Clinical trial NCT06012318: Dynamic Follow-up of Symptoms Based on Patient-reported Outcomes in Immunotherapy for Esophageal Cancer: a Prospective Multicentre Cohort Study (SPRING)
Official title: Dynamic Follow-up of Symptoms Based on Patient-reported Outcomes in Immunotherapy for Esophageal Cancer: a Prospective Multicentre Cohort Study (SPRING)
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Esophageal Cancer
Patient-reported Outcomes
Immunotherapy
Keywords: Esophageal Cancer
Immunotherapy
Patient-reported Outcomes
Symptom item bank
Lead sponsor: Guangdong Provincial People's Hospital
Sponsor class: OTHER
Collaborators: name: First Affiliated Hospital of Shantou University Medical College
name: The General Hospital of Southern Theater Command
name: The First Affiliated Hospital of Guangdong Pharmaceutical University
name: Shantou Central Hospital
name: Affiliated Cancer Hospital of Shantou University Medical College
name: Shenzhen Second People's Hospital
name: Longgang District People's Hospital of Shenzhen
name: Shenzhen Third People's Hospital
name: Shenzhen People's Hospital
name: Sichuan Cancer Hospital and Research Institute
name: Guangzhou Panyu Central Hospital
First posted: 2023-08-25
Enrollment: 220
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Prevalence and severity of adverse symptoms
timeFrame: 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 outcomes:
measure: Trajectory of adverse symptoms
timeFrame: 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.
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Guangdong Provincial People's Hospital
state: Guangdong
Study officials:
affiliation: Guangdong Provincial People's Hospital
name: Guibin Qiao, MD
role: PRINCIPAL_INVESTIGATOR
References: