Dynamic Follow-up of Symptoms Based on Patient-reported Outcomes in Immunotherapy for Esophageal Cancer: a Prospective Multicentre Cohort Study (SPRING)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Enrollment
- 220
- Locations
- 1
- Primary Endpoint
- Prevalence and severity of adverse symptoms
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- 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
Outcomes
Primary Outcomes
Prevalence and severity of adverse symptoms
Time Frame: 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 Outcomes
- 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.)
Investigators
GuiBin Qiao
Professor of Medicine
Guangdong Provincial People's Hospital