Clinical trial NCT03341377: Perioperative Symptom Study of Lung Cancer (CN-PRO-Lung 1)
Official title: An Observational Study for Establishing the Patient-reported Outcome-based Perioperative Symptom Management Cohort in Patients With Lung Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Patient-reported Outcomes
Keywords: utility parameter
patient-reported outcome
perioperative symptom management
lung cancer
Lead sponsor: Sichuan Cancer Hospital and Research Institute
Sponsor class: OTHER
Collaborators: name: M.D. Anderson Cancer Center
name: Sichuan Cancer Hospital and Research Institute
name: Zigong No.1 Peoples Hospital
name: Jiangyou People's Hospital
name: Chengdu Third People's Hospital
name: Chengdu Seventh People's Hospital
name: Dazhu County People's Hospital
First posted: 2017-11-14
Enrollment: 512
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Lung cancer patients planning to undergo surgery

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Perioperative symptom burden (severity, freqency and impact on daily functioning) measured by MDASI-LC
timeFrame: less than 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Chengdu
country: China
facility: Sichuan Cancer Hospital and Research Institute
state: Sichuan
city: Chengdu
country: China
facility: Chengdu Seventh People's Hospital
state: Sichuan
city: Chengdu
country: China
facility: Chengdu Third People's Hospital
state: Sichuan
city: Dazhou
country: China
facility: Dazhu County People's Hospital
state: Sichuan
city: Jiangyou
country: China
facility: Jiangyou People's Hospital
state: Sichuan
city: Zigong
country: China
facility: Zigong First People's Hospital
state: Sichuan
Study officials:
affiliation: Sichuan Cancer Hospital and Research Institute
name: Xiaojun Yang, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.