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The Application of Symptoms Management Program Based on the Patient Reported Outcome After Esophagectomy

The Application of Symptoms Management Program Based on the Patient Reported Outcome After Esophagectomy

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07187154
Enrollment
300
Registered
2025-09-22
Start date
2026-05-02
Completion date
2027-02-01
Last updated
2026-06-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Esophageal Cancer

Brief 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.

Interventions

DEVICESmart Symptom Management Program

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.

Sponsors

Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* 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.

Exclusion criteria

* Have cognitive impairment or psychiatric illness; * Refusal to participate

Design outcomes

Primary

MeasureTime frameDescription
Rate of the proportion of patients with any of three esophageal cancer-specific symptoms (reflux, dysphagia, eating difficulty)12 weeks after surgeryPrimary 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.

Secondary

MeasureTime frame
the proportion of patients with a score ≥4 for each individual symptom items12 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)12 weeks after surgery
30-day unplanned hospital readmission rate (including emergency department visits or unscheduled outpatient visits).30 days after surgery

Countries

China

Contacts

CONTACTYUAN YU
zlyyyuyuan@163.com13810600173

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 17, 2026