Lung NeoplasmsLife-ScoreNCT06218901
Association of Psychological Distress in Patients With Lung Cancer
An observational study of Lung Neoplasms and Psychological Distress, run by Shanghai Chest Hospital at 1 site in China.
Trial summary
Psychological distress is a multi-factorial experience of a psychological, social, spiritual, and/or physical nature that may interfere with one's ability to cope effectively with cancer, physical symptoms and treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Neoplasms, Psychological Distress, Prognosis Factors
- What is being tested?
- immunotherapy and Targeted Therapy Agent
- How many people
- 500 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2016to 31 Dec 2028
- How long will I take part?
- 3 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- Adult, Older adult
Study population: Participants with lung cancer are with the standard treatment and/or are enrolled in the clinical trials.
Who may be able to join
- Histologically proven diagnosis of lung cancer
- 18 years of age or older
- Ability to understand and the willingness to sign a written informed consent document
Who cannot join
- Not willing to participate in this clinical trial
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Shanghai Chest Hospital
Shanghai, Shanghai Municipality, 200030
Xiaomin Niu, (86) 21 22200000 ext. 3703, ar_tey@hotmail.com
Xiaomin Niu
About this study
Official title: the Association of Psychological Distress in Patients With Advanced Lung Cancer Treated With Immunotherapy or Targeted Therapy
Psychological distress is a multi-factorial experience of a psychological, social, spiritual, and/or physical nature that may interfere with one's ability to cope effectively with cancer, physical symptoms and treatment. Psychological distress is common and affects the efficacy and prognosis of patients with lung cancer. The systematic anti-tumor therapy may effectively relieve psychological distress including anxiety, depression, and fatigue in patients with advanced lung cancer, the relief of the psychological distress can in turn improve the therapeutic effect.
In summary, this study is to explore the associations of (dynamic) psychological stress with the efficacy and survival of anti-tumor therapy including immunotherapy and targeted therapy for advanced lung cancer patients.
- Conditions
- Lung Neoplasms, Psychological Distress, Prognosis Factors, Lifestyle, Healthy, IMMUNOTHERAPY, Targeted Molecular Therapy
- Being tested
- immunotherapy, Targeted Therapy Agent
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
immunotherapyDrug
Targeted Therapy AgentDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response rate (ORR)
Collect detailed clinical information on patients with SCLC via the electronic medical records
Measured: 20 years
Disease control rate (DCR)
Collect detailed clinical information on patients with SCLC via the electronic medical records
Measured: 20 years
Progression-free survival (PFS)
Collect detailed clinical information on patients with SCLC via the electronic medical records
Measured: 20 years
Secondary outcomes (1)
Overall survival (OS)
Collect detailed clinical information on patients with SCLC via the electronic medical records
Measured: 20 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2024
- Study start1 Jan 2016
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung NeoplasmsStudies of the same condition, open and under way.
- More trials run by Shanghai Chest 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- Shanghai Chest Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiaomin Niu, Shanghai Chest Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06218901
- Sponsor's protocol ID
- THORACIC005
- Acronym
- Life-Score
- Status last verified
- May 2025
- First submitted
- 12 Jan 2024
- Last updated
- 22 May 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- the Association of Psychological Distress in Patients With Advanced Lung Cancer Treated With Immunotherapy or Targeted Therapy
- ClinicalTrials.gov ID
- NCT06218901
- Acronym / sponsor ID
- Life-Score / THORACIC005
- Conditions
- Lung Neoplasms, Psychological Distress, Prognosis Factors, Lifestyle, Healthy, IMMUNOTHERAPY, Targeted Molecular Therapy
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Shanghai Chest HospitalUniversity, hospital or other
- Study start
- 1 Jan 2016 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 23 Jan 2024 (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.
Psychological distress is a multi-factorial experience of a psychological, social, spiritual, and/or physical nature that may interfere with one's ability to cope effectively with cancer, physical symptoms and treatment. Psychological distress is common and affects the efficacy and prognosis of patients with lung cancer. The systematic anti-tumor therapy may effectively relieve psychological distress including anxiety, depression, and fatigue in patients with advanced lung cancer, the relief of the psychological distress can in turn improve the therapeutic effect.
In summary, this study is to explore the associations of (dynamic) psychological stress with the efficacy and survival of anti-tumor therapy including immunotherapy and targeted therapy for advanced lung cancer patients.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 3 Months
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Participants with lung cancer are with the standard treatment and/or are enrolled in the clinical trials.
Key inclusion criteria (3 listed)
- Histologically proven diagnosis of lung cancer
- 18 years of age or older
- Ability to understand and the willingness to sign a written informed consent document
Key exclusion criteria (1 listed)
- Not willing to participate in this clinical trial
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 |
|---|---|---|
| immunotherapy | Drug | – |
| Targeted Therapy Agent | Drug | – |
Primary outcome
Objective response rate (ORR)
Time frame: 20 years
Collect detailed clinical information on patients with SCLC via the electronic medical records
Disease control rate (DCR)
Time frame: 20 years
Collect detailed clinical information on patients with SCLC via the electronic medical records
Progression-free survival (PFS)
Time frame: 20 years
Collect detailed clinical information on patients with SCLC via the electronic medical records
1 secondary outcome
Overall survival (OS)
Time frame: 20 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2025.
- Individual participant dataSharing planned: Undecided
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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.
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 Neoplasms and Psychological Distress, run by Shanghai Chest 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 3 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 22 May 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xiaomin Niu ((86) 21 22200000 ext. 3703, ar_tey@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective response rate (ORR) (time frame: 20 years). The study lists 3 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 22 May 2025.