CClinicalTrials.gg
Status unknownNCT03498768Updated Apr 17, 2018

Epidemiology and Psychosocial Evaluation of Inpatient With Lung Opacity

An observational study in Lung Cancer and Psychological Distress, sponsored by Peking University People's Hospital. Status unknown at 1 site in China. Open to participants aged 18 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-04-17.

Sponsored by Peking University People's Hospital · Observational

The sponsor has not verified this record recently (last verified Apr 2018), so the status shown — last known as Not yet recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
300
Ages
18 Years to 80 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Lung Cancer
  • Psychological Distress
03

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
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.

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

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.
04

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
300 participants (estimated)
Target follow-up
6 Months
Patient registry
Yes

Groups and 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.

    Other: Questionnaire Administration

Interventions

  • OtherQuestionnaire Administration

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

05

What researchers measure

Primary outcomes

  1. Risk factors for Chinese lung cancer patients

    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.

    Time frame: 1.5 years

  2. Psychological status of patients with lung nodules

    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.

    Time frame: 1.5 years

Secondary outcomes

  1. Life quality of patients with lung nodules

    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.

    Time frame: 1.5 years

06

Study locations

1 site
  • Peking University People'S Hospital
    Beijing, Beijing +86-010, China
07

Registry details

Key details

Study ID
NCT03498768
Lead sponsor
Peking University People's Hospital
Collaborators
Beijing Haidian Hospital
Responsible party
Jun Wang (Principal Investigator, Clinical Professor, Peking University People's Hospital) — Principal investigator
First posted
Apr 17, 2018
Start date
Apr 2018 (estimated)
Primary completion
Jun 2019 (estimated)
Completion
Jun 2019 (estimated)
Last update
Apr 17, 2018

Study contacts

Jun Wang, MM
Contact
xiongwai@263.net
+8601088326650
Rongxin Xiao, MD
Contact
rainbowxinxinxin@163.com
+8618910700234
Jun Wang, MM
principal investigator · Peking University People's Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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