NCT03498768

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2018

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2018

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

April 5, 2018

Completed
12 days until next milestone

First Posted

Study publicly available on registry

April 17, 2018

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2019

Completed
Last Updated

April 17, 2018

Status Verified

April 1, 2018

Enrollment Period

1.2 years

First QC Date

April 5, 2018

Last Update Submit

April 12, 2018

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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.

    1.5 years

  • 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.

    1.5 years

Secondary Outcomes (1)

  • Life quality of patients with lung nodules

    1.5 years

Study Arms (1)

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

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

Inpatients with lung nodules

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Inpatients aged between 18-80, tolerant to surgery with accessible pathology outcome are eligible.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peking University People'S Hospital

Beijing, Beijing Municipality, +86-010, China

Location

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Jun Wang, MM

    Peking University People's Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
6 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator, Clinical Professor

Study Record Dates

First Submitted

April 5, 2018

First Posted

April 17, 2018

Study Start

April 1, 2018

Primary Completion

June 1, 2019

Study Completion

June 1, 2019

Last Updated

April 17, 2018

Record last verified: 2018-04

Locations