Lung CancerNCT03498768
Epidemiology and Psychosocial Evaluation of Inpatient With Lung Opacity
An observational study of Lung Cancer and Psychological Distress, run by Peking University People's Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Lung Cancer, Psychological Distress
- What is being tested?
- Questionnaire Administration
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- Apr 2018to Jun 2019
- How long will I take part?
- 6 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Inpatients aged between 18-80, tolerant to surgery with accessible pathology outcome are eligible.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Peking University People'S Hospital
Beijing, Beijing Municipality, +86-010
About this study
Official title: Epidemiology and Psychosocial Evaluation of Inpatient With Lung Opacity ：a Prospective Multicentre Study
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.
- Conditions
- Lung Cancer, Psychological Distress
- Being tested
- Questionnaire Administration
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Questionnaire AdministrationOther
Subjects will be invited to complete a detailed questionnaire regarding personal information, known risk factors for lung cancer and psychological status.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Questionnaire Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 1.5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2018
- Study startApr 2018 (estimated)
- Primary completionJun 2019 (estimated)
- Study completionJun 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- More trials run by Peking University People's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Peking University People's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Beijing Haidian Hospital
- Responsible party
- Principal investigator, Jun Wang, Peking University People's Hospital
- Investigators
- Jun Wang, MM, Principal investigator, Peking University People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03498768
- Sponsor's protocol ID
- PKUPH-DTS
- Status last verified
- Apr 2018
- First submitted
- 5 Apr 2018
- Last updated
- 17 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Epidemiology and Psychosocial Evaluation of Inpatient With Lung Opacity ：a Prospective Multicentre Study
- ClinicalTrials.gov ID
- NCT03498768
- Acronym / sponsor ID
- PKUPH-DTS
- Conditions
- Lung Cancer, Psychological Distress
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Peking University People's HospitalUniversity, hospital or other
- Collaborators
- Beijing Haidian Hospital
- Study start
- Apr 2018 (estimated)
- Primary completion
- Jun 2019 (estimated)
- Study completion
- Jun 2019 (estimated)
- First posted
- 17 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Inpatients with lung nodules | – | Other: Questionnaire AdministrationAll 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Inpatients aged between 18-80, tolerant to surgery with accessible pathology outcome are eligible.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Questionnaire AdministrationSubjects will be invited to complete a detailed questionnaire regarding personal information, known risk factors for lung cancer and psychological status. | Other | Inpatients with lung nodules |
Primary outcome
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.
1 secondary outcome
Life quality of patients with lung nodules
Time frame: 1.5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jun Wang, MM principal investigator
Peking University People's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lung Cancer and Psychological Distress, run by Peking University People's Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jun Wang, MM (+8601088326650, xiongwai@263.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Risk factors for Chinese lung cancer patients (time frame: 1.5 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2018.