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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)

Sponsor
Guangdong Provincial People's Hospital (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06012318
Collaborator
First Affiliated Hospital of Shantou University Medical College (Other), The General Hospital of Southern Theater Command (Other), The First Affiliated Hospital of Guangdong Pharmaceutical University (Other), Shantou Central Hospital (Other), Affiliated Cancer Hospital of Shantou University Medical College (Other), Shenzhen Second People's Hospital (Other), Longgang District Central Hospital of Shenzhen (Other), Shenzhen Third People's Hospital (Other), Shenzhen People's Hospital (Other), Sichuan Cancer Hospital and Research Institute (Other), Guangzhou Panyu Central Hospital (Other)
220
Enrollment
1
Location
15.7
Anticipated Duration (Months)
14
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    220 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Dynamic Follow-up of Symptoms Based on Patient-reported Outcomes in Immunotherapy for Esophageal Cancer: a Prospective Multicentre Cohort Study (SPRING)
    Anticipated Study Start Date :
    Sep 10, 2023
    Anticipated Primary Completion Date :
    Aug 1, 2024
    Anticipated Study Completion Date :
    Dec 31, 2024

    Arms and Interventions

    Arm Intervention/Treatment
    Monoimmunotherapy group
    Chemoimmunotherapy group

    Outcome Measures

    Primary Outcome Measures

    1. Prevalence and severity of adverse symptoms [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.]

      Incidence and severity of adverse symptoms in esophageal cancer patients treated with immunotherapy

    Secondary Outcome Measures

    1. Trajectory of adverse symptoms [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.]

      Trajectory of adverse symptoms in esophageal cancer patients treated with immunotherapy

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 75 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Guangdong Provincial People's Hospital Guangzhou Guangdong China 510080

    Sponsors and Collaborators

    • Guangdong Provincial People's Hospital
    • First Affiliated Hospital of Shantou University Medical College
    • The General Hospital of Southern Theater Command
    • The First Affiliated Hospital of Guangdong Pharmaceutical University
    • Shantou Central Hospital
    • Affiliated Cancer Hospital of Shantou University Medical College
    • Shenzhen Second People's Hospital
    • Longgang District Central Hospital of Shenzhen
    • Shenzhen Third People's Hospital
    • Shenzhen People's Hospital
    • Sichuan Cancer Hospital and Research Institute
    • Guangzhou Panyu Central Hospital

    Investigators

    • Principal Investigator: Guibin Qiao, MD, Guangdong Provincial People's Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    GuiBin Qiao, Professor of Medicine, Guangdong Provincial People's Hospital
    ClinicalTrials.gov Identifier:
    NCT06012318
    Other Study ID Numbers:
    • SPRING
    First Posted:
    Aug 25, 2023
    Last Update Posted:
    Aug 25, 2023
    Last Verified:
    Aug 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by GuiBin Qiao, Professor of Medicine, Guangdong Provincial People's Hospital
    Esophageal Cancer
    Immunotherapy
    Patient-reported Outcomes
    Symptom item bank
    Additional relevant MeSH terms:
    Esophageal Neoplasms

    Study Results

    No Results Posted as of Aug 25, 2023