Epidemiology and Psychosocial Evaluation of Inpatient With Lung Opacity

NCT ID: NCT03498768

Last Updated: 2018-04-17

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 300 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-04-30
• Study Completion Date: 2019-06-30

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.

Conditions

Lung Cancer; Psychological Distress

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Inpatients with lung nodules

All inpatients in our department are invited to finish the questionnaire at inpatient education on the first day of hospitalization as the baseline date, then they are followed up by phone call to reevaluate their psychosocial status at 6 months and 1 year after the surgery.

Questionnaire Administration

Intervention Type: OTHER

Subjects will be invited to complete a detailed questionnaire regarding personal information, known risk factors for lung cancer and psychological status.

Interventions

Questionnaire Administration

Subjects will be invited to complete a detailed questionnaire regarding personal information, known risk factors for lung cancer and psychological status.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Beijing Haidian Hospital

OTHER

Sponsor Role: collaborator

Peking University People's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Jun Wang

Principal Investigator, Clinical Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jun Wang, MM

Role: PRINCIPAL_INVESTIGATOR

Peking University People's Hospital

Locations

Peking University People'S Hospital

Beijing, Beijing Municipality, China

Countries

China

Central Contacts

Jun Wang, MM

Role: CONTACT

xiongwai@263.net

+8601088326650

Rongxin Xiao, MD

Role: CONTACT

rainbowxinxinxin@163.com

+8618910700234

Other Identifiers

PKUPH-DTS

Identifier Type: -

Identifier Source: org_study_id