Perioperative Symptom Study of Lung Cancer (CN-PRO-Lung 1)
- Conditions
- Patient-reported Outcomes
- Registration Number
- NCT03341377
- Lead Sponsor
- Xiaojun Yang
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 512
- Be pathologically or clinically diagnosed as primary lung cancer before surgery;
- Plan to undergo a surgical procedure.
- Aged younger than 18;
- Diagnosis of cognitive impairment or unable to understand the study requirements.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Perioperative symptom burden (severity, freqency and impact on daily functioning) measured by MDASI-LC 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (6)
Jiangyou People's Hospital
🇨🇳Jiangyou, Sichuan, China
Zigong First People's Hospital
🇨🇳Zigong, Sichuan, China
Sichuan Cancer Hospital and Research Institute
🇨🇳Chengdu, Sichuan, China
Chengdu Seventh People's Hospital
🇨🇳Chengdu, Sichuan, China
Chengdu Third People's Hospital
🇨🇳Chengdu, Sichuan, China
Dazhu County People's Hospital
🇨🇳Dazhou, Sichuan, China