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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Esophageal Cancer; Immunotherapy; Patient-reported Outcomes

• Study Type: Observational
• Enrollment (Estimated): 220

Contacts and Locations

• Study Contact: Name: Guibin Qiao, MD; Phone Number: 13602749153; Email: guibinqiao@126.com

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510080
      • Guangdong Provincial People's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

The target population of the study is patients with esophageal cancer who have received or are receiving immunotherapy-based regimens in various stages, including resectable, locally advanced, and advanced stages.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Monoimmunotherapy group
Chemoimmunotherapy group

What is the study measuring?

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.

Collaborators and Investigators

• Sponsor: Guangdong Provincial People's Hospital
• Collaborators: Shenzhen People's Hospital; Affiliated Cancer Hospital of Shantou University Medical College; Shenzhen Second People's Hospital; Shantou Central Hospital; First Affiliated Hospital of Shantou University Medical College; Sichuan Cancer Hospital and Research Institute; The First Affiliated Hospital of Guangdong Pharmaceutical University; Guangzhou Panyu Central Hospital; Shenzhen Third People's Hospital; Longgang District Central Hospital of Shenzhen; The General Hospital of Southern Theater Command
• Investigators: Principal Investigator: guibin Qiao, MD, Guangdong Provincial People's Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): September 10, 2023
• Primary Completion (Estimated): August 1, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: July 26, 2023
• First Submitted That Met QC Criteria: August 24, 2023
• First Posted (Actual): August 25, 2023

Study Record Updates

• Last Update Posted (Actual): August 25, 2023
• Last Update Submitted That Met QC Criteria: August 24, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: Immunotherapy; Esophageal Cancer; Patient-reported Outcomes; Symptom item bank
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Head and Neck Neoplasms; Esophageal Diseases; Esophageal Neoplasms
• Other Study ID Numbers: SPRING (Other Identifier: University Hospital A Coruña)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No