Association of Psychological Distress in Patients With Lung Cancer

Lung Neoplasms Clinical Trial

— Life-Score  

Official title:

the Association of Psychological Distress in Patients With Advanced Lung Cancer Treated With Immunotherapy or Targeted Therapy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06218901
• Other study ID #: THORACIC005
• Status: Recruiting
• Start date: January 1, 2016
• Est. completion date: December 31, 2028

Study information

• Verified date: January 2024
• Source: Shanghai Chest Hospital
• Contact: Xiaomin Niu
• Phone: (86) 21 22200000
• Email: ar_tey[@]hotmail.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: December 31, 2028
• Est. primary completion date: December 31, 2027
• Gender: All
• Age group: 18 Years and older

Eligibility

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:

• Not willing to participate in this clinical trial

Related Conditions & MeSH terms

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

Intervention

Drug:
• immunotherapy

• Targeted Therapy Agent

Locations

Country	Name	City	State
China	Shanghai Chest Hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Chest Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Objective response rate (ORR)	Collect detailed clinical information on patients with SCLC via the electronic medical records	20 years
Primary	Disease control rate (DCR)	Collect detailed clinical information on patients with SCLC via the electronic medical records	20 years
Primary	Progression-free survival (PFS)	Collect detailed clinical information on patients with SCLC via the electronic medical records	20 years
Secondary	Overall survival (OS)	Collect detailed clinical information on patients with SCLC via the electronic medical records	20 years