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

NCT07187154 | Not Yet Recruiting

• 1 other identifier: NCC3765
• Study Type: interventional
• Target: 252
• 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 (4)

• Rate of Major Postoperative Complications

  The proportion of patients experiencing one or more postoperative complications with a Clavien-Dindo classification of Grade II or higher. Complications will be identified and graded by reviewing patient electronic medical records and discharge summaries. The outcome will be reported as a binary variable (yes/no), and the rate (percentage) will be calculated for each group.

  From the date of surgery until postoperative day 42 (6 weeks).

• 30-Day All-Cause Readmission Rate

  The proportion of patients readmitted to the hospital for any cause within 30 days of discharge. Data will be confirmed via hospital information system (HIS) records. The outcome will be reported as a percentage.

  From the date of hospital discharge until 30 days post-discharge.

• Mean Score of Symptom Severity Items on the MD Anderson Symptom Inventory (MDASI) Module for Esophageal Cancer

  Symptom severity will be assessed using the symptom severity subscale of the validated MD Anderson Symptom Inventory (MDASI) module for esophageal cancer. This subscale includes 13 core cancer-related symptoms. Patients will rate the severity of each symptom over the last 24 hours on a numeric scale from 0 ("not present") to 10 ("as bad as you can imagine"). The outcome value for each participant at each time point will be the mean score of these 13 symptom severity items. A higher mean score indicates a greater symptom burden.

  Assessed at baseline (preoperatively), and then at 1 month, 3 months, and 6 months postoperatively

• Mean Score of Symptom Interference Items on the MD Anderson Symptom Inventory (MDASI) Module for Esophageal Cancer

  The impact of symptoms on daily life will be assessed using the symptom interference subscale of the validated MD Anderson Symptom Inventory (MDASI) module for esophageal cancer. This subscale evaluates how symptoms have interfered with 6 different aspects of daily life (e.g., general activity, mood, work) over the last 24 hours. Ratings are on a numeric scale from 0 ("did not interfere") to 10 ("completely interfered"). The outcome value for each participant at each time point will be the mean score of these 6 symptom interference items. A higher mean score indicates a greater negative impact on daily life.

  Assessed at baseline (preoperatively), and then at 1 month, 3 months, and 6 months postoperatively

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

Location

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: April 1, 2026
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): December 28, 2026
• Last Updated: April 1, 2026

Record last verified: 2025-09

Locations

CN (1)