Clinical trial NCT03498768: Epidemiology and Psychosocial Evaluation of Inpatient With Lung Opacity
Official title: Epidemiology and Psychosocial Evaluation of Inpatient With Lung Opacity ：a Prospective Multicentre Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Lung Cancer
Psychological Distress
Lead sponsor: Peking University People's Hospital
Sponsor class: OTHER
Collaborators: name: Beijing Haidian Hospital
First posted: 2018-04-17
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Inpatients aged between 18-80, tolerant to surgery with accessible pathology outcome are eligible.

Brief summary: Lung cancer is one of the leading cause of cancer related death in China.Different from patients in the US, Chinese patients with lung nodules tend to be less related to smoking, and seem to be more willing to get operation despite of the doctors' suggestion of imaging surveillance.

This study is designed to figure out the risk factors for Chinese lung cancer patients and evaluate the psychosocial status of inpatients with lung nodules.

Detailed description: Smoking is the only determinate risk factor proposed by the NCCN（National Comprehensive Cancer Network） Clinical Practice Guidelines for lung cancer screening. However, it has been estimated that over half of Chinese female lung cancer patients are non-smokers. Thus it might be reasonable to take unique Chinese cooking habit and environment pollution into consideration when it comes to the risk factors for lung cancer in Chinese people.

Lung nodules are reported to exist in 25-70% patients who have undergone LDCT （Low-dose Computed Tomography）examination. However, the prevalence of malignant nodules is reported to be 1.1-3% by different researchers. Even in country with comprehensive medical consulting system and lung nodule management consensus, almost all patients assume their lung nodules to be malignant when detected by LDCT for the first time.The investigators noticed nearly 1/3 of the inpatients are determined to get operation despite the surgeons' suggestion of CT surveillance according to the NCCN guideline in Department of Thoracic surgery in Peking University People's Hospital. As there's no evidence suggesting lung nodules in Chinese people have more possibility of malignancy, the investigators would like to know whether those patients who choose to get operation "ahead of the guideline" has higher level of cancer distress, and figure out whether psychosocial factors should be taken into consideration of lung nodules management when living with an indeterminate tumor has added up to patients' negative emotion and reduced their quality of life.

The investigators do the survey on the first day of admission during the inpatient education, help patients fill in the questionnaire including personal information, smoking history, medical history, their diet and lifestyle habits, family history of malignant neoplasm, any past or current environmental exposures and psychological status.

Eligibility criteria: Inclusion Criteria:

* Inpatients in Department of Thoracic Surgery in Peking University People's Hospital and Beijing Haidian Hospital.
* Tolerant to surgery with accessible pathology outcome.
* Aged between 18-80.
* Signed Informed Consent Form.

Exclusion Criteria:

* Patients who have difficulty in reading and writing.
* Poor physical status without sufficient respiratory reserve to undergo surgery.
* Unaccessible for surveillance after surgery.
* Refuse to take part.
* Other circumstances which is deemed inappropriate for enrollment by the researchers.

Primary outcomes:
measure: Risk factors for Chinese lung cancer patients
timeFrame: 1.5 years
measure: Psychological status of patients with lung nodules
timeFrame: 1.5 years
Secondary outcomes:
measure: Life quality of patients with lung nodules
timeFrame: 1.5 years
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University People'S Hospital
state: Beijing
Study officials:
affiliation: Peking University People's Hospital
name: Jun Wang, MM
role: PRINCIPAL_INVESTIGATOR
References: