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

Sponsor
Sun Yat-sen University (Other)
Overall Status
Recruiting
CT.gov ID
NCT06019455
Collaborator
(none)
500
Enrollment
1
Location
59.9
Anticipated Duration (Months)
8.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    500 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    A Prospective Observational Study on the Level of Patient Participation in Lung and Esophageal Cancer Patients Treated With Definitive Radiochemotherapy.
    Actual Study Start Date :
    Jun 1, 2022
    Anticipated Primary Completion Date :
    May 30, 2027
    Anticipated Study Completion Date :
    May 30, 2027

    Arms and Interventions

    Arm Intervention/Treatment
    Observational group

    Patients undergoing definitive radiochemotherapy ± immunotherapy will be assessed about the level of participation in their medical processes.

    Outcome Measures

    Primary Outcome Measures

    1. Incidence of >=Grade 3 toxicities [2 years]

      The percentage of patients who develop >=Grade 3 toxicities

    Secondary Outcome Measures

    1. Overall survival [2 years]

      2-year survival rate

    2. Progression-free survival [2 years]

      2-year progression-free survival rate

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 75 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    1. Locally advanced non-small cell lung cancer, limited-stage small cell lung cancer, and esophageal cancer.

    2. Planned to undergo definitive chemoradiotherapy ± immunotherapy;

    3. Males or females aged 18 to 75;

    4. Able to communicate with medical staff.

    Exclusion Criteria:

    Patients with cognitive impairments.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Sun Yat-sen University Guangzhou China 510060

    Sponsors and Collaborators

    • Sun Yat-sen University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Hui Liu, Professor, Sun Yat-sen University
    ClinicalTrials.gov Identifier:
    NCT06019455
    Other Study ID Numbers:
    • 2023-FXY-017
    First Posted:
    Aug 31, 2023
    Last Update Posted:
    Aug 31, 2023
    Last Verified:
    Aug 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Esophageal Neoplasms

    Study Results

    No Results Posted as of Aug 31, 2023