A Multicenter, Cross-sectional Study on the Quality of Life in Long-term Survival Esophageal Cancer Patients After Radical Radiochemotherapy/Radiotherapy

This study is a multicenter cross-sectional survey of esophageal cancer patients who underwent radical chemoradiotherapy/radiotherapy from July 2017 to July 2020 in various medical centers, and who survived without disease progression at the time of the survey. The purpose of this study is to evaluate the current quality of life, as well as the incidence of long-term toxic side effects, nutritional status, and psychological status of esophageal cancer patients cured by radiotherapy.

Study Overview

• Status: Not yet recruiting
• Conditions: Assessing the Current Quality of Life Status of Esophageal Cancer Patients Who Have Undergone Radical Chemoradiotherapy/Radiotherapy and Long-term Survival
• Intervention / Treatment: Other: questionnaire investigation

• Study Type: Observational
• Enrollment (Estimated): 1000

Contacts and Locations

Study Locations

• China
  • Tianjin
    • Tianjin, Tianjin, China, 300000
      • Tianjin Medical University Cancer Institute & Hospital
      • Contact: Qingsong Pang, PHD; Phone Number: +86-22-23340123-1121

Participation Criteria

Eligibility Criteria

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

• Sampling Method: Non-Probability Sample

Study Population

The age at the time of radiotherapy is between 18-75 years old, and the age at the time of investigation is<80 years old;

• Histologically confirmed esophageal squamous cell carcinoma without undergoing surgical resection;
• Received radical chemoradiotherapy/radiotherapy from July 2017 to July 2020, currently alive and without disease progression;
• Radiotherapy dose ≥ 45Gy.

Description

Inclusion Criteria:

• Voluntarily accept this survey and research;
• The age at the time of radiotherapy is between 18-75 years old, and the age at the time of investigation is<80 years old;
• Histologically confirmed esophageal squamous cell carcinoma without undergoing surgical resection;
• Received radical chemoradiotherapy/radiotherapy from July 2017 to July 2020, currently alive and without disease progression;
• Radiotherapy dose ≥ 45Gy.

Exclusion Criteria:

• Patients who do not cooperate with this survey;
• Patients who have died at the time of investigation;
• Patients who experience tumor progression within the time frame from the end of radiotherapy to receiving this survey;
• Patients diagnosed with other malignant tumors within the time frame from the end of radiotherapy to receiving this survey;
• Patients with incorrect contact information and missing visits

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Quality of Life Assessment survey	Two years after the end of radiotherapy

Collaborators and Investigators

• Sponsor: Tianjin Medical University Cancer Institute and Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): August 1, 2023
• Primary Completion (Estimated): May 1, 2024
• Study Completion (Estimated): July 1, 2024

Study Registration Dates

• First Submitted: April 13, 2023
• First Submitted That Met QC Criteria: April 24, 2023
• First Posted (Actual): April 25, 2023

Study Record Updates

• Last Update Posted (Actual): July 7, 2023
• Last Update Submitted That Met QC Criteria: July 6, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• 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: bc2022181

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