Recruiting NCT07187154
The Application of Symptoms Management Program Based on the Patient Reported Outcome After Esophagectomy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Smart Symptom Management Program.
- Who it may be relevant to
- Registry conditions: Esophageal Cancer. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Device Smart Symptom Management Program
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 sym
Primary outcome measures
- Rate of the proportion of patients with any of three esophageal cancer-specific symptoms (reflux, dysphagia, eating difficulty) [Time frame: 12 weeks after surgery]
Secondary outcome measures (3)
- the proportion of patients with a score ≥4 for each individual symptom items [Time frame: 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) [Time frame: 12 weeks after surgery]
- 30-day unplanned hospital readmission rate (including emergency department visits or unscheduled outpatient visits). [Time frame: 30 days after surgery]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Other
Study locations
China · 1 center
- Cancer Institute and Hospital, Chinese Academy of Medical Sciences — Beijing
Identifiers
NCT: NCT07187154 · NCC3765