program |
| Group 2：Routine Care | No intervention | Patients in the control group will receive standard post-discharge care as per hospital protocol, which includes routine discharge education and instructions to contact the hospital if problems arise. They will not use the WeChat mini-program and will not receive proactive symptom monitoring or coaching calls. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of the proportion of patients with any of three esophageal cancer-specific symptoms (reflux, dysphagia, eating difficulty)
Primary outcome was the proportion of patients with any of three esophageal cancer-specific symptoms (reflux, dysphagia, eating difficulty) rated ≥4 on the MDASI-EC at 12 weeks after surgery. This composite endpoint was selected based on our prior symptom trajectory studies, as these three symptoms are the most common and most distressing after esophagectomy.
Measured: 12 weeks after surgery
Secondary outcomes (3)
the proportion of patients with a score ≥4 for each individual symptom items
Measured: 12 weeks after surgery
composite functional interference scores: WAW (the average of walking, general activity, work) and REM (the average of relations with others, mood, enjoyment of life)
Measured: 12 weeks after surgery
30-day unplanned hospital readmission rate (including emergency department visits or unscheduled outpatient visits).
Measured: 30 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2025
- Study start2 May 2026
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Feb 2027 (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 Cancer Institute and Hospital, Chinese Academy of Medical SciencesThe 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07187154
- Sponsor's protocol ID
- NCC3765
- Status last verified
- May 2026
- First submitted
- 18 Mar 2023
- Last updated
- 16 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Application of Symptoms Management Program Based on the Patient Reported Outcome After Esophagectomy
- ClinicalTrials.gov ID
- NCT07187154
- Acronym / sponsor ID
- NCC3765
- Conditions
- Esophageal Cancer
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Cancer Institute and Hospital, Chinese Academy of Medical SciencesUniversity, hospital or other
- Study start
- 2 May 2026 (actual)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 Feb 2027 (estimated)
- First posted
- 22 Sep 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.
- Research methods Constructed the "Manual for Graded Management of Postoperative Symptoms of Esophageal Cancer" and developed continuous care Procedures.
- Randomised controlled studies were conducted to verify the effects of the procedure.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1：Smart Symptom Management Program | Experimental | Device: Smart Symptom Management ProgramDuring the first six months after surgery, patients in the experimental group will use a WeChat mini-program to proactively self-report their symptoms regularly using the Chinese version of the MD Anderson Symptom Inventory for Esophageal Cancer (MDASI-EC). Based on the reported scores and the pre-defined algorithms in the "Post-Esophagectomy Symptom Grading Management Manual", the system will automatically provide personalized self-management guidance for low-grade symptoms. For more severe symptoms, the system will generate alerts to prompt dedicated study nurses to initiate proactive telephone follow-up and provide tailored health coaching. |
| Group 2：Routine Care | No intervention | –Patients in the control group will receive standard post-discharge care as per hospital protocol, which includes routine discharge education and instructions to contact the hospital if problems arise. They will not use the WeChat mini-program and will not receive proactive symptom monitoring or coaching calls. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- The patient is aware and able to communicate in Mandarin;
- There are smartphones；
- Proficient in using WeChat mini programs.
- Patients who were scheduled for esophageal cancer resection in participating centers were eligible for inclusion.
Key exclusion criteria (2 listed)
- Have cognitive impairment or psychiatric illness;
- Refusal to participate
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 |
|---|---|---|
| Smart Symptom Management ProgramDuring the first six months after surgery, patients in the experimental group will use a WeChat mini-program to proactively self-report their symptoms regularly using the Chinese version of the MD Anderson Symptom Inventory for Esophageal Cancer (MDASI-EC). Based on the reported scores and the pre-defined algorithms in the "Post-Esophagectomy Symptom Grading Management Manual", the system will automatically provide personalized self-management guidance for low-grade symptoms. For more severe symptoms, the system will generate alerts to prompt dedicated study nurses to initiate proactive telephone follow-up and provide tailored health coaching. | Device | Group 1：Smart Symptom Management Program |
Primary outcome
Rate of the proportion of patients with any of three esophageal cancer-specific symptoms (reflux, dysphagia, eating difficulty)
Time frame: 12 weeks after surgery
Primary outcome was the proportion of patients with any of three esophageal cancer-specific symptoms (reflux, dysphagia, eating difficulty) rated ≥4 on the MDASI-EC at 12 weeks after surgery. This composite endpoint was selected based on our prior symptom trajectory studies, as these three symptoms are the most common and most distressing after esophagectomy.
3 secondary outcomes
the proportion of patients with a score ≥4 for each individual symptom items
Time frame: 12 weeks after surgery
composite functional interference scores: WAW (the average of walking, general activity, work) and REM (the average of relations with others, mood, enjoyment of life)
Time frame: 12 weeks after surgery
30-day unplanned hospital readmission rate (including emergency department visits or unscheduled outpatient visits).
Time frame: 30 days after surgery
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 16 Jun 2026.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Smart Symptom Management Program in people with Esophageal Cancer, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences at 1 site in China.
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 2 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 16 Jun 2026. 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 China. 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 YUAN YU (13810600173, zlyyyuyuan@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of the proportion of patients with any of three esophageal cancer-specific symptoms (reflux, dysphagia, eating difficulty) (time frame: 12 weeks after surgery). 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 16 Jun 2026.