NCT03341377

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
• Phase: —
• Study type: Observational
• Enrollment: 512 (actual)
• Sponsor: Xiaojun Yang · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Patient-reported Outcomes

Timeline

• Start date: 2017-11-21
• Primary completion: 2019-12-31
• Completion: 2020-01-01
• First posted: 2017-11-14
• Last updated: 2020-10-28

Locations

6 sites across 1 country: China