Dynamic Follow-up of Symptoms Based on Patient-reported Outcomes in Immunotherapy for Esophageal Cancer: a Prospective Multicentre Cohort Study (SPRING)

Study Overview
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Brief Summary
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Immunotherapy shows satisfactory effectiveness and safety in patients with esophageal cancer. Immunotherapy-based regimens have a better survival benefit compared to previous chemotherapy and radiotherapy. Patient-reported outcomes (PRO) provide a reliable assessment of patients' functional status during treatment. However, the spectrum of symptoms in esophageal cancer patients receiving immunotherapy is uncertain, and there are no studies applying the symptom bank based on PRO to the immunotherapy model for esophageal cancer. In this prospective study, the investigators aimed to preliminarily screen for symptoms associated with immunotherapy for esophageal cancer through a systematic literature review and expert evaluation, and build a symptom item bank for esophageal cancer patients receiving immunotherapy. Adverse symptoms in esophageal cancer patients treated with immunotherapy were collected prospectively. The distribution and severity of the symptoms, as well as the trajectory of symptom change were further analyzed to demonstrate the validity and reliability of the symptom item bank. It would refine the spectrum of symptoms for esophageal cancer patients receiving immunotherapy and provide a foundation for assessing the specific symptom burden in patients with esophageal cancer receiving immunotherapy regimens.

Official Title
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Dynamic Follow-up of Symptoms Based on Patient-reported Outcomes in Immunotherapy for Esophageal Cancer: a Prospective Multicentre Cohort Study (SPRING)

Conditions
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Esophageal Cancer, Patient-reported Outcomes, Immunotherapy

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Pathologically confirmed resectable, locally advanced, advanced metastatic esophageal cancer Having received or undergoing an immunotherapy-based treatment regimen Age 18-75 years ECOG PS of 0-2 Adequate organ function Life expectancy > 6 months Participants are fully informed about the whole study and are willing to sign the informed consent Exclusion Criteria: Absence of immunotherapy regimen, or recieving radiotherapy. Presence of primary tumours elsewhere, such as gastric cancer, lung cancer or cervical cancer Severe organ function deterioration and intolerance to immunotherapy Pregnant or breast-feeding women Previous autoimmune disease Any other conditions that may affect patients' safety and compliance Psychological, family, social and other factors leading to inability to inform consent

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Monoimmunotherapy group<br> | |
| Chemoimmunotherapy group<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prevalence and severity of adverse symptoms | Incidence and severity of adverse symptoms in esophageal cancer patients treated with immunotherapy | Patients were evaluated from the beginning of immunochemotherapy to three weeks after completion of the last immunochemotherapy treatment. The total time for patient evaluation is less than 6 months. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Trajectory of adverse symptoms | Trajectory of adverse symptoms in esophageal cancer patients treated with immunotherapy | Patients were evaluated from the beginning of immunochemotherapy to three weeks after completion of the last immunochemotherapy treatment. The total time for patient evaluation is less than 6 months. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Esophageal Cancer, Immunotherapy, Patient-reported Outcomes, Symptom item bank