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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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03341377
Enrollment
512
Registered
2017-11-14
Start date
2017-11-21
Completion date
2020-01-01
Last updated
2020-10-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patient-reported Outcomes

Keywords

utility parameter, patient-reported outcome, perioperative symptom management, lung cancer

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.

Interventions

None listed

Sponsors

M.D. Anderson Cancer Center
CollaboratorOTHER
Sichuan Cancer Hospital and Research Institute
CollaboratorOTHER
Zigong No.1 Peoples Hospital
CollaboratorOTHER
Jiangyou People's Hospital
CollaboratorUNKNOWN
Chengdu Third People's Hospital
CollaboratorUNKNOWN
Chengdu Seventh People's Hospital
CollaboratorUNKNOWN
Dazhu County People's Hospital
CollaboratorUNKNOWN
Xiaojun Yang
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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.

Design outcomes

Primary

MeasureTime frameDescription
Perioperative symptom burden (severity, freqency and impact on daily functioning) measured by MDASI-LCless than 6 weeksWe 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.

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 2, 2026