An Observational Study for Establishing the Patient-reported Outcome-based Perioperative Symptom Management Cohort in Patients With Lung Cancer
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Patient-reported Outcomes
- Sponsor
- Xiaojun Yang
- Enrollment
- 512
- Locations
- 6
- Primary Endpoint
- Perioperative symptom burden (severity, freqency and impact on daily functioning) measured by MDASI-LC
- Status
- Completed
- Last Updated
- 5 years ago
Overview
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.
Investigators
Xiaojun Yang
Clinical Professor and Principal Investigator
Sichuan Cancer Hospital and Research Institute
Eligibility Criteria
Inclusion Criteria
- •Be pathologically or clinically diagnosed as primary lung cancer before surgery;
- •Plan to undergo a surgical procedure.
Exclusion Criteria
- •Aged younger than 18;
- •Diagnosis of cognitive impairment or unable to understand the study requirements.
Outcomes
Primary Outcomes
Perioperative symptom burden (severity, freqency and impact on daily functioning) measured by MDASI-LC
Time Frame: less than 6 weeks
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.