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Perioperative Symptom Study of Lung Cancer (CN-PRO-Lung 1)

Sponsor
Xiaojun Yang (Other)
Overall Status
Completed
CT.gov ID
NCT03341377
Collaborator
M.D. Anderson Cancer Center (Other), Sichuan Cancer Hospital and Research Institute (Other), Zigong First People's Hospital (Other), Jiangyou People's Hospital (Other), Chengdu Third People's Hospital (Other), Chengdu Seventh People's Hospital (Other), Dazhu County People's Hospital (Other)
512
Enrollment
6
Locations
25.3
Actual Duration (Months)
85.3
Patients Per Site
3.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Investigators propose a multicenter prospective observational cohort study to develop and validate essential technical parameters for establishing the patient-reported outcome-based perioperative symptom management cohort in patients with lung cancer. With at least 300 patients with initial diagnosis of lung cancer and scheduled for surgery, this study will administer symptom assessments (MDASI-LC) and quality of life assessments (SIQOL) before surgery (typically within 3 days before surgery), daily after surgery (in hospital ≤ 14 days), and weekly after discharge, up to 4 weeks (±3 days) or the start day of postoperative oncologic treatment. In the upgraded research protocol, symptom and quality of life assessments (every 3 month for 1 year, every 6 month for 2-3 year, every 12 month for 4-5 year), as well as the follow-up of clinical outcomes will continue until 5 years after surgery.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    512 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    An Observational Study for Establishing the Patient-reported Outcome-based Perioperative Symptom Management Cohort in Patients With Lung Cancer
    Actual Study Start Date :
    Nov 21, 2017
    Actual Primary Completion Date :
    Dec 31, 2019
    Actual Study Completion Date :
    Jan 1, 2020

    Arms and Interventions

    Arm Intervention/Treatment
    Lung cancer surgical patients

    Patient-reported symptom assessments in patients undergoing lung cancer surgery.

    Outcome Measures

    Primary Outcome Measures

    1. Perioperative symptom burden (severity, freqency and impact on daily functioning) measured by MDASI-LC [less than 6 weeks]

      We will use MD Anderson Symptom Inventory lung cancer module (MDASI-LC) to longitudinally assess the perioperative symptom burden for lung cancer patients. The symptom burden will be profiled as symptom severity, frequency of moderate to severe symptom and its interference with daily functioning.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    1. Be pathologically or clinically diagnosed as primary lung cancer before surgery;

    2. Plan to undergo a surgical procedure.

    Exclusion Criteria:

    1. Aged younger than 18;

    2. Diagnosis of cognitive impairment or unable to understand the study requirements.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Sichuan Cancer Hospital and Research Institute Chengdu Sichuan China 610041
    2 Chengdu Seventh People's Hospital Chengdu Sichuan China
    3 Chengdu Third People's Hospital Chengdu Sichuan China
    4 Dazhu County People's Hospital Dazhou Sichuan China
    5 Jiangyou People's Hospital Jiangyou Sichuan China 621700
    6 Zigong First People's Hospital Zigong Sichuan China 643000

    Sponsors and Collaborators

    • Xiaojun Yang
    • M.D. Anderson Cancer Center
    • Sichuan Cancer Hospital and Research Institute
    • Zigong First People's Hospital
    • Jiangyou People's Hospital
    • Chengdu Third People's Hospital
    • Chengdu Seventh People's Hospital
    • Dazhu County People's Hospital

    Investigators

    • Principal Investigator: Xiaojun Yang, MD, Sichuan Cancer Hospital and Research Institute

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Xiaojun Yang, Clinical Professor and Principal Investigator, Sichuan Cancer Hospital and Research Institute
    ClinicalTrials.gov Identifier:
    NCT03341377
    Other Study ID Numbers:
    • SCCHEC-02-2017-042
    First Posted:
    Nov 14, 2017
    Last Update Posted:
    Oct 28, 2020
    Last Verified:
    Oct 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Xiaojun Yang, Clinical Professor and Principal Investigator, Sichuan Cancer Hospital and Research Institute
    utility parameter
    patient-reported outcome
    perioperative symptom management
    lung cancer
    Additional relevant MeSH terms:
    Lung Neoplasms

    Study Results

    No Results Posted as of Oct 28, 2020