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

Sichuan University

Status and phase: Not yet enrolling; Phase 3

Conditions: Esophageal Cancer (EsC)

Treatments: Other: Conventional Management; Other: Patient-Reported Outcome (PRO)-Based Symptom Management

Study type: Interventional

Funder types: Other

Identifiers

NCT07211009

ESO-PROSM

Details and patient eligibility

About

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.

Enrollment: 240 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Age 18-75 years.
2. Pathologically confirmed esophageal cancer.
3. Planned to undergo curative (radical) surgical resection.
4. R0 resection.
5. Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤ 1.
6. Adequate function of major organs.
7. Willing to complete questionnaire surveys.
8. Voluntarily agrees to participate and signs the informed consent form.
9. Good compliance and able to complete follow-up as scheduled.

Exclusion criteria

1. Human immunodeficiency virus (HIV) infection.
2. Psychiatric disorder.
3. 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).
4. Patient ultimately did not undergo curative (radical) surgical resection.
5. Any unstable systemic disease (including active, uncontrolled gastrointestinal ulcer; active infection; grade 4 hypertension; unstable angina; congestive heart failure; unstable cerebrovascular disease; thrombotic disease; hepatic, renal, or metabolic disease; or unhealed fracture/wound as determined by the surgeon).
6. Difficulty in communication or inability to comply with long-term follow-up.
7. Any other condition deemed unsuitable by the investigator.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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240 participants in 2 patient groups

PRO Symptom Management Group

Experimental group

Description:

In the PRO arm, participants receive postoperative, PRO-based symptom management: when any target symptom score in the self-report system reaches or exceeds the predefined intervention threshold (≥2 points, indicating moderate to very severe), the system sends a real-time alert to the surgeon. The surgeon implements an intervention within the specified time window according to symptom severity. After discharge, follow-up and management are conducted via WeChat, text message, or telephone. All interventions are formulated based on relevant literature, guidelines, and expert consensus.

Treatment:

Other: Patient-Reported Outcome (PRO)-Based Symptom Management

Conventional Management Group

Active Comparator group

Description:

In the control arm, participants receive conventional postoperative symptom management. The electronic questionnaires use the same content and time points as the intervention arm, but reported symptoms do not trigger alerts, and surgeons cannot view the scores. During hospitalization, surgeons typically assess symptom severity based on patient reports during morning and afternoon rounds and manage care according to the same guidelines and consensus as the intervention arm. After discharge, no proactive symptom management is provided unless the patient actively seeks medical assistance.

Treatment:

Other: Conventional Management