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

Summary

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.

Conditions

• Esophageal Cancer
• Patient-reported Outcomes
• Immunotherapy

Sponsors & Collaborators

• First Affiliated Hospital of Shantou University Medical College

  collaborator OTHER

• The General Hospital of Southern Theater Command

  collaborator OTHER

• The First Affiliated Hospital of Guangdong Pharmaceutical University

  collaborator OTHER

• Shantou Central Hospital

  collaborator OTHER

• Affiliated Cancer Hospital of Shantou University Medical College

  collaborator OTHER

• Shenzhen Second People's Hospital

  collaborator OTHER

• Longgang District People's Hospital of Shenzhen

  collaborator OTHER

• Shenzhen Third People's Hospital

  collaborator OTHER

• Shenzhen People's Hospital

  collaborator OTHER

• Sichuan Cancer Hospital and Research Institute

  collaborator OTHER

• Guangzhou Panyu Central Hospital

  collaborator OTHER

• Guangdong Provincial People's Hospital

  lead OTHER

Principal Investigators

• Guibin Qiao, MD · Guangdong Provincial People's Hospital

Eligibility

Min Age

18 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-09-10

Primary Completion

2024-08-01

Completion

2024-12-31

Countries

• China

Study Locations