The Level of Patient Participation in Lung and Esophageal Cancer Patients Treated With Definitive Radiochemotherapy.

A Prospective Observational Study on the Level of Patient Participation in Lung and Esophageal Cancer Patients Treated With Definitive Radiochemotherapy.

This study aims to assess the level of participation of thoracic cancer patients undergoing definitive radiotherapy and chemotherapy ± immunotherapy in their medical processes and the association between the level of participation and patients' side effects, quality of life, and long-term survival. Additionally, this study will rate the level of participation from both the patients' and medical staff's perspectives and will compare the differences in ratings from these two viewpoints, as well as their impact on treatment outcomes.

Study Overview

• Status: Recruiting
• Conditions: Esophageal Cancer; Lung Cancer

• Study Type: Observational
• Enrollment (Estimated): 500

Contacts and Locations

• Study Contact: Name: Bo Qiu; Phone Number: +862087343031; Email: qiubo@sysucc.org.cn

Study Locations

• China
  • Guangzhou, China, 510060
    • Recruiting
    • Sun Yat-sen University
    • Contact: Bo Qiu, Ph.D; Phone Number: +862087343031; Email: qiubo@sysucc.org.cn
    • Contact: Hui Liu, Ph.D; Phone Number: +862087343031; Email: liuhui@sysucc.org.cn
    • Principal Investigator: Hui Liu, Ph.D

Participation Criteria

Eligibility Criteria

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

• Sampling Method: Probability Sample

Study Population

Patients with locally advanced non-small cell lung cancer, limited-stage small cell lung cancer, or esophageal cancer

Description

Inclusion Criteria:

• Locally advanced non-small cell lung cancer, limited-stage small cell lung cancer, and esophageal cancer.
• Planned to undergo definitive chemoradiotherapy ± immunotherapy;
• Males or females aged 18 to 75;
• Able to communicate with medical staff.

Exclusion Criteria: Patients with cognitive impairments.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Observational group; Patients undergoing definitive radiochemotherapy ± immunotherapy will be assessed about the level of participation in their medical processes.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of >=Grade 3 toxicities	The percentage of patients who develop >=Grade 3 toxicities	2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall survival	2-year survival rate	2 years
Progression-free survival	2-year progression-free survival rate	2 years

Collaborators and Investigators

• Sponsor: Sun Yat-sen University

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2022
• Primary Completion (Estimated): May 30, 2027
• Study Completion (Estimated): May 30, 2027

Study Registration Dates

• First Submitted: August 25, 2023
• First Submitted That Met QC Criteria: August 25, 2023
• First Posted (Actual): August 31, 2023

Study Record Updates

• Last Update Posted (Estimated): December 10, 2024
• Last Update Submitted That Met QC Criteria: December 5, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Head and Neck Neoplasms; Esophageal Diseases; Esophageal Neoplasms
• Other Study ID Numbers: 2023-FXY-017

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No