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NCT Number: NCT03341377

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

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.

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Key information

Conditions

Patient-reported Outcomes Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Chengdu Seventh People's Hospital, Chengdu, Sichuan, China

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Xiaojun Yang

Other

Collaborators

  • 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 No.1 Peoples Hospital

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2019
Study completion
2020
First posted
Nov 14, 2017
Registry last updated
Oct 28, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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