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

NCT07187154 | Recruiting

• 1 other identifier: NCC3765
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

1. 1.Research methods Constructed the "Manual for Graded Management of Postoperative Symptoms of Esophageal Cancer" and developed continuous care Procedures.
2. 2.Randomised controlled studies were conducted to verify the effects of the procedure.

Conditions

Esophageal Cancer

Outcome Measures

Primary Outcomes (1)

• 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.

  12 weeks after surgery

Secondary Outcomes (3)

• the proportion of patients with a score ≥4 for each individual symptom items

  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)

  12 weeks after surgery

• 30-day unplanned hospital readmission rate (including emergency department visits or unscheduled outpatient visits).

  30 days after surgery

Study Arms (2)

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.

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.

Interventions

Smart Symptom Management Program DEVICE

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.

Group 1：Smart Symptom Management Program

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The patient is aware and able to communicate in Mandarin;
• There are smartphones；
• Proficient in using WeChat mini programs.

You may not qualify if:

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

Sponsors & Collaborators

• Cancer Institute and Hospital, Chinese Academy of Medical Sciences: lead

Study Sites (1)

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Beijing, China

RECRUITING

MeSH Terms

Conditions

Esophageal Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases

Central Study Contacts

YUAN YU

CONTACT

13810600173; zlyyyuyuan@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 18, 2023
• First Posted: September 22, 2025
• Study Start: May 2, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): February 1, 2027
• Last Updated: June 16, 2026

Record last verified: 2026-05

Locations

CN (1)