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NCT Number: NCT07187154

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

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Beijing, China

Location status: Recruiting

Location contact

YUAN YU

CONTACT

[email protected]

8613810600173

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. 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.

Secondary outcomes

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

    Time frame: 12 weeks after surgery

  2. 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

  3. 30-day unplanned hospital readmission rate (including emergency department visits or unscheduled outpatient visits).

    Time frame: 30 days after surgery

Study contacts

Contact information is provided by the study sponsor or research team.

YUAN YU

CONTACT

[email protected]

13810600173

Sponsors and collaborators

Lead sponsor

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Other

Registry information

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
Sep 22, 2025
Registry last updated
Jun 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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