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

An Observational Study for Establishing the Patient-reported Outcome-based Perioperative Symptom Management Cohort in Patients With Lung Cancer

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.

Study Overview

• Status: Completed
• Conditions: Patient-reported Outcomes

• Study Type: Observational
• Enrollment (Actual): 512

Contacts and Locations

Study Locations

• China
  • Sichuan
    • Chengdu, Sichuan, China, 610041
      • Sichuan Cancer Hospital and Research Institute
    • Chengdu, Sichuan, China
      • Chengdu Seventh People's Hospital
    • Chengdu, Sichuan, China
      • Chengdu Third People's Hospital
    • Dazhou, Sichuan, China
      • Dazhu County People's Hospital
    • Jiangyou, Sichuan, China, 621700
      • Jiangyou People's Hospital
    • Zigong, Sichuan, China, 643000
      • Zigong First People's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Lung cancer patients planning to undergo surgery

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Lung cancer surgical patients; Patient-reported symptom assessments in patients undergoing lung cancer surgery.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Perioperative symptom burden (severity, freqency and impact on daily functioning) measured by MDASI-LC	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.	less than 6 weeks

Collaborators and Investigators

• Sponsor: Xiaojun Yang
• Collaborators: M.D. Anderson Cancer Center; Sichuan Cancer Hospital and Research Institute; Chengdu Third People's Hospital; Zigong No.1 Peoples Hospital; Jiangyou 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

Publications and helpful links

General Publications

• Dai W, Xie S, Zhang R, Wei X, Wu C, Zhang Y, Feng W, Liao X, Mu Y, Zhou H, Cheng X, Jiang Y, He J, Li Q, Yang X, Shi Q. Developing and validating utility parameters to establish patient-reported outcome-based perioperative symptom management in patients with lung cancer: a multicentre, prospective, observational cohort study protocol. BMJ Open. 2019 Oct 28;9(10):e030726. doi: 10.1136/bmjopen-2019-030726.

Study record dates

Study Major Dates

• Study Start (Actual): November 21, 2017
• Primary Completion (Actual): December 31, 2019
• Study Completion (Actual): January 1, 2020

Study Registration Dates

• First Submitted: November 8, 2017
• First Submitted That Met QC Criteria: November 10, 2017
• First Posted (Actual): November 14, 2017

Study Record Updates

• Last Update Posted (Actual): October 28, 2020
• Last Update Submitted That Met QC Criteria: October 25, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Keywords: lung cancer; patient-reported outcome; utility parameter; perioperative symptom management
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms
• Other Study ID Numbers: SCCHEC-02-2017-042

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