NCT06218901

Brief 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.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
32mo left

Started Jan 2016

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress80%
Jan 2016Dec 2028

Study Start

First participant enrolled

January 1, 2016

Completed
8 years until next milestone

First Submitted

Initial submission to the registry

January 12, 2024

Completed
11 days until next milestone

First Posted

Study publicly available on registry

January 23, 2024

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2027

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2028

Last Updated

May 22, 2025

Status Verified

May 1, 2025

Enrollment Period

12 years

First QC Date

January 12, 2024

Last Update Submit

May 20, 2025

Conditions

Outcome Measures

Primary Outcomes (3)

  • Objective response rate (ORR)

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

    20 years

  • Disease control rate (DCR)

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

    20 years

  • Progression-free survival (PFS)

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

    20 years

Secondary Outcomes (1)

  • Overall survival (OS)

    20 years

Interventions

Eligibility Criteria

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

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

You may qualify if:

  • Histologically proven diagnosis of lung cancer
  • years of age or older
  • Ability to understand and the willingness to sign a written informed consent document

You may not qualify if:

  • Not willing to participate in this clinical trial

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shanghai Chest Hospital

Shanghai, Shanghai Municipality, 200030, China

RECRUITING

MeSH Terms

Conditions

Lung Neoplasms

Interventions

Immunotherapy

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

ImmunomodulationBiological TherapyTherapeutics

Central Study Contacts

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Target Duration
3 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 12, 2024

First Posted

January 23, 2024

Study Start

January 1, 2016

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

December 31, 2028

Last Updated

May 22, 2025

Record last verified: 2025-05

Locations