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Epidemiology and Psychosocial Evaluation of Inpatient With Lung Opacity

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ClinicalTrials.gov Identifier: NCT03498768
Recruitment Status : Not yet recruiting
First Posted : April 17, 2018
Last Update Posted : April 17, 2018
Sponsor:
Collaborator:
Beijing Haidian Hospital
Information provided by (Responsible Party):
Jun Wang, Peking University People's Hospital

Tracking Information
First Submitted Date April 5, 2018
First Posted Date April 17, 2018
Last Update Posted Date April 17, 2018
Estimated Study Start Date April 2018
Estimated Primary Completion Date June 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: April 12, 2018)
  • Risk factors for Chinese lung cancer patients [ Time Frame: 1.5 years ]
    Patients with lung nodules are invited to fill in a questionnaire including personal information, smoking history, medical history, their diet and lifestyle habits, family history of malignant neoplasm, this procedure is finished during inpatient education before the operation. After the operation, we analyze the factors and patients' pathology results to figure out the risk factors for Chinese lung cancer patients.
  • Psychological status of patients with lung nodules [ Time Frame: 1.5 years ]
    Patients with lung nodules are invited to fill in the Hospital Anxiety and Depression Scale (HADS) during inpatient education. Patients are thus grouped depending on whether they have indication for biopsy or operation according to the NCCN guideline for lung nodules management. As a result, patients who accept surveillance long enough or have proper indication for operation are one group, patients who stop surveillance and choose to get operation "ahead of time" are the other group. The level of negative emotion would be analyzed and compared afterwards.
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: April 12, 2018)
Life quality of patients with lung nodules [ Time Frame: 1.5 years ]
Patients with lung nodules are invited to fill in the MOS item short from health survey (SF-36) scale during inpatient education. Patients are thus grouped depending on whether they have indication for biopsy or operation according to the NCCN guideline for lung nodules management. As a result, patients who accept surveillance long enough or have proper indication for operation are one group, patients who stop surveillance and choose to get operation "ahead of time" are the other group. The quality of life would be analyzed and compared afterwards.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Epidemiology and Psychosocial Evaluation of Inpatient With Lung Opacity
Official Title Epidemiology and Psychosocial Evaluation of Inpatient With Lung Opacity :a Prospective Multicentre Study
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.

Study Type Observational [Patient Registry]
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration 6 Months
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population Inpatients aged between 18-80, tolerant to surgery with accessible pathology outcome are eligible.
Condition
  • Lung Cancer
  • Psychological Distress
Intervention Other: Questionnaire Administration
Subjects will be invited to complete a detailed questionnaire regarding personal information, known risk factors for lung cancer and psychological status.
Study Groups/Cohorts 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.
Intervention: Other: Questionnaire Administration
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Not yet recruiting
Estimated Enrollment
 (submitted: April 12, 2018)
300
Original Estimated Enrollment Same as current
Estimated Study Completion Date June 2019
Estimated Primary Completion Date June 2019   (Final data collection date for primary outcome measure)
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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts
Contact: Jun Wang, MM +8601088326650 xiongwai@263.net
Contact: Rongxin Xiao, MD +8618910700234 rainbowxinxinxin@163.com
Listed Location Countries China
Removed Location Countries  
 
Administrative Information
NCT Number NCT03498768
Other Study ID Numbers PKUPH-DTS
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party Jun Wang, Peking University People's Hospital
Study Sponsor Peking University People's Hospital
Collaborators Beijing Haidian Hospital
Investigators
Principal Investigator: Jun Wang, MM Peking University People's Hospital
PRS Account Peking University People's Hospital
Verification Date April 2018