Patient-Reported Symptom Care Versus Usual Care After Esophageal Cancer Surgery: A Single-Center Phase 3 Randomized Trial

Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-75
SponsorSichuan University

About this trial

Symptom management is fundamental to clinical care, and symptom monitoring is an effective means to detect potential adverse events early and prevent serious complications. Extensive studies show that symptom management based on patient-reported outcomes (PROs) can reduce symptom burden, improve functional status and quality of life, lower emergency visits and readmissions, and even prolong survival. However, in the field of esophageal cancer surgery, prospective clinical studies assessing the feasibility of postoperative PRO-based symptom management remain lacking. This project proposes a randomized controlled trial (RCT) in China to systematically evaluate the effectiveness and feasibility of PRO-based symptom management after esophageal cancer surgery. Through this clinical study, we aim to assess both the impact and the implementability of introducing a proactive, patient-centered PRO symptom-management model into esophageal surgical care.

Eligibility criteria

Qualifiers

Age 18-75 years.

Pathologically confirmed esophageal cancer.

Planned to undergo curative (radical) surgical resection.

R0 resection.

Disqualifiers

Human immunodeficiency virus (HIV) infection.

Psychiatric disorder.

Any other malignancy within the past 5 years (except completely cured carcinoma in situ of the cervix or basal cell/squamous cell carcinoma of the skin).

Patient ultimately did not undergo curative (radical) surgical resection.

Trial design

Treatments tested in this trial

  • Patient-Reported Outcome (PRO)-Based Symptom Management
  • Conventional Management

Treatment groups

240 Participants
are divided into 2 treatment groups

Locations

This trial has no locations

Sponsors and collaborators