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Epidemiology and Psychosocial Evaluation of Inpatient With Lung Opacity

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ClinicalTrials.gov Identifier: NCT03498768
Recruitment Status : Unknown
Verified April 2018 by Jun Wang, Peking University People's Hospital.
Recruitment status was:  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

Study Description
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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.


Condition or disease Intervention/treatment
Lung Cancer Psychological Distress Other: Questionnaire Administration

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 Design
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Study Type : Observational [Patient Registry]
Estimated Enrollment : 300 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 6 Months
Official Title: Epidemiology and Psychosocial Evaluation of Inpatient With Lung Opacity ：a Prospective Multicentre Study
Estimated Study Start Date : April 2018
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : June 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

Groups and Cohorts
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Group/Cohort Intervention/treatment
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.
 Other: Questionnaire Administration
Subjects will be invited to complete a detailed questionnaire regarding personal information, known risk factors for lung cancer and psychological status.


Outcome Measures
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Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. 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.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Inpatients aged between 18-80, tolerant to surgery with accessible pathology outcome are eligible.
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03498768


Contacts
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Contact: Jun Wang, MM +8601088326650 xiongwai@263.net
Contact: Rongxin Xiao, MD +8618910700234 rainbowxinxinxin@163.com

Locations
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China, Beijing
Peking University People'S Hospital
Beijing, Beijing, China, +86-010
Sponsors and Collaborators
Peking University People's Hospital
Beijing Haidian Hospital
Investigators
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Principal Investigator: Jun Wang, MM Peking University People's Hospital
More Information
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Additional Information:

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Responsible Party: Jun Wang, Principal Investigator, Clinical Professor, Peking University People's Hospital
ClinicalTrials.gov Identifier: NCT03498768    
Other Study ID Numbers: PKUPH-DTS
First Posted: April 17, 2018    Key Record Dates
Last Update Posted: April 17, 2018
Last Verified: April 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No