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

Not Applicable

Not yet recruiting

• Conditions: Esophageal Cancer

• Registration Number: NCT07187154
• Lead Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-03-18
• Status Verified: 2025-09
• Study First Submitted QC: 2025-09-16
• Last Update Submitted: 2025-09-16
• Study First Posted: 2025-09-22
• Last Update Posted: 2025-09-22
• Study Start: 2025-10-01
• Primary Completion: 2026-02-01
• Study Completion: 2026-02-28

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 252

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Rate of Major Postoperative Complications	From the date of surgery until postoperative day 42 (6 weeks).	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.
30-Day All-Cause Readmission Rate	From the date of hospital discharge until 30 days post-discharge.	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.
Mean Score of Symptom Severity Items on the MD Anderson Symptom Inventory (MDASI) Module for Esophageal Cancer	Assessed at baseline (preoperatively), and then at 1 month, 3 months, and 6 months postoperatively	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.
Mean Score of Symptom Interference Items on the MD Anderson Symptom Inventory (MDASI) Module for Esophageal Cancer	Assessed at baseline (preoperatively), and then at 1 month, 3 months, and 6 months postoperatively	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.

Trial Locations

Locations (1)

Cancer Institute and Hospital, Chinese Academy of Medical Sciences; 🇨🇳 Beijing, China