Perioperative Symptom Study of Lung Cancer (CN-PRO-Lung 1)

Patient-reported Outcomes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03341377
• Other study ID #: SCCHEC-02-2017-042
• Status: Completed
• Start date: November 21, 2017
• Est. completion date: January 1, 2020

Study information

• Verified date: October 2020
• Source: Sichuan Cancer Hospital and Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 512
• Est. completion date: January 1, 2020
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Lung Neoplasms
• Patient-reported Outcomes

Locations

Country	Name	City	State
China	Chengdu Seventh People's Hospital	Chengdu	Sichuan
China	Chengdu Third People's Hospital	Chengdu	Sichuan
China	Sichuan Cancer Hospital and Research Institute	Chengdu	Sichuan
China	Dazhu County People's Hospital	Dazhou	Sichuan
China	Jiangyou People's Hospital	Jiangyou	Sichuan
China	Zigong First People's Hospital	Zigong	Sichuan

Sponsors (8)

Lead Sponsor	Collaborator
Xiaojun Yang	Chengdu Seventh People's Hospital, Chengdu Third People's Hospital, Dazhu County People's Hospital, Jiangyou People's Hospital, M.D. Anderson Cancer Center, Sichuan Cancer Hospital and Research Institute, Zigong First People's Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Perioperative symptom burden (severity, freqency and impact on daily functioning) measured by MDASI-LC	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.	less than 6 weeks