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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorCancer Institute and Hospital, Chinese Academy of Medical Sciences

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

Have cognitive impairment or psychiatric illness;

Refusal to participate

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

300 Participants
are divided into 2 treatment groups
Group A: Group 1:Smart Symptom Management ProgramExperimental treatment 1 intervention
Group B: Group 2:Routine CareNo intervention 0 interventions

Trial outcomes

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.

Time frame
12 weeks after surgery

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.