Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| 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 |
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Monoimmunotherapy group | |||
| Chemoimmunotherapy group |
Not provided
| 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. |
| 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. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Guibin Qiao, MD | Contact | 13602749153 | guibinqiao@126.com |
| Name | Affiliation | Role |
|---|---|---|
| Guibin Qiao, MD | Guangdong Provincial People's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Guangdong Provincial People's Hospital | Guangzhou | Guangdong | 510080 | China |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Shantou Central Hospital | OTHER |
| Affiliated Cancer Hospital of Shantou University Medical College | OTHER |
| Shenzhen Second People's Hospital | OTHER |
| Longgang District People's 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 |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D004938 | Esophageal Neoplasms |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D004066 | Digestive System Diseases |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
Not provided
Not provided