NCT03341377

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
512

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2017

Typical duration for all trials

Geographic Reach
1 country

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 8, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 14, 2017

Completed
7 days until next milestone

Study Start

First participant enrolled

November 21, 2017

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2019

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2020

Completed
Last Updated

October 28, 2020

Status Verified

October 1, 2020

Enrollment Period

2.1 years

First QC Date

November 8, 2017

Last Update Submit

October 25, 2020

Conditions

Patient-reported Outcomes

Keywords

utility parameterpatient-reported outcomeperioperative symptom managementlung cancer

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

Lung cancer surgical patients

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Lung cancer patients planning to undergo surgery

You may qualify if:

  • Be pathologically or clinically diagnosed as primary lung cancer before surgery;
  • Plan to undergo a surgical procedure.

You may not qualify if:

  • Aged younger than 18;
  • Diagnosis of cognitive impairment or unable to understand the study requirements.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Sichuan Cancer Hospital and Research Institute

Chengdu, Sichuan, 610041, China

Location

Chengdu Seventh People's Hospital

Chengdu, Sichuan, China

Location

Chengdu Third People's Hospital

Chengdu, Sichuan, China

Location

Dazhu County People's Hospital

Dazhou, Sichuan, China

Location

Jiangyou People's Hospital

Jiangyou, Sichuan, 621700, China

Location

Zigong First People's Hospital

Zigong, Sichuan, 643000, China

Location

Related Publications (3)

  • Liao J, Hu X, Wei X, Dai W, Yu H, Tian X, Wang Y, Qin Q, Xu N, Li Y, Li Q, Shi Q, Liu X. Sex-related differences in postoperative patient-reported outcomes among lung cancer patients: a multicenter cohort study. BMC Cancer. 2025 Apr 29;25(1):800. doi: 10.1186/s12885-025-14191-z.

    PMID: 40301835DERIVED

  • Wei X, Yu H, King-Kallimanis B, Liu Y, Huang L, Dai W, Yang D, Zhou X, Li Q, Shi Q. Long-Term Function Recovery Following Upper Versus Lower Lobectomy for Lung Cancer: A Multicenter Longitudinal Cohort Study. Thorac Cancer. 2025 Jan;16(1):e15505. doi: 10.1111/1759-7714.15505. Epub 2024 Dec 13.

    PMID: 39670353DERIVED

  • 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.

    PMID: 31662377DERIVED

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Xiaojun Yang, MD

    Sichuan Cancer Hospital and Research Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Clinical Professor and Principal Investigator

Study Record Dates

First Submitted

November 8, 2017

First Posted

November 14, 2017

Study Start

November 21, 2017

Primary Completion

December 31, 2019

Study Completion

January 1, 2020

Last Updated

October 28, 2020

Record last verified: 2020-10

Data Sharing

IPD Sharing
Will not share

Locations

CN(6)