CI

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ClinicalIndex Comparison Record
N/ACompleted· 512 enrolled
Drug / intervention
Not specified
Likely dose
Not stated in record
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Search/NCT03341377
NCT03341377N/ACompleted

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

Xiaojun Yang·observational·Posted Nov 14, 2017·Updated Oct 28, 2020

In Brief

An observational study for Patient-reported Outcomes. Completed, enrolled 512 participants across 6 sites.

Detailed 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.

Study Details

Timeline

N/ACompletedFinished
201820192020202120222023202420252026
First PostedNov 14, 2017
Enrollment StartNov 21, 2017
Primary CompletionDec 31, 2019
Study CompletionJan 1, 2020
TodayJul 2, 2026
Enrollment to primary: 2.1 yearsPosted 8.6 years ago