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RecruitingNCT06218901Life-ScoreUpdated May 22, 2025

Association of Psychological Distress in Patients With Lung Cancer

An observational study in Lung Neoplasms, Psychological Distress and Prognosis Factors, sponsored by Shanghai Chest Hospital. Recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-05-22.

Sponsored by Shanghai Chest Hospital · Observational

From the registry’s dates

  • Started Jan 2016; still recruiting 10 years 9 months later.
Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
500
Ages
18 Years and older
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Lung Neoplasms
  • Psychological Distress
  • Prognosis Factors
  • Lifestyle, Healthy
  • IMMUNOTHERAPY
  • Targeted Molecular Therapy

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03

In context

Lung Neoplasms

7,243 studies on the registry are indexed under Lung Neoplasms; 1,557 are open to participants now.

This study's planned enrollment of 500 is above the median of 189 across 1,514 observational studies indexed under Lung Neoplasms.

Browse Lung Neoplasms studies →

Lead sponsor

Shanghai Chest Hospital is the lead sponsor of 194 studies on the registry; 94 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Sampling method
Probability sample

Study population

Participants with lung cancer are with the standard treatment and/or are enrolled in the clinical trials.

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • Not willing to participate in this clinical trial
05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
500 participants (estimated)
Target follow-up
3 Months
Patient registry
Yes

Interventions

  • Drugimmunotherapy
  • DrugTargeted Therapy Agent
06

What researchers measure

Primary outcomes

  1. Objective response rate (ORR)

    Collect detailed clinical information on patients with SCLC via the electronic medical records

    Time frame: 20 years

  2. Disease control rate (DCR)

    Collect detailed clinical information on patients with SCLC via the electronic medical records

    Time frame: 20 years

  3. Progression-free survival (PFS)

    Collect detailed clinical information on patients with SCLC via the electronic medical records

    Time frame: 20 years

Secondary outcomes

  1. Overall survival (OS)

    Collect detailed clinical information on patients with SCLC via the electronic medical records

    Time frame: 20 years

07

Study locations

1 of 1 sites recruiting
  • Shanghai Chest Hospital
    Shanghai, Shanghai 200030, China
    • Xiaomin Niu · Contact · ar_tey@hotmail.com · (86) 21 22200000
    • Xiaomin Niu · Principal investigator
    Recruiting
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 22, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06218901
Lead sponsor
Shanghai Chest Hospital
Responsible party
Xiaomin Niu (Principal Investigator, Shanghai Chest Hospital) — Principal investigator
First posted
Jan 23, 2024
Start date
Jan 1, 2016
Primary completion
Dec 31, 2027 (estimated)
Completion
Dec 31, 2028 (estimated)
Last update
May 22, 2025

Study contacts

Xiaomin Niu
Contact
ar_tey@hotmail.com
(86) 21 22200000 ext. 3703

Oversight

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

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